drugset / Trial / NCT01353469

Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy

NCT01353469

Phase 3 Completed 485 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2011-05
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic Subcutaneous