A Multicenter, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Insuman Comb 25 (Insulin Human) Versus Novolin® 30R Twice Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus Who Are Under Insulin Therapy (Insuman-C25-CN)

NCT01353469 Phase 3 COMPLETED

Primary Objective: To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: * To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG) * To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	485
Start date	2011-05
Completion	2012-11

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Insulin human/Insuman Comb 25 (HR1799)
• Insulin human/Novolin® 30R

Primary outcomes

• Change in HbA1c from baseline to the end of treatment — 24 weeks

Countries

China