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

Phase 3

Completed

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

• Registration Number: NCT01353469
• Lead Sponsor: Sanofi

Brief 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

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insuman Comb 25	Insulin human/Insuman Comb 25 (HR1799)	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.
Novolin® 30R	Insulin human/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

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to the end of treatment	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose from baseline to the end of treatment	24 weeks

Trial Locations

Locations (23)

Investigational Site Number 156029; 🇨🇳 Suzhou, China

Investigational Site Number 156010; 🇨🇳 Beijing, China

Investigational Site Number 156006; 🇨🇳 Chongqing, China

Investigational Site Number 156001; 🇨🇳 Beijing, China

Investigational Site Number 156021; 🇨🇳 Chengdu, China

Investigational Site Number 156008; 🇨🇳 Xi'An, China

Investigational Site Number 156033; 🇨🇳 Changchun, China

Investigational Site Number 156005; 🇨🇳 Changsha, China

Investigational Site Number 156017; 🇨🇳 Changchun, China

Investigational Site Number 156024; 🇨🇳 Beijing, China

Investigational Site Number 156007; 🇨🇳 Harbin, China

Investigational Site Number 156023; 🇨🇳 Shanghai, China

Investigational Site Number 156032; 🇨🇳 Hangzhou, China

Investigational Site Number 156020; 🇨🇳 Hefei, China

Investigational Site Number 156002; 🇨🇳 Shanghai, China

Investigational Site Number 156031; 🇨🇳 Shanghai, China

Investigational Site Number 156003; 🇨🇳 Wuhan, China

Investigational Site Number 156004; 🇨🇳 Shanghai, China

Investigational Site Number 156027; 🇨🇳 Shenyang, China

Investigational Site Number 156025; 🇨🇳 Tianjin, China

Investigational Site Number 156009; 🇨🇳 Xi'An, China

Investigational Site Number 156016; 🇨🇳 Nanjing, China

Investigational Site Number 156018; 🇨🇳 Nanjing, China