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)

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin human/Insuman Comb 25 (HR1799); Drug: Insulin human/Novolin® 30R

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 485
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Investigational Site Number 156001
  • Beijing, China, 100088
    • Investigational Site Number 156024
  • Beijing, China, 100730
    • Investigational Site Number 156010
  • Changchun, China, 130011
    • Investigational Site Number 156033
  • Changchun, China, 130041
    • Investigational Site Number 156017
  • Changsha, China, 410008
    • Investigational Site Number 156005
  • Chengdu, China, 610072
    • Investigational Site Number 156021
  • Chongqing, China, 400016
    • Investigational Site Number 156006
  • Hangzhou, China, 310013
    • Investigational Site Number 156032
  • Harbin, China, 150001
    • Investigational Site Number 156007
  • Hefei, China, 230001
    • Investigational Site Number 156020
  • Nanjing, China, 210006
    • Investigational Site Number 156016
  • Nanjing, China, 210011
    • Investigational Site Number 156018
  • Shanghai, China, 200003
    • Investigational Site Number 156002
  • Shanghai, China, 200040
    • Investigational Site Number 156023
  • Shanghai, China, 200062
    • Investigational Site Number 156031
  • Shanghai, China, 200065
    • Investigational Site Number 156004
  • Shenyang, China, 110022
    • Investigational Site Number 156027
  • Suzhou, China, 215004
    • Investigational Site Number 156029
  • Tianjin, China, 300052
    • Investigational Site Number 156025
  • Wuhan, China, 430022
    • Investigational Site Number 156003
  • Xi'An, China, 710032
    • Investigational Site Number 156008
  • Xi'An, China, 710061
    • Investigational Site Number 156009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insuman Comb 25; 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.	Drug: Insulin human/Insuman Comb 25 (HR1799); Pharmaceutical form:Suspension Route of administration: Subcutaneous
Active Comparator: Novolin® 30R; 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	Drug: Insulin human/Novolin® 30R; Pharmaceutical form:Suspension Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline to the end of treatment	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting plasma glucose from baseline to the end of treatment	24 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 12, 2011
• First Posted (Estimate): May 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 27, 2013
• Last Update Submitted That Met QC Criteria: February 26, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: EFC12059; U1111-1120-0701 (Other Identifier: UTN)