baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

Summary

Primary Objective: To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM). Secondary Objectives: To evaluate: * The change of hemoglobin A1c (HbA1c) from baseline to week 12 * The percentage of patients with HbA1c \< 7% at week 12 and week 24 * The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24 * The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24 * The incidence of symptomatic hypoglycemias * Adverse events

Timeline

Start

2010-11

Primary completion

2013-01

Completion

2013-01

Drugs

Indications