Overview

DOMME Dose Optimization Multicentric Mexican Evaluation

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of respondents percentage. The respondent is defined as the person achieving a value in the final determination of HbA1c < 7% as its absolute value and/or a decreasing in the final value of HbA1c of more than 12% compared with the initial value (final HbA1c vs. initial HbA1c). Describe the glycemia levels and body weight change in the two response groups, (respondents and non-respondents). Describe the adverse events Evaluate the safety of using the medication according to the incidence and relevance of the hypoglycemia events, (symptomatic, diurnal, nocturnal, severe). Estimate the intra-patient variability of the fasting glycemia
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc