baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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