Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01212913
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.
Secondary Objective:
To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1: Basal plus INSULIN GLULISINE Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG) group 1: Basal plus INSULIN GLARGINE Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG) group 2: Biphasic insulin Insulin aspart Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL \< Pre-meal blood glucose (dinner and breakfast).
- Primary Outcome Measures
Name Time Method Change in hemoglobin A1c level (HbA1c) At 6 months of treatment
- Secondary Outcome Measures
Name Time Method Rate of hypoglycemic events (total, severe, nocturnal) from baseline to the study endpoint (over 6 months of treatment) Proportion of patients with HbA1c < 7% from baseline to the study endpoint (over 6 months of treatment) Change in body weight from baseline to the study endpoint (over 6 months of treatment) Reactive Oxidative Stress (ROS) level changes from baseline to the study endpoint (over 6 months of treatment) Change in Quality of Life from baseline to the study endpoint (over 6 months of treatment) Continuous Glucose Monitoring System (CGMS) data at baseline, 3 and 6 months
Trial Locations
- Locations (1)
Administrative Office
🇰🇷Seoul, Korea, Republic of