Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
Overview
- Phase
- Phase 4
- Intervention
- INSULIN GLARGINE
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Sanofi
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Change in HbA1c level for patients with addition of glulisine at week 12
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Primary Objective:
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).
Secondary Objectives:
- Percentage of patients with HbA1c < 7% at week 24.
- Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.
- Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
- Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
- Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
- Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.
Detailed Description
The study is divided in 3 periods: 1. a 2-week run-in period, 2. a 12-week treatment period 1 3. a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intensive insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
Intervention: INSULIN GLARGINE
Intensive insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
Intervention: INSULIN GLULISINE
insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c \<7% at week 12 (end of treatment period 1)
Intervention: INSULIN GLARGINE
Outcomes
Primary Outcomes
Change in HbA1c level for patients with addition of glulisine at week 12
Time Frame: between week 12 and week 24 (end of treatment period)
Secondary Outcomes
- Percentage of patients with HbA1c level < 7%(at week 24 (end of treatment period))
- Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event(at week 24 (end of treatment period))
- Fasting Plasma Glucose(at week 0, week 12 and week 24)
- 7-point Self Monitoring of Blood Glucose(at week 0, week 12 and week 24)
- Daily dose of insulin glargine(at week 24 (end of treatment period))
- Daily dose of insulin glulisine(at week 24 (end of treatment period))
- Systolic / diastolic blood pressure, heart rate, weight change(from week 0 (baseline) to week 24 (end of treatment period))
- Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)(from week 0 (from baseline) to week 24 (end of treatment))