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 (Insuman-C25-CN)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin human/Novolin® 30R; Drug: Insulin human/Insuman Comb 25 (HR1799)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353469

EFC12059

U1111-1120-0701 (Other Identifier)

Details and patient eligibility

About

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

Full description

The study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks open-label treatment + 1 week follow-up).

Enrollment: 485 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 2 patient groups

Insuman Comb 25

Experimental group

Description:

Insuman Comb 25 will be self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline.

Treatment:

Drug: Insulin human/Insuman Comb 25 (HR1799)

Novolin® 30R

Active Comparator group

Description:

Novolin® 30R will be self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline and the package insert of Novolin® 30R

Treatment:

Drug: Insulin human/Novolin® 30R