Phase 3
Completed N=929
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00614120 ↗Enrolled (actual)
929
Serious AEs
2.2%
Results posted
Mar 2010
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) — -1.0; -1.3; -1.4; -1.3 percentage point of total HbA1c — p=<0.0001
Summary
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) |
-1.0; -1.3; -1.4; -1.3 | <0.0001 sig |
| SECONDARY Change in Body Weight |
-1.8; -2.3; -2.4; 0.1 | — |
| SECONDARY Change in Self-measured Fasting Plasma Glucose |
-1.83; -1.96; -2.28; -2.13 | — |
| SECONDARY 7-point Self-measured Plasma Glucose Profiles |
168.2; 167.5; 168.8; 163.8; 245.9; 248.0 | — |
| SECONDARY Change in Beta-cell Function |
15.3; 17.8; 21.7; 21.8 | — |
| SECONDARY Change in Fasting Lipid Profile |
0.06; -0.01; -0.03; 0.02; 0.06; -0.03 | — |
| SECONDARY Change in Fasting Lipid Profile, APO-B |
0.02; 0.00; -0.00; 0.01 | — |
| SECONDARY Hypoglycaemic Episodes |
0; 0; 0; 2; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
- HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
- HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
- BMI less than 45.0 kg/m^2
Exclusion Criteria
- Treatment with insulin within the last 3 months prior to the trial
- Impaired liver or/and renal function
- Significant cardiovascular disease over the last 6 months
- Known retinopathy or maculopathy
- Recurrent major hypoglycaemia or hypoglycaemic unawareness
Data sourced from ClinicalTrials.gov (NCT00614120). 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.