Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)

Secondary objective:

Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs

• 7.5 ≤ HbA1c ≤ 9.5%

• FPG ≥6.7 mmol/L

• History of Diabetes mellitus ≤10 years

• Premix insulin daily dosage ≤ 50 IU/Day

Exclusion Criteria:

• Type 1 Diabetes Mellitus

• Former treated on TZD

• Pregnancy / Lactation

• Creatine ≥1.5 mg/dl

• Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range

• Hormone therapy,

• Acute status of Diabetes complications

• Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.

• Allergic to insulin glargine or any ingredient

• Participation in another clinical trial within 3 months

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