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

Type 2 Diabetes Mellitus Clinical Trial

— Insuman-C25-CN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353469
• Other study ID #: EFC12059
• Secondary ID: U1111-1120-0701
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2011
• Last updated: February 26, 2013
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin human/Insuman Comb 25 (HR1799)
Pharmaceutical form:Suspension Route of administration: Subcutaneous
• Insulin human/Novolin® 30R
Pharmaceutical form:Suspension Route of administration: Subcutaneous

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156010	Beijing
China	Investigational Site Number 156024	Beijing
China	Investigational Site Number 156017	Changchun
China	Investigational Site Number 156033	Changchun
China	Investigational Site Number 156005	Changsha
China	Investigational Site Number 156021	Chengdu
China	Investigational Site Number 156006	Chongqing
China	Investigational Site Number 156032	Hangzhou
China	Investigational Site Number 156007	Harbin
China	Investigational Site Number 156020	Hefei
China	Investigational Site Number 156016	Nanjing
China	Investigational Site Number 156018	Nanjing
China	Investigational Site Number 156002	Shanghai
China	Investigational Site Number 156004	Shanghai
China	Investigational Site Number 156023	Shanghai
China	Investigational Site Number 156031	Shanghai
China	Investigational Site Number 156027	Shenyang
China	Investigational Site Number 156029	Suzhou
China	Investigational Site Number 156025	Tianjin
China	Investigational Site Number 156003	Wuhan
China	Investigational Site Number 156008	Xi'An
China	Investigational Site Number 156009	Xi'An

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to the end of treatment		24 weeks	No
Secondary	Change in fasting plasma glucose from baseline to the end of treatment		24 weeks	No