Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02027753
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea
Secondary Objectives:
1. To assess the efficacy by adding insulin glargine
2. To assess insulin dose
3. Safety
- Detailed Description
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin glargine and Oral anti diabetic treatment(s) INSULIN GLARGINE 1. Insulin glargine: Lantus * Add basal insulin: starting with 0.2 U/kg/day or 10 U/day * Adjust insulin glargine dose according to Fasting blood glucose 2. Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion. Insulin glargine and Oral anti diabetic treatment(s) DPP-4 inhibitor 1. Insulin glargine: Lantus * Add basal insulin: starting with 0.2 U/kg/day or 10 U/day * Adjust insulin glargine dose according to Fasting blood glucose 2. Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion. Insulin glargine and Oral anti diabetic treatment(s) Sulphonylurea 1. Insulin glargine: Lantus * Add basal insulin: starting with 0.2 U/kg/day or 10 U/day * Adjust insulin glargine dose according to Fasting blood glucose 2. Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion. Insulin glargine and Oral anti diabetic treatment(s) Metformin 1. Insulin glargine: Lantus * Add basal insulin: starting with 0.2 U/kg/day or 10 U/day * Adjust insulin glargine dose according to Fasting blood glucose 2. Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
- Primary Outcome Measures
Name Time Method Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy week 24 (6 months)
- Secondary Outcome Measures
Name Time Method Percentage of patients with HbA1c ≤7% week 12 (3 months) Change from baseline in HbA1c week 12 (3 months), week 24 (6 months) Percentage of patients with HbA1c ≤6.5% week 12 (3 months), week 24 (6 months) Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose week 12 (3 months), week 24 (6 months) Total daily insulin dose week 24 (6 months) Fasting blood glucose (FBG) values During 3 consecutive days before baseline, week 12, Week 24 7-point Self Monitoring of Blood Glucose During 2 days within 7 days before baseline, week 12, week 24 Weight change from baseline week 24 (6 months) Number of Patients with Hypoglycemic Events up to 6 months Number of Patients with Adverse Events up to 6 months
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇰🇷Seoul, Korea, Republic of