LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

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

Summary

The rationale of the study is to determine:

• the first dose and the titration of basal insulin

• the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)

• BMI >25 kg/m2 , <30 kg/m2

• HbA1c value >7.0%, <9.0% within one month

Exclusion Criteria:

• Type 1 Diabetes Mellitus

• Known malignancy

• Drug or alcohol abuse

• Severe liver disease

• Renal failure (se Creatinine > 150 micro mol/l)

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