Phase 3
Completed N=665
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00700817 ↗Enrolled (actual)
665
Serious AEs
7.3%
Results posted
Aug 2010
Primary outcomePrimary: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 — -1.24; -1.5; -0.9 Percentage point of total HbA1c — p=0.0001
Summary
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.
The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
1. Week 27-52 after randomisation
- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation
* Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
* Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 |
-1.24; -1.5; -0.9 | 0.0001 sig |
| PRIMARY Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 |
-1.29; -1.51; -0.88 | 0.0001 sig |
| PRIMARY Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 |
-0.94; -1.28 | — |
| PRIMARY Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 |
-0.24; -0.45 | 0.0060 sig |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 |
43; 55; 22 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 |
50; 63; 27 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 |
49; 50 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 |
23; 36; 12 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 |
24; 40; 17 | — |
| SECONDARY Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 |
29; 25 | — |
| SECONDARY Mean Change From Baseline in Body Weight at Week 26 |
-2.86; -3.38; -0.96 | — |
| SECONDARY Mean Change From Baseline in Body Weight at Week 52 |
-2.78; -3.68; -1.16 | — |
| SECONDARY Mean Change in Body Weight From Week 52 to Week 78 |
-1.64; -2.48 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-1.87; -2.14; -0.83 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
-1.71; -2.04; -0.59 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 |
-1.30; -1.65 | — |
| SECONDARY Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 |
-0.84; -1.42 | — |
| SECONDARY Mean Change From Baseline in Beta-cell Function at Week 26 |
27.23; 28.70; 4.18 | — |
| SECONDARY Mean Change From Baseline in Beta-cell Function at Week 52 |
22.58; 25.76; 3.98 | — |
| SECONDARY Mean Change in Beta-cell Function From Week 52 to Week 78 |
13.31; 23.09 | — |
| SECONDARY Mean Change From Baseline in Total Cholesterol at Week 26 |
-0.03; -0.17; -0.02 | — |
| SECONDARY Mean Change From Baseline in Total Cholesterol at Week 52 |
-0.01; -0.09; 0.03 | — |
| SECONDARY Mean Change in Total Cholesterol From Week 52 to Week 78 |
-0.16; -0.24 | — |
| SECONDARY Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 |
0.08; 0.05; 0.13 | — |
| SECONDARY Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 |
0.09; 0.09; 0.17 | — |
| SECONDARY Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 |
-0.22; -0.25 | — |
| SECONDARY Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 |
0.00; 0.00; 0.00 | — |
| SECONDARY Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 |
0.01; 0.02; 0.01 | — |
| SECONDARY Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 |
0.02; -0.01 | — |
| SECONDARY Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 |
-0.11; -0.20; -0.15 | — |
| SECONDARY Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 |
-0.11; -0.19; -0.15 | — |
| SECONDARY Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 |
0.03; 0.02 | — |
| SECONDARY Mean Change From Baseline in Triglycerides (TG) at Week 26 |
-0.19; -0.43; -0.40 | — |
| SECONDARY Mean Change From Baseline in Triglycerides (TG) at Week 52 |
-0.10; -0.32; -0.23 | — |
| SECONDARY Mean Change in Triglycerides (TG) From Week 52 to Week 78 |
-0.20; -0.26 | — |
| SECONDARY Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 |
-0.03; -0.07; -0.05 | — |
| SECONDARY Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 |
-0.07; -0.10; -0.06 | — |
| SECONDARY Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 |
0.02; -0.01 | — |
| SECONDARY Mean Change From Baseline in Apolipoprotein B at Week 26 |
-0.06; -0.07; -0.05 | — |
| SECONDARY Mean Change From Baseline in Apolipoprotein B at Week 52 |
-0.03; -0.03; -0.03 | — |
| SECONDARY Mean Change in Apolipoprotein B From Week 52 to Week 78 |
0.23; 0.17 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 |
-1.02; -0.99; -0.66 | — |
| SECONDARY Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. |
-833; -561; 586 | — |
| SECONDARY Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. |
-1.70; 1.71; 0.91 | — |
| SECONDARY Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. |
5.19; 3.74; 3.71 | — |
| SECONDARY Mean Change From Baseline in Adiponectin at Week 26. |
1.69; 1.51; 1.35 | — |
| SECONDARY Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. |
-0.55; -0.74; -0.53 | — |
| SECONDARY Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. |
-1.73; -4.34; -1.8 | — |
| SECONDARY Mean Change From Baseline in Waist to Hip Ratio at Week 26. |
-0.01; -0.01; -0.00 | — |
| SECONDARY Mean Change From Baseline in Waist to Hip Ratio at Week 52 |
-0.00; -0.01; -0.00 | — |
| SECONDARY Mean Change in Waist to Hip Ratio From Week 52 to Week 78 |
-0.01; -0.00 | — |
| SECONDARY Mean Change From Baseline in Waist Circumference at Week 26. |
-2.69; -2.63; -1.12 | — |
| SECONDARY Mean Change From Baseline in Waist Circumference at Week 52 |
-2.36; -3.02; -1.23 | — |
| SECONDARY Mean Change in Waist Circumference From Week 52 to Week 78 |
-1.33; -2.05 | — |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 |
-0.55; -0.72; -0.94 | — |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 |
-0.37; -2.55; -1.03 | — |
| SECONDARY Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 |
-2.12; 0.35 | — |
| SECONDARY Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 |
-0.71; 0.07; -1.78 | — |
| SECONDARY Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 |
-0.53; -0.87; -1.47 | — |
| SECONDARY Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 |
-0.60; 0.03 | — |
| SECONDARY Mean Change From Baseline in Pulse at Week 26 |
2.32; 3.94; -0.64 | — |
| SECONDARY Mean Change From Baseline in Pulse at Week 52 |
1.72; 3.09; 0.09 | — |
| SECONDARY Mean Change in Pulse From Week 52 to Week 78 |
0.90; 2.19 | — |
| SECONDARY Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 |
3.51; 4.35; 2.96 | — |
| SECONDARY Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 |
3.32; 4.31; 2.96 | — |
| SECONDARY Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 |
1.48; 0.98 | — |
| SECONDARY Hypoglyceamic Episodes, Weeks 0-26 |
1; 0; 0; 17; 37; 11 | — |
| SECONDARY Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 |
1; 0; 0; 17; 16; 11 | — |
| SECONDARY Hypoglyceamic Episodes, Weeks 0-52 |
1; 0; 0; 24; 51; 25 | — |
| SECONDARY Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 |
1; 0; 0; 24; 28; 25 | — |
| SECONDARY Hypoglyceamic Episodes, Weeks 0-78 |
2; 0; 0; 36; 56; 34 | — |
| SECONDARY Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 |
2; 0; 0; 36; 33; 34 | — |
| SECONDARY Hypoglycaamic Episodes, Weeks 52-78 |
1; 0; 0; 0; 12; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00700817). 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. Informational only — not medical advice.