Phase 3
N=467
Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00518882 ↗Enrolled (actual)
467
Serious AEs
9.9%
Results posted
Mar 2010
Primary outcome: Primary: Change in Glycosylated A1c (HbA1c) at Week 26 — -1.12; -0.79 percentage point of total HbA1c — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- liraglutide (Drug); exenatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated A1c (HbA1c) at Week 26 |
-1.12; -0.79 | <.0001 sig |
| SECONDARY Change in Glycosylated A1c (HbA1c), Weeks 26-78 |
0.25; -0.00 | <0.0001 sig |
| SECONDARY Change in Glycosylated A1c (HbA1c) at Week 78 |
-0.98; -0.85 | <0.0001 sig |
| SECONDARY Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 |
53; 42; 34; 20 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 |
47; 48; 31; 35 | — |
| SECONDARY Change in Body Weight at Week 26 |
-3.24; -2.87 | 0.2235 |
| SECONDARY Change in Body Weight, Weeks 26-78 |
-0.4; -0.7 | 0.0793 |
| SECONDARY Change in Body Weight at Week 78 |
-3.3; -3.2 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose at Week 26 |
-1.61; -0.60 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose, Weeks 26-78 |
0.7; -0.1 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose at Week 78 |
-1.3; -0.8 | <0.0001 sig |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 |
-0.83; -2.16 | <.0001 sig |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 |
0.06; 0.06 | 0.9849 |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 |
-1.10; -2.11 | 0.0005 sig |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 |
-0.22; 1.15 | 0.2972 |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 |
0.05; -0.09 | 0.8396 |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 |
0.22; 1.07 | 0.3271 |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 |
-1.08; -0.99 | <0.0001 sig |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 |
0.26; -0.37 | 0.3859 |
| SECONDARY Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 |
-0.35; -0.95 | 0.2290 |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 |
-3.20; -3.93 | 0.0124 sig |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 |
-2.74; -2.35 | 0.1430 |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 |
-3.05; -3.59 | 0.0380 sig |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 |
0.06; 0.72 | 0.7700 |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 |
0.67; -0.09 | 0.0026 sig |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 |
0.32; 0.58 | 0.1041 |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 |
-3.31; -3.13 | <0.0001 sig |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 |
-1.93; -2.17 | <0.0001 sig |
| SECONDARY Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 |
-2.21; -2.55 | <0.0001 sig |
| SECONDARY Change in Beta-cell Function at Week 26 |
32.12; 2.74 | <.0001 sig |
| SECONDARY Change in Beta-cell Function, Weeks 26-78 |
-18.18; 2.29 | <0.0001 sig |
| SECONDARY Change in Beta-cell Function at Week 78 |
24.86; 11.13 | <0.0001 sig |
| SECONDARY Change in Total Cholesterol at Week 26 |
-0.20; -0.09 | 0.0946 |
| SECONDARY Change in Total Cholesterol, Weeks 26-78 |
0.11; 0.12 | 0.0513 |
| SECONDARY Change in Total Cholesterol at Week 78 |
-0.07; 0.09 | 0.2764 |
| SECONDARY Change in Low-density Lipoprotein-cholesterol at Week 26 |
-0.44; -0.40 | 0.4412 |
| SECONDARY Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 |
0.03; 0.08 | 0.4746 |
| SECONDARY Change in Low-density Lipoprotein-cholesterol at Week 78 |
-0.30; -0.21 | <0.0001 sig |
| SECONDARY Change in Very Low-density Lipoprotein-cholesterol at Week 26 |
0.20; 0.27 | 0.0277 sig |
| SECONDARY Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 |
0.06; 0.03 | 0.0030 sig |
| SECONDARY Change in Very Low-density Lipoprotein-cholesterol at Week 78 |
0.27; 0.31 | <0.0001 sig |
| SECONDARY Change in High-density Lipoprotein-cholesterol at Week 26 |
-0.04; -0.05 | 0.5105 |
| SECONDARY Change in High-density Lipoprotein-cholesterol, Weeks 26-78 |
-0.01; 0.00 | 0.2220 |
| SECONDARY Change in High-density Lipoprotein-cholesterol at Week 78 |
-0.03; -0.02 | 0.0254 sig |
| SECONDARY Change in Triglyceride at Week 26 |
-0.41; -0.23 | 0.0485 sig |
| SECONDARY Change in Triglyceride, Weeks 26-78 |
0.1; -0.0 | 0.1161 |
| SECONDARY Change in Triglyceride at Week 78 |
-0.3; -0.1 | 0.0003 sig |
| SECONDARY Change in Free Fatty Acid at Week 26 |
-0.17; -0.10 | 0.0014 sig |
| SECONDARY Change in Free Fatty Acid, Weeks 26-78 |
0.06; 0.01 | 0.0018 sig |
| SECONDARY Change in Free Fatty Acid at Week 78 |
-0.10; -0.07 | <0.0001 sig |
| SECONDARY Change in Apolipoprotein B at Week 26 |
-0.06; -0.03 | 0.1119 |
| SECONDARY Change in Apolipoprotein B, Weeks 26-78 |
-0.02; -0.03 | 0.1342 |
| SECONDARY Change in Apolipoprotein B at Week 78 |
-0.08; -0.07 | <0.0001 sig |
| SECONDARY Hypoglycaemic Episodes at Week 26 |
0; 2; 208; 264; 79; 93 | — |
| SECONDARY Hypoglyceamic Episodes, Weeks 26-78 |
1; 0; 140; 172; 37; 32 | — |
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00518882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.