Diabetes Mellitus, Type 2 Clinical Trial
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.
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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