GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

233

Recruiting sites

—

Enrollment

987

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT00856986

Org study IDNN2211-1842

Secondary ID2007-005317-19

Timeline

Milestones

Study first posted2009-03-06estimated

Results first posted2011-05-13estimated

Last update posted2017-03-08actual

Study start2009-03 (month precision)

Primary completion2010-04actual (month precision)

Study completion2010-11actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age84 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator

•HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy

•HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea

Exclusion criteria

•Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)

•Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening

•Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator

•Impaired kidney function

•Impaired liver function

•Uncontrolled treated/untreated hypertension

•Cancer or any clinically significant disease or disorder as judged by the Investigator

•Previous participation in the run-in phase of this trial. Re-screening is allowed once

•History of chronic pancreatitis or idiopathic pancreatitis

Endpoints (64)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

16 endpoints

Secondary/registry result

Mean Change From Randomisation in Body Weight at Week 26

Time frame:Week 0 (Randomisation), Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 1.8	-0.95	—
Insulin Detemir + Lira 1.8	-0.16	—

Secondary/registry result

Mean Change From Randomisation 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 1.8	-1.02	—
Insulin Detemir + Lira 1.8	-0.05	—

Secondary/registry result

Mean Change From Randomisation in Waist Circumference at Week 26.

Time frame:Week 0 (Randomisation), Week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Lira 1.8	-0.66	—
Insulin Detemir + Lira 1.8	-0.78	—

Secondary/registry result

Mean Change From Randomisation 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 1.8	-0.83	—
Insulin Detemir + Lira 1.8	-0.83	—

Secondary/registry result

Mean Change From Randomisation in Hip Circumference at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Lira 1.8	-0.36	—
Insulin Detemir + Lira 1.8	-0.38	—

Secondary/registry result

Mean Change From Randomisation in Hip Circumference at Week 52

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Lira 1.8	-0.79	—
Insulin Detemir + Lira 1.8	-0.28	—

Secondary/registry result

Mean Change From Randomisation in Waist to Hip Ratio at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm/cm	95% CI
Lira 1.8	-0.00356	—
Insulin Detemir + Lira 1.8	-0.00332	—

Secondary/registry result

Mean Change From Randomisation 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 1.8	-0.00146	—
Insulin Detemir + Lira 1.8	-0.00438	—

Secondary/protocol endpoint

Mean Change From Randomisation in Body Weight at Week 26

Time frame:Week 0 (Randomisation), Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation 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 From Randomisation in Waist Circumference at Week 26.

Time frame:Week 0 (Randomisation), Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Waist Circumference at Week 52.

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Hip Circumference at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Hip Circumference at Week 52

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Waist to Hip Ratio at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 0, Week 52

change from baseline, improvement

Glycemic / diabetes

23 endpoints

Primary/registry result

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

Time frame:Week 0 (Randomisation), 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 1.8	0.02	—
Insulin Detemir + Lira 1.8	-0.51	—

Estimated Treatment Difference, LSMean-0.5295% CI-0.68 – -0.36ANCOVA

Primary/protocol endpoint

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

Time frame:Week 0 (Randomisation), week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

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 1.8	-0.1	—
Insulin Detemir + Lira 1.8	-0.51	—

Estimated Treatment Difference, LSMean-0.4195% CI-0.6 – -0.21ANCOVA

Secondary/registry result

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

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 1.8	0.01	—
Insulin Detemir + Lira 1.8	-0.5	—

Estimated treatment difference, LS mean-0.5195% CI-0.7 – -0.31ANCOVA

Secondary/registry result

Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

Time frame:Week 0 (Randomisation), Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8	-0.39	—
Insulin Detemir + Lira 1.8	-2.12	—

Secondary/registry result

Mean Change From Randomisation in Fasting Plasma Glucose 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 1.8	-0.14	—
Insulin Detemir + Lira 1.8	-1.91	—

Secondary/registry result

Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

Time frame:Week 0 (Randomisation), Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8Change at Breakfast, N=133, 144	-0.97	—
Change at Lunch, N= 134, 143	-0.83	—
Change at Dinner, N= 133, 139	-0.48	—
Insulin Detemir + Lira 1.8Change at Breakfast, N=133, 144	-2.09	—
Change at Lunch, N= 134, 143	-1.43	—
Change at Dinner, N= 133, 139	-1.18	—

Secondary/registry result

Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

Time frame:Week 0, Week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8Change at Breakfast, N=148, 135	-0.68	—
Change at Lunch, N= 145, 136	-0.51	—
Change at Dinner, N= 144, 135	-0.96	—
Insulin Detemir + Lira 1.8Change at Breakfast, N=148, 135	-2.43	—
Change at Lunch, N= 145, 136	-1.14	—
Change at Dinner, N= 144, 135	-1.4	—

Secondary/registry result

Mean Change From Randomisation in Fasting Insulin at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Secondary/registry result

Mean Change From Randomisation in Fasting Insulin at Week 52

Time frame:Week 0 (Randomisation), Week 52

change from baseline, improvement

Secondary/registry result

Mean Change From Randomisation in Fasting C-peptide at Week 26.

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8	-0.08	—
Insulin Detemir + Lira 1.8	-0.32	—

Secondary/registry result

Mean Change From Randomisation in Fasting C-peptide at Week 52.

Time frame:Week 0, Week 52

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8	0.02	—
Insulin Detemir + Lira 1.8	-0.34	—

Secondary/protocol endpoint

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

Time frame:Week 0 (Randomisation), Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting Plasma Glucose 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 Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

Time frame:Week 0 (Randomisation), Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

Time frame:Week 0, Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting Insulin at Week 26

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting Insulin at Week 52

Time frame:Week 0 (Randomisation), Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting Pro-insulin at Week 52

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting C-peptide at Week 26.

Time frame:Week 0 (Randomisation), Week 26

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Fasting C-peptide at Week 52.

Time frame:Week 0, Week 52

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

18 endpoints

Secondary/registry result

Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

Time frame:Week 0 (Randomisation), Week 26

fasting proinsulin

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Lira 1.8	-1.12	—
Insulin Detemir + Lira 1.8	-9.78	—

Secondary/registry result

Mean Change From Randomisation in Fasting Pro-insulin at Week 52

Time frame:Week 0, Week 52

fasting proinsulin

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Lira 1.8	1.47	—
Insulin Detemir + Lira 1.8	-4	—

Secondary/registry result

Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8Change in Total Cholesterol	0.04	—
Change in LDL-C	-0.04	—
Change in VLDL-C	0.05	—
Change in HDL-C	0.02	—
Insulin Detemir + Lira 1.8Change in Total Cholesterol	0.05	—
Change in LDL-C	-0.03	—
Change in VLDL-C	0.01	—
Change in HDL-C	0.05	—

Secondary/registry result

Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8Change in Total Cholesterol	-0.02	—
Change in LDL-C	-0.08	—
Change in VLDL-C	0.03	—
Change in HDL-C	0.02	—
Insulin Detemir + Lira 1.8Change in Total Cholesterol	-0.03	—
Change in LDL-C	-0.1	—
Change in VLDL-C	-0.03	—
Change in HDL-C	0.07	—

Secondary/registry result

Mean Change From Randomisation in Lipids: Triglycerides at Week 26

Time frame:Week 0 (Randomisation), Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8	-0.24	—
Insulin Detemir + Lira 1.8	-0.33	—

Secondary/registry result

Mean Change From Randomisation in Lipids: Triglycerides 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 1.8	-0.22	—
Insulin Detemir + Lira 1.8	-0.37	—

Secondary/registry result

Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

Time frame:Week 0 (Randomisation), Week 26

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 1.8	-0.03	—
Insulin Detemir + Lira 1.8	-0.11	—

Secondary/registry result

Mean Change From Randomisation in Lipids: 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 1.8	-0.03	—
Insulin Detemir + Lira 1.8	-0.07	—

Secondary/registry result

Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

Time frame:Week 0 (Randomisation), Week 26

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.8Systolic Blood Pressure	1.11	—
Diastolic Blood Pressure	-1.1	—
Insulin Detemir + Lira 1.8Systolic Blood Pressure	0.41	—
Diastolic Blood Pressure	-0.4	—

Secondary/registry result

Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

Time frame:Week 0, Week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 1.8Systolic Blood Pressure	-0.74	—
Diastolic Blood Pressure	-0.66	—
Insulin Detemir + Lira 1.8Systolic Blood Pressure	0.16	—
Diastolic Blood Pressure	0.11	—

Secondary/protocol endpoint

Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Lipids: Triglycerides at Week 26

Time frame:Week 0 (Randomisation), Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change From Randomisation in Lipids: Triglycerides at Week 52

Time frame:Week 0, Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

Time frame:Week 0 (Randomisation), Week 26

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Randomisation in Lipids: 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 From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

Time frame:Week 0, Week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Adverse Events From Run-in (Week -12) to Week 52

Time frame:Run-in (week -12) to Week 52

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Lira 1.8	716	—
Insulin Detemir + Lira 1.8	845	—
Non-Randomised Lira 1.8	2389	—
Early Withdrawals Lira 1.8	383	—
Intensified Group	30	—

Secondary/registry result

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

Time frame:weeks 0-26

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 1.8Major	0	—
Minor	2	—
Symptoms only	9	—
Insulin Detemir + Lira 1.8Major	0	—
Minor	22	—
Symptoms only	19	—
Non-Randomised Lira 1.8Major	0	—
Minor	31	—
Symptoms only	26	—

Secondary/registry result

Hypoglycaemic Episodes Weeks 0-52

Time frame:Week 0-52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), episodes	95% CI
Lira 1.8Major	0	—
Minor	4	—
Symptoms only	14	—
Unknown	0	—
Insulin Detemir + Lira 1.8Major	0	—
Minor	33	—
Symptoms only	57	—
Unknown	1	—
Non-Randomised Lira 1.8Major	0	—
Minor	53	—
Symptoms only	42	—
Unknown	2	—
Intensified GroupMajor	0	—
Minor	1	—
Symptoms only	2	—
Unknown	0	—

Secondary/protocol endpoint

Adverse Events From Run-in (Week -12) to Week 52

Time frame:Run-in (week -12) to Week 52

Treatment-emergent AEs (any)

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

Hypoglycaemic Episodes Weeks 0-52

Time frame:Week 0-52

Documented hypoglycemia

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

Time frame:Week 0 (Randomisation), Week 26

change from baseline, improvement

Publications (3)

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

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
One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target.
Journal of diabetes and its complications2013 Sep-Oct (year)PMID23746555doi:10.1016/j.jdiacomp.2013.04.008via CT.gov reference
Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets.
Diabetes care2012 Jul (month)PMID22584132doi:10.2337/dc11-1928via 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.