Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen. (SUBSTITUTE)

NCT01204593 Phase 4 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	206
Start date	2010-11
Completion	2013-01

Conditions

• Diabetes Mellitus, Type 1

Interventions

• INSULIN GLARGINE
• INSULIN GLULISINE

Primary outcomes

• Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)) — between baseline (week 0) and endpoint (week 24)

Countries

Algeria, Argentina, Brazil, Colombia, Kuwait, Mexico, Saudi Arabia, South Africa, Tunisia