Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion criteria:

- Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO),
diagnosed for at least 1 year at the time of screening visit who are under premix
insulin therapy, with or without oral anti-diabetic drug (OAD)

- Signed written informed consent

Exclusion criteria:

- HbA1c <7% or HbA1c >10% at screening

- No self-monitoring of blood glucose within 3 months prior to screening visit

- Premix insulin treatment for less than 3 months. Insulins other than premix insulin
treatment within 3 months prior to screening visit

- In case of treatment with OAD, treatment with a stable OAD dose and regimen for less
than 3 months prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.