Phase 3
Completed N=988
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00856986 ↗Enrolled (actual)
988
Serious AEs
9.6%
Results posted
May 2011
Primary outcomePrimary: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. — 0.02; -0.51 Percentage point of total HbA1c
Summary
This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. |
0.02; -0.51 | — |
| SECONDARY Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) |
-0.1; -0.51 | — |
| SECONDARY Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) |
0.01; -0.5 | — |
| SECONDARY Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 |
-0.39; -2.12 | — |
| SECONDARY Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 |
-0.14; -1.91 | — |
| SECONDARY Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 |
-0.97; -2.09; -0.83; -1.43; -0.48; -1.18 | — |
| SECONDARY Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 |
-0.68; -2.43; -0.51; -1.14; -0.96; -1.4 | — |
| SECONDARY Mean Change From Randomisation in Fasting Insulin at Week 26 |
— | — |
| SECONDARY Mean Change From Randomisation in Fasting Insulin at Week 52 |
— | — |
| SECONDARY Mean Change From Randomisation in Fasting Pro-insulin at Week 26. |
-1.12; -9.78 | — |
| SECONDARY Mean Change From Randomisation in Fasting Pro-insulin at Week 52 |
1.47; -4 | — |
| SECONDARY Mean Change From Randomisation in Fasting C-peptide at Week 26. |
-0.08; -0.32 | — |
| SECONDARY Mean Change From Randomisation in Fasting C-peptide at Week 52. |
0.02; -0.34 | — |
| SECONDARY Mean Changes From Randomisation in Cholesterol Lipids at Week 26. |
0.04; 0.05; -0.04; -0.03; 0.05; 0.01 | — |
| SECONDARY Mean Changes From Randomisation in Cholesterol Lipids at Week 52. |
-0.02; -0.03; -0.08; -0.1; 0.03; -0.03 | — |
| SECONDARY Mean Change From Randomisation in Lipids: Triglycerides at Week 26 |
-0.24; -0.33 | — |
| SECONDARY Mean Change From Randomisation in Lipids: Triglycerides at Week 52 |
-0.22; -0.37 | — |
| SECONDARY Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 |
-0.03; -0.11 | — |
| SECONDARY Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 |
-0.03; -0.07 | — |
| SECONDARY Mean Change From Randomisation in Body Weight at Week 26 |
-0.95; -0.16 | — |
| SECONDARY Mean Change From Randomisation in Body Weight at Week 52 |
-1.02; -0.05 | — |
| SECONDARY Mean Change From Randomisation in Waist Circumference at Week 26. |
-0.66; -0.78 | — |
| SECONDARY Mean Change From Randomisation in Waist Circumference at Week 52. |
-0.83; -0.83 | — |
| SECONDARY Mean Change From Randomisation in Hip Circumference at Week 26 |
-0.36; -0.38 | — |
| SECONDARY Mean Change From Randomisation in Hip Circumference at Week 52 |
-0.79; -0.28 | — |
| SECONDARY Mean Change From Randomisation in Waist to Hip Ratio at Week 26 |
-0.00356; -0.00332 | — |
| SECONDARY Mean Change From Randomisation in Waist to Hip Ratio at Week 52 |
-0.00146; -0.00438 | — |
| SECONDARY Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. |
1.11; 0.41; -1.1; -0.4 | — |
| SECONDARY Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. |
-0.74; 0.16; -0.66; 0.11 | — |
| SECONDARY Adverse Events From Run-in (Week -12) to Week 52 |
716; 845; 2389; 383; 30 | — |
| SECONDARY Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 |
0; 0; 0; 2; 22; 31 | — |
| SECONDARY Hypoglycaemic Episodes Weeks 0-52 |
0; 0; 0; 0; 4; 33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00856986). 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.