Skip to main content
OpenTrials
Completed

NCT Number: NCT01353469

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 156001, Beijing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin human/Insuman Comb 25 (HR1799)

Drug

Pharmaceutical form:Suspension

Route of administration: Subcutaneous

Insulin human/Novolin® 30R

Drug

Pharmaceutical form:Suspension

Route of administration: Subcutaneous

Primary outcomes

  1. Change in HbA1c from baseline to the end of treatment

    Time frame: 24 weeks

Secondary outcomes

  1. Change in fasting plasma glucose from baseline to the end of treatment

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: Insuman-C25-CN

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 13, 2011
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.