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

Last updated: February 26, 2013
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Diabetes Prevention

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT01353469
EFC12059
U1111-1120-0701
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 premixinsulin therapy, with or without oral anti-diabetic drug (OAD)

  • Signed written informed consent

Exclusion

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 insulintreatment within 3 months prior to screening visit

  • In case of treatment with OAD, treatment with a stable OAD dose and regimen for lessthan 3 months prior to screening visit The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.

Study Design

Total Participants: 485
Study Start date:
May 01, 2011
Estimated Completion Date:
November 30, 2012

Study Description

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

Connect with a study center

  • Investigational Site Number 156001

    Beijing, 100853
    China

    Site Not Available

  • Investigational Site Number 156010

    Beijing, 100730
    China

    Site Not Available

  • Investigational Site Number 156024

    Beijing, 100088
    China

    Site Not Available

  • Investigational Site Number 156017

    Changchun, 130041
    China

    Site Not Available

  • Investigational Site Number 156033

    Changchun, 130011
    China

    Site Not Available

  • Investigational Site Number 156005

    Changsha, 410008
    China

    Site Not Available

  • Investigational Site Number 156021

    Chengdu, 610072
    China

    Site Not Available

  • Investigational Site Number 156006

    Chongqing, 400016
    China

    Site Not Available

  • Investigational Site Number 156032

    Hangzhou, 310013
    China

    Site Not Available

  • Investigational Site Number 156007

    Harbin, 150001
    China

    Site Not Available

  • Investigational Site Number 156020

    Hefei, 230001
    China

    Site Not Available

  • Investigational Site Number 156016

    Nanjing, 210006
    China

    Site Not Available

  • Investigational Site Number 156018

    Nanjing, 210011
    China

    Site Not Available

  • Investigational Site Number 156002

    Shanghai, 200003
    China

    Site Not Available

  • Investigational Site Number 156004

    Shanghai, 200065
    China

    Site Not Available

  • Investigational Site Number 156023

    Shanghai, 200040
    China

    Site Not Available

  • Investigational Site Number 156031

    Shanghai, 200062
    China

    Site Not Available

  • Investigational Site Number 156027

    Shenyang, 110022
    China

    Site Not Available

  • Investigational Site Number 156029

    Suzhou, 215004
    China

    Site Not Available

  • Investigational Site Number 156025

    Tianjin, 300052
    China

    Site Not Available

  • Investigational Site Number 156003

    Wuhan, 430022
    China

    Site Not Available

  • Investigational Site Number 156008

    Xi'An, 710032
    China

    Site Not Available

  • Investigational Site Number 156009

    Xi'An, 710061
    China

    Site Not Available

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