Phase 3
Completed N=264
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00395746 ↗Enrolled (actual)
264
Serious AEs
4.6%
Results posted
Mar 2010
Primary outcomePrimary: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment — 7.02; 6.75; 8.02 percentage of total haemoglobin — p=<0.0001
Summary
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment |
7.02; 6.75; 8.02 | <0.0001 sig |
| SECONDARY Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment |
7.42; 7.06; 8.39 | — |
| SECONDARY Fasting Plasma Glucose After 24 Weeks of Treatment |
132.2; 126.2; 158.8 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose After 52 Weeks of Treatment |
140.3; 134.5; 164.6 | — |
| SECONDARY Postprandial Glucose AUC After 24 Weeks of Treatment |
614.58; 575.50; 725.72 | <0.0001 sig |
| SECONDARY Postprandial Glucose AUC After 52 Weeks of Treatment |
648.87; 589.98; 717.55 | — |
| SECONDARY Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment |
160.20; 150.05; 194.50 | <0.0001 sig |
| SECONDARY Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment |
171.42; 159.58; 205.92 | — |
| SECONDARY Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment |
86.38; 68.34; 79.71 | 0.0433 sig |
| SECONDARY Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment |
82.28; 76.09; 89.39 | — |
| SECONDARY Body Weight After 24 Weeks of Treatment |
65.77; 65.34; 64.59 | 0.0071 sig |
| SECONDARY Body Weight After 52 Weeks of Treatment |
65.96; 65.87; 64.83 | — |
| SECONDARY Hypoglycaemic Episodes |
3.131; 3.715; 2.990; 0.0000; 0.0000; 0.0000 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks
- HbA1c greater than or equal to 7.0% and less than 10.0%
- BMI less than 35 kg/m2
Exclusion Criteria
- Treatment with insulin within the last 12 weeks
- Treatment with any drug that could interfere with the glucose level
- Any serious medical condition
- Females who are pregnant, have intention of becoming pregnant or are breastfeeding
Data sourced from ClinicalTrials.gov (NCT00395746). 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.