A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents
Overview
- Phase
- Phase 4
- Intervention
- INSULIN GLARGINE
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Sanofi
- Enrollment
- 934
- Locations
- 96
- Primary Endpoint
- Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Primary Objective:
To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.
Secondary Objectives:
To assess the effect of insulin glargine in comparison with premixed insulin on :
- Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)
- Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles
- Evolution of weight
- Hypoglycemia occurrence
- Dose of insulins
- Evolution of liver function
- Overall safety
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Insulin glargine
Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision. Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11). Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12. Starting dose is of 4 units per day.
Intervention: INSULIN GLARGINE
Insulin glargine
Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision. Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11). Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12. Starting dose is of 4 units per day.
Intervention: INSULIN GLULISINE
Premixed insulin
administered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
Intervention: PREMIXED INSULIN
Outcomes
Primary Outcomes
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24)
Secondary Outcomes
- Self-monitored PG (Plasma Glucose) values over 3 consecutive days(before visit 12 (week 16))
- 7-point plasma glucose (PG) profile recorded on 3 consecutive days(From baseline (visit 2, week 0) to visit 14 (week 24))
- Insulin doses of the day before each visit(from visit 3 (week 1) to visit 14 (week 24))
- Weight and supine blood pressure(From baseline (visit 2, week 0) to visit 14 (week 24))
- Biochemistry and lipid profile(From baseline (visit 2, week 0) to visit 14 (week 24))