NCT01461577
Completed
Phase 4
A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
ConditionsType 2 Diabetes Mellitus
InterventionsINSULIN GLARGINE HOE 901
Overview
- Phase
- Phase 4
- Intervention
- INSULIN GLARGINE HOE 901
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
insulin glargine
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
Intervention: INSULIN GLARGINE HOE 901
Outcomes
Primary Outcomes
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Time Frame: 24 weeks
Secondary Outcomes
- Responder rate (HbA1c levels <6.5% and <7%)(24 weeks)
- Weight change from baseline(24 weeks)
- Responder rate (HbA1c levels <7%) without severe hypoglycemia(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)
Study Sites (1)
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