LEAD-6

CompletedPhase 3Results posted

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Exenatide / Liraglutide

Listed sites

125

Recruiting sites

—

Enrollment

467

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c ≥7%

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 IDNCT00518882

Org study IDNN2211-1797

Secondary ID2006-006092-21

Timeline

Milestones

Study first posted2007-08-21estimated

Results first posted2010-03-23estimated

Last update posted2017-03-08actual

Study start2007-08 (month precision)

Primary completion2008-04actual (month precision)

Study completion2009-04actual (month precision)

Assets

Investigational agents

Exenatide 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

•Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator

•HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%

•Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

Exclusion criteria

•Previous treatment with insulin

•Treatment with any anti-diabetic drug other than metformin and sulphonylurea

•Any previous exposure to exenatide or liraglutide

•Impaired liver or/and renal function

•History of any significant cardiac events

•Known retinopathy or maculopathy requiring acute treatment

•Recurrent major hypoglycaemia or hypoglycaemic unawareness

Endpoints (110)

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

Weight & body composition

6 endpoints

Secondary/registry result

Change 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
Liraglutide -> Liraglutide -> Liraglutide	-3.24	—
Exenatide -> Liraglutide -> Liraglutide	-2.87	—

Estimated treatment difference, LS Mean-0.3895% CI-0.99 – 0.23p0.2235ANCOVA

Secondary/registry result

Change in Body Weight, Weeks 26-78

Time frame:week 26, week 78

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.4	—
Exenatide -> Liraglutide -> Liraglutide	-0.7	—

Mean-0.495% CI-0.86 – 0.05p0.0793Paired t test

Mean-0.795% CI-1.26 – -0.20p0.0075Paired t test

Secondary/registry result

Change in Body Weight at Week 78

Time frame:week 0, week 78

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-3.3	—
Exenatide -> Liraglutide -> Liraglutide	-3.2	—

Mean-3.395% CI-3.90 – -2.61p<0.0001Paired t test

Mean-3.295% CI-3.85 – -2.55p<0.0001Paired t test

Secondary/protocol endpoint

Change in Body Weight at Week 26

Time frame:week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight, Weeks 26-78

Time frame:week 26, week 78

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight at Week 78

Time frame:week 0, week 78

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

58 endpoints

Primary/registry result

Change in Glycosylated 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
Liraglutide -> Liraglutide -> Liraglutide	-1.12	—
Exenatide -> Liraglutide -> Liraglutide	-0.79	—

Estimated treatment difference, LS Mean-0.3395% CI-0.47 – -0.18p<.0001ANCOVA

Primary/protocol endpoint

Change in Glycosylated A1c (HbA1c) at Week 26

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Glycosylated A1c (HbA1c), Weeks 26-78

Time frame:week 26, week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage point of total HbA1c	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.25	—
Exenatide -> Liraglutide -> Liraglutide	-0.00	—

Mean0.2595% CI0.139 – 0.364p<0.0001Paired t-test

Mean-0.0095% CI-1.36 – 0.134p0.9872Paired t-test

Secondary/registry result

Change in Glycosylated A1c (HbA1c) at Week 78

Time frame:week 0, week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage point of total HbA1c	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.98	—
Exenatide -> Liraglutide -> Liraglutide	-0.85	—

Mean-0.9895% CI-1.137 – -0.823p<0.0001Paired t-test

Mean-0.8595% CI-1.010 – -0.687p<0.0001Paired t-test

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 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
Liraglutide -> Liraglutide -> LiraglutideTreatment target HbA1c < 7%	53	—
Treatment target HbA1c =< 6.5%	34	—
Exenatide -> Liraglutide -> LiraglutideTreatment target HbA1c < 7%	42	—
Treatment target HbA1c =< 6.5%	20	—

Secondary/registry result

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% 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
Liraglutide -> Liraglutide -> LiraglutideTreatment target HbA1c < 7%	47	—
Treatment target HbA1c =< 6.5%	31	—
Exenatide -> Liraglutide -> LiraglutideTreatment target HbA1c < 7%	48	—
Treatment target HbA1c =< 6.5%	35	—

Secondary/registry result

Change in Fasting Plasma Glucose 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
Liraglutide -> Liraglutide -> Liraglutide	-1.61	—
Exenatide -> Liraglutide -> Liraglutide	-0.60	—

Estimated treatment difference, LS Mean-1.0195% CI-1.37 – -0.65p<0.0001ANCOVA

Secondary/registry result

Change in Fasting Plasma Glucose, Weeks 26-78

Time frame:week 26, week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.7	—
Exenatide -> Liraglutide -> Liraglutide	-0.1	—

Mean0.795% CI0.48 – 1.00p<0.0001Paired t test

Mean-0.195% CI-0.48 – 0.23p0.4864Paired t test

Secondary/registry result

Change in Fasting Plasma Glucose at Week 78

Time frame:week 0, week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-1.3	—
Exenatide -> Liraglutide -> Liraglutide	-0.8	—

Mean-1.395% CI-1.62 – -0.92p<0.0001Paired t test

Mean-0.895% CI-1.23 – -0.42p<0.0001Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.83	—
Exenatide -> Liraglutide -> Liraglutide	-2.16	—

Estimated treatment difference, LS Mean1.3395% CI0.80 – 1.86p<.0001ANCOVA

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.06	—
Exenatide -> Liraglutide -> Liraglutide	0.06	—

Estimated treatment difference, LS Mean0.0195% CI-0.52 – 0.53p0.9849ANCOVA

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-1.10	—
Exenatide -> Liraglutide -> Liraglutide	-2.11	—

LS Mean1.0195% CI0.44 – 1.57p0.0005ANCOVA

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.22	—
Exenatide -> Liraglutide -> Liraglutide	1.15	—

Mean-0.2295% CI-0.626 – 0.192p0.2972Paired t test

Mean1.1595% CI0.660 – 1.637p<0.0001Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.05	—
Exenatide -> Liraglutide -> Liraglutide	-0.09	—

Mean0.0595% CI-0.424 – 0.521p0.8396Paired t test

Mean-0.0995% CI-0.604 – 0.423p0.7278Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.22	—
Exenatide -> Liraglutide -> Liraglutide	1.07	—

Mean0.2295% CI-0.219 – 0.654p0.3271Paired t test

Mean1.0795% CI0.497 – 1.634p0.0003Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-1.08	—
Exenatide -> Liraglutide -> Liraglutide	-0.99	—

Mean-1.0895% CI-1.605 – -0.562p<0.0001Paired t test

Mean-0.9995% CI-1.517 – -0.458p0.0003Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.26	—
Exenatide -> Liraglutide -> Liraglutide	-0.37	—

Mean0.2695% CI-0.331 – 0.853p0.3859Paired t test

Mean-0.3795% CI-0.956 – 0.214p0.2119Paired t test

Secondary/registry result

Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.35	—
Exenatide -> Liraglutide -> Liraglutide	-0.95	—

Mean-0.3595% CI-0.917 – 0.2211p0.2290Paired t test

Mean-0.9595% CI-1.449 – -0.459p0.0002Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-3.20	—
Exenatide -> Liraglutide -> Liraglutide	-3.93	—

Estimated treatment difference, LS Mean0.7395% CI0.16 – 1.31p0.0124ANCOVA

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26

Time frame:week 0. week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-2.74	—
Exenatide -> Liraglutide -> Liraglutide	-2.35	—

Estimated treatment difference, LS Mean-0.3995% CI-0.91 – 0.13p0.1430ANCOVA

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-3.05	—
Exenatide -> Liraglutide -> Liraglutide	-3.59	—

Estimated treatment difference, LS Mean0.5495% CI0.03 – 1.05p0.0380ANCOVA

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.06	—
Exenatide -> Liraglutide -> Liraglutide	0.72	—

Mean0.0695% CI-0.344 – 0.463p0.7700Paired t test

Mean0.7295% CI0.230 – 1.212p0.0042Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.67	—
Exenatide -> Liraglutide -> Liraglutide	-0.09	—

Mean0.6795% CI0.238 – 1.106p0.0026Paired t test

Mean-0.0995% CI-0.541 – 0.356p0.6845Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.32	—
Exenatide -> Liraglutide -> Liraglutide	0.58	—

Mean0.3295% CI-0.066 – 0.706p0.1041Paired t test

Mean0.5895% CI0.114 – 1.052p0.0151Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-3.31	—
Exenatide -> Liraglutide -> Liraglutide	-3.13	—

Mean-3.3195% CI-3.861 – -2.763p<0.0001Paired t test

Mean-3.1395% CI-3.673 – -2.589p<0.0001Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-1.93	—
Exenatide -> Liraglutide -> Liraglutide	-2.17	—

Mean-1.9395% CI-2.457 – -1.403p<0.0001Paired t test

Mean-2.1795% CI-2.731 – -1.618p<0.0001Paired t test

Secondary/registry result

Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-2.21	—
Exenatide -> Liraglutide -> Liraglutide	-2.55	—

Mean-2.2195% CI-2.747 – -1.676p<0.0001Paired t test

Mean-2.5595% CI-3.104 – -1.997p<0.0001Paired t test

Secondary/registry result

Change 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 (%point)	95% CI
Liraglutide -> Liraglutide -> Liraglutide	32.12	—
Exenatide -> Liraglutide -> Liraglutide	2.74	—

Estimated treatment difference, LS Mean29.3795% CI16.81 – 41.93p<.0001ANCOVA

Secondary/registry result

Change in Beta-cell Function, Weeks 26-78

Time frame:week 26, week 78

change from baseline, improvement

Posted result

Group	Value (mean), percentage point (%point)	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-18.18	—
Exenatide -> Liraglutide -> Liraglutide	2.29	—

Mean-18.1895% CI-26.988 – -9.382p<0.0001Paired t test

Mean2.4995% CI-5.327 – 10.307p0.5304Paired t test

Secondary/registry result

Change in Beta-cell Function at Week 78

Time frame:week 0, week 78

change from baseline, improvement

Posted result

Group	Value (mean), percentage point (%point)	95% CI
Liraglutide -> Liraglutide -> Liraglutide	24.86	—
Exenatide -> Liraglutide -> Liraglutide	11.13	—

Mean24.8695% CI16.348 – 33.374p<0.0001Paired t test

Mean11.1395% CI-1.835 – 24.093p0.0920Paired t test

Secondary/protocol endpoint

Change in Glycosylated A1c (HbA1c), Weeks 26-78

Time frame:week 26, week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Glycosylated A1c (HbA1c) at Week 78

Time frame:week 0, week 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% 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 Either HbA1c < 7.0% or =< 6.5% at Week 78

Time frame:week 0, week 78

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose at Week 26

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Plasma Glucose, Weeks 26-78

Time frame:week 26, week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Plasma Glucose at Week 78

Time frame:week 0, week 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26

Time frame:week 0. week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Time frame:week 26, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78

Time frame:week 0, week 78

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Beta-cell Function at Week 26

Time frame:week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Beta-cell Function, Weeks 26-78

Time frame:week 26, week 78

change from baseline, improvement

Secondary/protocol endpoint

Change in Beta-cell Function at Week 78

Time frame:week 0, week 78

change from baseline, improvement

Cardiometabolic biomarkers

42 endpoints

Secondary/registry result

Change 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
Liraglutide -> Liraglutide -> Liraglutide	-0.20	—
Exenatide -> Liraglutide -> Liraglutide	-0.09	—

Estimated treatment difference, LS Mean-0.1195% CI-0.23 – 0.02p0.0946ANCOVA

Secondary/registry result

Change in Total Cholesterol, Weeks 26-78

Time frame:week 26, week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.11	—
Exenatide -> Liraglutide -> Liraglutide	0.12	—

Mean0.1195% CI-0.001 – 0.216p0.0513Paired t test

Mean0.1295% CI-0.001 – 0.233p0.0513Paired t test

Secondary/registry result

Change in Total Cholesterol at Week 78

Time frame:week 0, week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.07	—
Exenatide -> Liraglutide -> Liraglutide	0.09	—

Mean-0.0795% CI-0.187 – 0.054p0.2764Paired t test

Mean0.0995% CI-0.043 – 0.216p0.1911Paired t test

Secondary/registry result

Change in Low-density Lipoprotein-cholesterol 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
Liraglutide -> Liraglutide -> Liraglutide	-0.44	—
Exenatide -> Liraglutide -> Liraglutide	-0.40	—

Estimated treatment difference, LS Mean-0.0495% CI-0.15 – 0.06p0.4412ANCOVA

Secondary/registry result

Change in Low-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.03	—
Exenatide -> Liraglutide -> Liraglutide	0.08	—

Mean0.0395% CI-0.054 – 0.115p0.4746Paired t test

Mean0.0895% CI-0.024 – 0.188p0.1281Paired t test

Secondary/registry result

Change in Low-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.30	—
Exenatide -> Liraglutide -> Liraglutide	-0.21	—

Mean-0.3095% CI-0.390 – -0.214p<0.0001Paired t test

Mean-0.2195% CI-0.303 – -0.110p<0.0001Paired t test

Secondary/registry result

Change in Very Low-density Lipoprotein-cholesterol 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
Liraglutide -> Liraglutide -> Liraglutide	0.20	—
Exenatide -> Liraglutide -> Liraglutide	0.27	—

Estimated treatment difference, LS Mean-0.0795% CI-0.13 – -0.01p0.0277ANCOVA

Secondary/registry result

Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

VLDL, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.06	—
Exenatide -> Liraglutide -> Liraglutide	0.03	—

Mean0.0695% CI0.021 – 0.102p0.0030Paired t test

Mean0.0395% CI-0.012 – 0.079p0.1452Paired t test

Secondary/registry result

Change in Very Low-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

VLDL, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.27	—
Exenatide -> Liraglutide -> Liraglutide	0.31	—

Mean0.2795% CI0.223 – 0.315p<0.0001Paired t test

Mean0.3195% CI0.259 – 0.364p<0.0001Paired t test

Secondary/registry result

Change in High-density Lipoprotein-cholesterol 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
Liraglutide -> Liraglutide -> Liraglutide	-0.04	—
Exenatide -> Liraglutide -> Liraglutide	-0.05	—

Estimated treatment difference, LS Mean0.0195% CI-0.02 – 0.04p0.5105ANCOVA

Secondary/registry result

Change in High-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.01	—
Exenatide -> Liraglutide -> Liraglutide	0.00	—

Mean-0.0195% CI-0.034 – 0.008p0.2220Paired t test

Mean0.0095% CI-0.018 – 0.024p0.7923Paired t test

Secondary/registry result

Change in High-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.03	—
Exenatide -> Liraglutide -> Liraglutide	-0.02	—

Mean-0.0395% CI-0.050 – -0.003p0.0254Paired t test

Mean-0.0295% CI-0.040 – 0.009p0.2244Paired t test

Secondary/registry result

Change in Triglyceride 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
Liraglutide -> Liraglutide -> Liraglutide	-0.41	—
Exenatide -> Liraglutide -> Liraglutide	-0.23	—

Estimated treatment difference, LS Mean-0.1895% CI-0.37 – -0.00p0.0485ANCOVA

Secondary/registry result

Change in Triglyceride, Weeks 26-78

Time frame:week 26, week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.1	—
Exenatide -> Liraglutide -> Liraglutide	-0.0	—

Mean0.195% CI-0.02 – 0.21p0.1161Paired t test

Mean-0.095% CI-0.16 – 0.12p0.7888Paired t test

Secondary/registry result

Change in Triglyceride at Week 78

Time frame:week 0, week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.3	—
Exenatide -> Liraglutide -> Liraglutide	-0.1	—

Mean-0.395% CI-0.43 – -0.13p0.0003Paired t test

Mean-0.195% CI-0.35 – 0.08p0.2078Paired t test

Secondary/registry result

Change in Free Fatty Acid 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
Liraglutide -> Liraglutide -> Liraglutide	-0.17	—
Exenatide -> Liraglutide -> Liraglutide	-0.10	—

Estimated treatment difference, LS Mean-0.0795% CI-0.11 – -0.03p0.0014ANCOVA

Secondary/registry result

Change in Free Fatty Acid, Weeks 26-78

Time frame:week 26, week 78

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	0.06	—
Exenatide -> Liraglutide -> Liraglutide	0.01	—

Mean0.0695% CI0.023 – 0.098p0.0018Paired t test

Mean0.0195% CI-0.028 – 0.052p0.5499Paired t test

Secondary/registry result

Change in Free Fatty Acid at Week 78

Time frame:week 0, week 78

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.10	—
Exenatide -> Liraglutide -> Liraglutide	-0.07	—

Mean-0.1095% CI-0.140 – -0.062p<0.0001Paired t test

Mean-0.0795% CI-0.118 – -0.030p0.0012Paired t test

Secondary/registry result

Change 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
Liraglutide -> Liraglutide -> Liraglutide	-0.06	—
Exenatide -> Liraglutide -> Liraglutide	-0.03	—

Estimated treatment difference, LS Mean-0.0295% CI-0.05 – 0.01p0.1119ANCOVA

Secondary/registry result

Change in Apolipoprotein B, Weeks 26-78

Time frame:week 26, week 78

ApoB, change

change from baseline, improvement

Posted result

Group	Value (mean), g/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.02	—
Exenatide -> Liraglutide -> Liraglutide	-0.03	—

Mean-0.0295% CI-0.041 – 0.006p0.1342Paired t test

Mean-0.0395% CI-0.057 – -0.002p0.0344Paired t test

Secondary/registry result

Change in Apolipoprotein B at Week 78

Time frame:week 0, week 78

ApoB, change

change from baseline, improvement

Posted result

Group	Value (mean), g/L	95% CI
Liraglutide -> Liraglutide -> Liraglutide	-0.08	—
Exenatide -> Liraglutide -> Liraglutide	-0.07	—

Mean-0.0895% CI-0.105 – -0.056p<0.0001Paired t test

Mean-0.0795% CI-0.094 – -0.038p<0.0001Paired t test

Secondary/protocol endpoint

Change 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

Change in Total Cholesterol, Weeks 26-78

Time frame:week 26, week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Total Cholesterol at Week 78

Time frame:week 0, week 78

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Low-density Lipoprotein-cholesterol at Week 26

Time frame:week 0, week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Low-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Low-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low-density Lipoprotein-cholesterol at Week 26

Time frame:week 0, week 26

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Very Low-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in High-density Lipoprotein-cholesterol at Week 26

Time frame:week 0, week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in High-density Lipoprotein-cholesterol, Weeks 26-78

Time frame:week 26, week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in High-density Lipoprotein-cholesterol at Week 78

Time frame:week 0, week 78

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglyceride at Week 26

Time frame:week 0, week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Triglyceride, Weeks 26-78

Time frame:week 26, week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Triglyceride at Week 78

Time frame:week 0, week 78

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free Fatty Acid at Week 26

Time frame:week 0, week 26

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Free Fatty Acid, Weeks 26-78

Time frame:week 26, week 78

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Free Fatty Acid at Week 78

Time frame:week 0, week 78

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Apolipoprotein B at Week 26

Time frame:week 0, week 26

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Apolipoprotein B, Weeks 26-78

Time frame:week 26, week 78

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Apolipoprotein B at Week 78

Time frame:week 0, week 78

ApoB, change

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Hypoglycaemic Episodes at Week 26

Time frame:weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide -> Liraglutide -> LiraglutideMajor	0	—
Minor	208	—
Symptoms only	79	—
Exenatide -> Liraglutide -> LiraglutideMajor	2	—
Minor	264	—
Symptoms only	93	—

Secondary/registry result

Hypoglyceamic Episodes, Weeks 26-78

Time frame:weeks 26-78

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide -> Liraglutide -> LiraglutideMajor	1	—
Minor	140	—
Symptoms only	37	—
Exenatide -> Liraglutide -> LiraglutideMajor	0	—
Minor	172	—
Symptoms only	32	—

Secondary/protocol endpoint

Hypoglycaemic Episodes at Week 26

Time frame:weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglyceamic Episodes, Weeks 26-78

Time frame:weeks 26-78

Documented hypoglycemia

event count, event

Publications (16)

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
Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials.
Journal of diabetes and its complications2014 May-Jun (year)PMID24561125doi:10.1016/j.jdiacomp.2014.01.009via 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
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
Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies.
The American journal of geriatric pharmacotherapy2011 Dec (month)PMID22055210doi:10.1016/j.amjopharm.2011.09.007via CT.gov reference
Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents.
Clinical therapeutics2011 Nov (month)PMID22018679doi:10.1016/j.clinthera.2011.09.022via CT.gov reference + pubmed nct search
Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study.
Diabetic medicine : a journal of the British Diabetic Association2011 Jun (month)PMID21388442doi:10.1111/j.1464-5491.2011.03276.xvia CT.gov reference + pubmed nct search
Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials.
The Journal of clinical endocrinology and metabolism2011 Jun (month)PMID21450987doi:10.1210/jc.2010-2822via CT.gov reference + pubmed nct search
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
Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents.
Diabetes care2010 Jun (month)PMID20332351doi:10.2337/dc09-2260via CT.gov reference + pubmed nct search
Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6).
Lancet (London, England)2009 Jul 4PMID19515413doi:10.1016/S0140-6736(09)60659-0via CT.gov reference + pubmed nct search
Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies.
Postgraduate medicine2009 May (month)PMID19491536doi:10.3810/pgm.2009.05.1998via CT.gov reference
Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.
Cardiovascular diabetology2009 Feb 26PMID19245711doi:10.1186/1475-2840-8-12via 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.