Insulin Glargine Combination Therapies in Type II Diabetics

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human; Metformin

Criteria

Inclusion Criteria:

• Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)

• HbA1c value ≥ 7.5 % to ≤ 10.5 %

• FBG ≥ 120 mg/dl (6.6 mmol/l)

• BMI ≤ 35 kg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.