Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Phase 4
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: INSULIN GLARGINE HOE 901
- Registration Number
- NCT01461577
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.
Secondary Objective:
* To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
- Detailed Description
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description insulin glargine INSULIN GLARGINE HOE 901 Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm
- Primary Outcome Measures
Name Time Method Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline 24 weeks
- Secondary Outcome Measures
Name Time Method Weight change from baseline 24 weeks Responder rate (HbA1c levels <7%) without severe hypoglycemia 24 weeks Responder rate (HbA1c levels <6.5% and <7%) 24 weeks Changes of fasting plasma glucose (FPG) levels from baseline 24 weeks Changes of beta cell marker: C-peptide from baseline 24 weeks Changes of Lipid profile: Lipid profile from baseline 24 weeks Total insulin dose (per kg body weight) 24 weeks Evaluation of patient's treatment satisfaction 24 weeks Number of patients with hypoglycemia up to 24 weeks Number of patients with treatment-emergent adverse events up to 24 weeks
Trial Locations
- Locations (1)
Administrative office
🇯🇵Tokyo, Japan