GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

166

Recruiting sites

—

Enrollment

665

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.5-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00700817

Org study IDNN2211-1860

Secondary ID2007-003937-17

Timeline

Milestones

Study first posted2008-06-19estimated

Results first posted2010-08-04estimated

Last update posted2017-03-08actual

Study start2008-06 (month precision)

Primary completion2009-06actual (month precision)

Study completion2010-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Treatment with metformin alone for at least three months

•HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)

•Body Mass Index (BMI) less than or equal to 45.0

Exclusion criteria

•Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors

•Treatment with anti-diabetic drugs other than metformin within the last three months

•Any serious medical condition

•Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Endpoints (150)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Patient-reported / QoL

Other (unclassified)

Heart failure

Weight & body composition

18 endpoints

Secondary/registry result

Mean Change From Baseline in Body Weight at Week 26

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.86	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.38	—
Sita -> Sita	-0.96	—

Secondary/registry result

Mean Change From Baseline in Body Weight at Week 52

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.78	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.68	—
Sita -> Sita	-1.16	—

Secondary/registry result

Mean Change in Body Weight From Week 52 to Week 78

Time frame:Week 52, Week 78

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Sita -> Sita -> Lira 1.2 mg	-1.64	—
Sita -> Sita -> Lira 1.8 mg	-2.48	—

Secondary/registry result

Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm/cm	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.01	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.01	—
Sita -> Sita	-0.00	—

Secondary/registry result

Mean Change From Baseline in Waist to Hip Ratio at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm/cm	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.00	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.01	—
Sita -> Sita	-0.00	—

Secondary/registry result

Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Posted result

Group	Value (mean), cm/cm	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.01	—
Sita -> Sita -> Lira 1.8 mg	-0.00	—

Secondary/registry result

Mean Change From Baseline in Waist Circumference at Week 26.

Time frame:Week 0, Week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.69	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.63	—
Sita -> Sita	-1.12	—

Secondary/registry result

Mean Change From Baseline in Waist Circumference at Week 52

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), participants	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.36	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.02	—
Sita -> Sita	-1.23	—

Secondary/registry result

Mean Change in Waist Circumference From Week 52 to Week 78

Time frame:Week 52, Week 78

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Sita -> Sita -> Lira 1.2 mg	-1.33	—
Sita -> Sita -> Lira 1.8 mg	-2.05	—

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at Week 26

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at Week 52

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Body Weight From Week 52 to Week 78

Time frame:Week 52, Week 78

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist to Hip Ratio at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist Circumference at Week 26.

Time frame:Week 0, Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist Circumference at Week 52

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Waist Circumference From Week 52 to Week 78

Time frame:Week 52, Week 78

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

38 endpoints

Primary/registry result

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage point of total HbA1c	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.24	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.5	—
Sita -> Sita	-0.9	—

Estimated treatment difference, LS Mean-0.695% CI-0.77 – -0.43p0.0001ANCOVA

ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.

Estimated treatment difference, LS Mean-0.3495% CI-0.51 – -0.16p0.0001ANCOVA

Primary/registry result

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage point of total HbA1c	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.29	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.51	—
Sita -> Sita	-0.88	—

Estimated Treatment Difference, LS Mean-0.6395% CI-0.81 – -0.44p0.0001ANCOVA

ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.

Estimated Treatment Difference, LS Mean-0.4095% CI-0.59 – -0.22p0.0001ANCOVA

ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.

Primary/registry result

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Time frame:Week 0, Week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage point of total HbA1c	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.94	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.28	—

Primary/registry result

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Time frame:Week 52, Week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of total HbA1c	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.24	—
Sita -> Sita -> Lira 1.8 mg	-0.45	—

Change within treatment group-0.2495% CI-0.41 – -0.07p0.0060paired t-test

The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.

Change within treatment group-0.4595% CI-0.67 – -0.23p0.0001paired t-test

The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.

Primary/protocol endpoint

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Time frame:Week 0, Week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Time frame:Week 52, Week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Time frame:Week 0, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	43	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	55	—
Sita -> Sita	22	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Time frame:Week 0, Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	50	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	63	—
Sita -> Sita	27	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Time frame:Week 0, Week 78

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	35	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	51	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Time frame:Week 0, Week 78

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Sita -> Sita -> Lira 1.2 mg	49	—
Sita -> Sita -> Lira 1.8 mg	50	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Time frame:Week 0, Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	23	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	36	—
Sita -> Sita	12	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Time frame:Week 0, Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	24	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	40	—
Sita -> Sita	17	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Time frame:Week 0, Week 78

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	12	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	27	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Time frame:Week 0, Week 78

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Sita -> Sita -> Lira 1.2 mg	29	—
Sita -> Sita -> Lira 1.8 mg	25	—

Secondary/registry result

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.87	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.14	—
Sita -> Sita	-0.83	—

Secondary/registry result

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.71	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.04	—
Sita -> Sita	-0.59	—

Secondary/registry result

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Time frame:Week 0, Week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.30	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.65	—

Secondary/registry result

Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Time frame:Week 52, Week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.84	—
Sita -> Sita -> Lira 1.8 mg	-1.42	—

Secondary/registry result

Mean Change From Baseline in Beta-cell Function at Week 26

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage point	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	27.23	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	28.70	—
Sita -> Sita	4.18	—

Secondary/registry result

Mean Change From Baseline in Beta-cell Function at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage point	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	22.58	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	25.76	—
Sita -> Sita	3.98	—

Secondary/registry result

Mean Change in Beta-cell Function From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Posted result

Group	Value (mean), percentage point	95% CI
Sita -> Sita -> Lira 1.2 mg	13.31	—
Sita -> Sita -> Lira 1.8 mg	23.09	—

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Time frame:Week 0, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Time frame:Week 0, Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Time frame:Week 0, Week 78

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Time frame:Week 0, Week 78

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Time frame:Week 0, Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Time frame:Week 0, Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Time frame:Week 0, Week 78

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Time frame:Week 0, Week 78

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Time frame:Week 0, Week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Time frame:Week 52, Week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Baseline in Beta-cell Function at Week 26

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Beta-cell Function at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Beta-cell Function From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Heart failure

2 endpoints

Secondary/registry result

Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Time frame:Week 0, Week 26

NT-proBNP, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	5.19	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.74	—
Sita -> Sita	3.71	—

Secondary/protocol endpoint

Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Time frame:Week 0, Week 26

NT-proBNP, change

change from baseline, improvement

Cardiometabolic biomarkers

69 endpoints

Secondary/registry result

Mean Change From Baseline in Total Cholesterol at Week 26

Time frame:Week 0, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.17	—
Sita -> Sita	-0.02	—

Secondary/registry result

Mean Change From Baseline in Total Cholesterol at Week 52

Time frame:Week 0, Week 52

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.01	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.09	—
Sita -> Sita	0.03	—

Secondary/registry result

Mean Change in Total Cholesterol From Week 52 to Week 78

Time frame:Week 52, Week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.16	—
Sita -> Sita -> Lira 1.8 mg	-0.24	—

Secondary/registry result

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Time frame:Week 0, Week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.08	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.05	—
Sita -> Sita	0.13	—

Secondary/registry result

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Time frame:Week 0, Week 52

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.09	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.09	—
Sita -> Sita	0.17	—

Secondary/registry result

Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Time frame:Week 52, Week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.22	—
Sita -> Sita -> Lira 1.8 mg	-0.25	—

Secondary/registry result

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Time frame:Week 0, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.00	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.00	—
Sita -> Sita	0.00	—

Secondary/registry result

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Time frame:Week 0, Week 52

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.01	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.02	—
Sita -> Sita	0.01	—

Secondary/registry result

Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Time frame:Week 52, Week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	0.02	—
Sita -> Sita -> Lira 1.8 mg	-0.01	—

Secondary/registry result

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Time frame:Week 0, Week 26

VLDL, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.11	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.20	—
Sita -> Sita	-0.15	—

Secondary/registry result

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Time frame:Week 0, Week 52

VLDL, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.11	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.19	—
Sita -> Sita	-0.15	—

Secondary/registry result

Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Time frame:Week 52, Week 78

VLDL, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	0.03	—
Sita -> Sita -> Lira 1.8 mg	0.02	—

Secondary/registry result

Mean Change From Baseline in Triglycerides (TG) at Week 26

Time frame:Week 0, Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.19	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.43	—
Sita -> Sita	-0.40	—

Secondary/registry result

Mean Change From Baseline in Triglycerides (TG) at Week 52

Time frame:Week 0, Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.10	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.32	—
Sita -> Sita	-0.23	—

Secondary/registry result

Mean Change in Triglycerides (TG) From Week 52 to Week 78

Time frame:Week 52, Week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.20	—
Sita -> Sita -> Lira 1.8 mg	-0.26	—

Secondary/registry result

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Time frame:Week 0, Week 26

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.07	—
Sita -> Sita	-0.05	—

Secondary/registry result

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Time frame:Week 0, Week 52

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.07	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.10	—
Sita -> Sita	-0.06	—

Secondary/registry result

Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Time frame:Week 52, Week 78

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	0.02	—
Sita -> Sita -> Lira 1.8 mg	-0.01	—

Secondary/registry result

Mean Change From Baseline in Apolipoprotein B at Week 26

Time frame:Week 0, Week 26

ApoB, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), g/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.06	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.07	—
Sita -> Sita	-0.05	—

Secondary/registry result

Mean Change From Baseline in Apolipoprotein B at Week 52

Time frame:Week 0, Week 52

ApoB, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), g/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.03	—
Sita -> Sita	-0.03	—

Secondary/registry result

Mean Change in Apolipoprotein B From Week 52 to Week 78

Time frame:Week 52, Week 78

ApoB, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Sita -> Sita -> Lira 1.2 mg	0.23	—
Sita -> Sita -> Lira 1.8 mg	0.17	—

Secondary/registry result

Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Time frame:Week 0, Week 26

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (least_squares_mean), mg/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.02	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.99	—
Sita -> Sita	-0.66	—

Secondary/registry result

Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), U/L	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-833	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-561	—
Sita -> Sita	586	—

Secondary/registry result

Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Time frame:Week 0, Week 26

IL-6

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.70	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	1.71	—
Sita -> Sita	0.91	—

Secondary/registry result

Mean Change From Baseline in Adiponectin at Week 26.

Time frame:Week 0, Week 26

Adiponectin, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mcg/mL	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1.69	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	1.51	—
Sita -> Sita	1.35	—

Secondary/registry result/low confidence

Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.55	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.74	—
Sita -> Sita	-0.53	—

Secondary/registry result

Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage point	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.73	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-4.34	—
Sita -> Sita	-1.8	—

Secondary/registry result

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Time frame:Week 0, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.55	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.72	—
Sita -> Sita	-0.94	—

Secondary/registry result

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Time frame:Week 0, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.37	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.55	—
Sita -> Sita	-1.03	—

Secondary/registry result

Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Time frame:Week 52, Week 78

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Sita -> Sita -> Lira 1.2 mg	-2.12	—
Sita -> Sita -> Lira 1.8 mg	0.35	—

Secondary/registry result

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Time frame:Week 0, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.71	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.07	—
Sita -> Sita	-1.78	—

Secondary/registry result

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Time frame:Week 0, Week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.53	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.87	—
Sita -> Sita	-1.47	—

Secondary/registry result

Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Time frame:Week 52, Week 78

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Sita -> Sita -> Lira 1.2 mg	-0.60	—
Sita -> Sita -> Lira 1.8 mg	0.03	—

Secondary/registry result

Mean Change From Baseline in Pulse at Week 26

Time frame:Week 0, Week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats/minute	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	2.32	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.94	—
Sita -> Sita	-0.64	—

Secondary/registry result

Mean Change From Baseline in Pulse at Week 52

Time frame:Week 0, Week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1.72	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.09	—
Sita -> Sita	0.09	—

Secondary/registry result

Mean Change in Pulse From Week 52 to Week 78

Time frame:Week 52, Week 78

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/minute	95% CI
Sita -> Sita -> Lira 1.2 mg	0.90	—
Sita -> Sita -> Lira 1.8 mg	2.19	—

Secondary/protocol endpoint

Mean Change From Baseline in Total Cholesterol at Week 26

Time frame:Week 0, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Mean Change From Baseline in Total Cholesterol at Week 52

Time frame:Week 0, Week 52

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Mean Change in Total Cholesterol From Week 52 to Week 78

Time frame:Week 52, Week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Time frame:Week 0, Week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Time frame:Week 0, Week 52

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Time frame:Week 52, Week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Time frame:Week 0, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Time frame:Week 0, Week 52

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Time frame:Week 52, Week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Time frame:Week 0, Week 26

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Time frame:Week 0, Week 52

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Time frame:Week 52, Week 78

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Triglycerides (TG) at Week 26

Time frame:Week 0, Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change From Baseline in Triglycerides (TG) at Week 52

Time frame:Week 0, Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change in Triglycerides (TG) From Week 52 to Week 78

Time frame:Week 52, Week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Time frame:Week 0, Week 26

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Time frame:Week 0, Week 52

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Time frame:Week 52, Week 78

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Apolipoprotein B at Week 26

Time frame:Week 0, Week 26

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Apolipoprotein B at Week 52

Time frame:Week 0, Week 52

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Apolipoprotein B From Week 52 to Week 78

Time frame:Week 52, Week 78

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Time frame:Week 0, Week 26

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Adiponectin at Week 26.

Time frame:Week 0, Week 26

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Time frame:Week 0, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Time frame:Week 0, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Time frame:Week 52, Week 78

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Time frame:Week 0, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Time frame:Week 0, Week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Time frame:Week 52, Week 78

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Mean Change From Baseline in Pulse at Week 26

Time frame:Week 0, Week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Pulse at Week 52

Time frame:Week 0, Week 52

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Pulse From Week 52 to Week 78

Time frame:Week 52, Week 78

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

6 endpoints

Secondary/registry result

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

Time frame:Week 0, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), scores on a scale	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	3.51	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	4.35	—
Sita -> Sita	2.96	—

Secondary/registry result

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), scores on a scale	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	3.32	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	4.31	—
Sita -> Sita	2.96	—

Secondary/registry result

Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Sita -> Sita -> Lira 1.2 mg	1.48	—
Sita -> Sita -> Lira 1.8 mg	0.98	—

Secondary/protocol endpoint

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

Time frame:Week 0, Week 52

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

Time frame:Week 52, Week 78

change from baseline, improvement

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Hypoglyceamic Episodes, Weeks 0-26

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	1	—
Minor	17	—
Symptoms only	12	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	37	—
Symptoms only	15	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	11	—
Symptoms only	10	—
Unclassified	0	—

Secondary/registry result

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	1	—
Minor	17	—
Symptoms only	12	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	16	—
Symptoms only	15	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	11	—
Symptoms only	10	—
Unclassified	0	—

Secondary/registry result

Hypoglyceamic Episodes, Weeks 0-52

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	1	—
Minor	24	—
Symptoms only	14	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	51	—
Symptoms only	29	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	25	—
Symptoms only	12	—
Unclassified	0	—

Secondary/registry result

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	1	—
Minor	24	—
Symptoms only	14	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	28	—
Symptoms only	29	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	25	—
Symptoms only	12	—
Unclassified	0	—

Secondary/registry result

Hypoglyceamic Episodes, Weeks 0-78

Time frame:Weeks 0-78

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	2	—
Minor	36	—
Symptoms only	18	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	56	—
Symptoms only	40	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	34	—
Symptoms only	13	—
Unclassified	0	—

Secondary/registry result

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Time frame:Weeks 0-78

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	2	—
Minor	36	—
Symptoms only	18	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	33	—
Symptoms only	40	—
Unclassified	1	—
Sita -> SitaMajor	0	—
Minor	34	—
Symptoms only	13	—
Unclassified	0	—

Secondary/registry result

Hypoglycaamic Episodes, Weeks 52-78

Time frame:Week 52-78

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgMajor	1	—
Minor	12	—
Symptoms only	3	—
Unclassified	0	—
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgMajor	0	—
Minor	5	—
Symptoms only	11	—
Unclassified	0	—
Sita -> Sita -> Lira 1.2 mgMajor	0	—
Minor	3	—
Symptoms only	1	—
Unclassified	0	—
Sita -> Sita -> Lira 1.8 mgMajor	0	—
Minor	6	—
Symptoms only	0	—
Unclassified	0	—

Secondary/protocol endpoint

Hypoglyceamic Episodes, Weeks 0-26

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglyceamic Episodes, Weeks 0-52

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglyceamic Episodes, Weeks 0-78

Time frame:Weeks 0-78

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Time frame:Weeks 0-78

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglycaamic Episodes, Weeks 52-78

Time frame:Week 52-78

Documented hypoglycemia

event count, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Time frame:Week 0, Week 26

change from baseline, improvement

Publications (15)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials.
Diabetes, obesity & metabolism2016 Jul (month)PMID26936426doi:10.1111/dom.12653via CT.gov reference
Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.
Diabetes care2015 Jun (month)PMID25504028doi:10.2337/dc13-1210via CT.gov reference
Incretin therapy for type 2 diabetes in Spain: a cost-effectiveness analysis of liraglutide versus sitagliptin.
Diabetes therapy : research, treatment and education of diabetes and related disorders2013 Dec (month)PMID24132613doi:10.1007/s13300-013-0044-9via pubmed nct search
Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States.
Journal of managed care pharmacy : JMCP2013 Apr (month)PMID23537458doi:10.18553/jmcp.2013.19.3.237via clinicaltrials gov reference derived + pubmed nct search
Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2013 Jan-Feb (year)PMID23186975doi:10.4158/EP12232.ORvia CT.gov reference
Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.
Diabetes, obesity & metabolism2013 Jan (month)PMID22862847doi:10.1111/j.1463-1326.2012.01673.xvia CT.gov reference
A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Diabetes research and clinical practice2012 Nov (month)PMID23010561doi:10.1016/j.diabres.2012.09.008via CT.gov reference
Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial.
Diabetes care2012 Oct (month)PMID22851600doi:10.2337/dc11-2113via CT.gov reference
Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus.
Diabetic medicine : a journal of the British Diabetic Association2012 Mar (month)PMID21883438doi:10.1111/j.1464-5491.2011.03429.xvia CT.gov reference
Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis.
Journal of medical economics2012 (year)PMID22834986doi:10.3111/13696998.2012.716111via CT.gov reference
Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme.
Diabetes, obesity & metabolism2012 Jan (month)PMID21883806doi:10.1111/j.1463-1326.2011.01493.xvia CT.gov reference
One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial.
International journal of clinical practice2011 Apr (month)PMID21355967doi:10.1111/j.1742-1241.2011.02656.xvia CT.gov reference + pubmed nct search
Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin.
Diabetic medicine : a journal of the British Diabetic Association2011 Mar (month)PMID21309842doi:10.1111/j.1464-5491.2010.03074.xvia CT.gov reference
Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2011 Nov-Dec (year)PMID22193143doi:10.4158/ep.17.6.906via CT.gov reference
Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial.
Lancet (London, England)2010 Apr 24PMID20417856doi:10.1016/S0140-6736(10)60307-8via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.