drugset / Trial / NCT00488527

DOMME Dose Optimization Multicentric Mexican Evaluation

NCT00488527 ↗

Phase 4 Completed 371 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2007-04
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic 10 iu Subcutaneous