DOMME Dose Optimization Multicentric Mexican Evaluation (DOMME)
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentric, Open Label Clinical Trial. Use of Optimal Method to Initiate and Maintain Lantus Therapy (Insulin Glargine) in Combination With Hypoglycemic Agents, Assessing the Resulting Metabolic Control and the Safety in T2 Diabetes Mellitus Patients.|
- Change in the initial vs. final values of HbA1c [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Number of severe hypoglycemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- - Change in the fasting glucose values with each visit [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- - Incidences of symptomatic and asymptomatic nocturnal hypoglycemia - Evaluations of safety with regards to the use of insulin glargine, recording the adverse events, excluding hypoglycemia - Abnormal laboratory results [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- - Change in body weight initial visit vs. final visit [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Drug: Insulin glargine
Patients will begin with a fixed, subcutaneous dose of insulin glargine, (10 U), in its commercial presentation, which will be adjusted week by week, according to the values of the glycemia when fasting (FBG), adding 2, 4, 6 or 8 units of insulin glargine over the following twelve weeks, during which the therapeutic objective should be attained, namely the glucose goal during fasting of 100 mg/dl (<6.0 mmol/L), and the active treatment is to be continued for three more months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488527
|Study Director:||Jesus Ruiz, MD||Sanofi|