Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine (PORTAL 1)

NCT00964574 Phase 4 COMPLETED

Primary Objective: To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients Secondary Objective: To evaluate the insulin glulisine doses To assess the patient satisfaction

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	68
Start date	2009-07
Completion	2010-07

Conditions

• Diabetes Mellitus, Type 1

Interventions

• INSULIN GLULISINE (HMR1964)
• INSULIN GLARGINE

Primary outcomes

• Mean change in Glycosylated haemoglobin (HbA1c) — Week 12

Countries

Belarus