Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
Completed
Sanofi
Phase 4
2010-12-01
Primary Objective:
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin
glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week
24 (visit 10).
Secondary Objectives:
1. Percentage of patients with HbA1c < 7% at week 24.
2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event
at week 24.
3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week
0, week 12 and week 24.
4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose /
kg (U/kg) will be calculated at week 24.
5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at
week 0, week 12 and week 24.
6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal
symptomatic, severe and nocturnal severe) will be evaluated during the treatment period.
7-Adverse events.
baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Completed
Sanofi
Phase 4
2010-11-01
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
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