Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Type 2 diabetes for at least 6 months

• Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit

• 7.0 < HbA1c < 11 %

• Fasting serum C-peptide > 0.33 nmol/L

• BMI < 30 kg/m²

• Patients who is willing to monitor BG using SMBG

Exclusion Criteria:

• Type 1 Diabetes

• Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range

• Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females

• Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)

• History of alcohol or other substance abuse

• Pregnancy or not using contraceptive in childbearing aged women

• Breast feeding women

• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure

• Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

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