A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

May 31, 2012 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • GSK Investigational Site
      • Beijing, China, 100029
        • GSK Investigational Site
      • Beijing, China, 100730
        • GSK Investigational Site
      • Beijing, China, 100853
        • GSK Investigational Site
      • Shanghai, China, 200032
        • GSK Investigational Site
      • Shanghai, China, 200001
        • GSK Investigational Site
      • Shanghai, China, 200233
        • GSK Investigational Site
      • Tianjin, China, 300052
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • GSK Investigational Site
    • Shanxi
      • Xian, Shanxi, China, 710032
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
  • If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level>7.5%.

Exclusion:

  • Fasting plasma glucose >13 mmol/L at screening
  • Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
  • Drug abuse
  • Women pregnant or lactating
  • Use any rosiglitazone like drug in 3 months
  • Use more than one oral antidiabetic agent in 2 months
  • Uncontrolled hypertension
  • Chronic heart failure
  • Anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosiglitazone
4mg
Drug: Rosiglitazone 4 mg
Other Names:
  • Insulin
Placebo Comparator: Rosiglitazone placebo
4mg
Drug: Rosiglitazone 4 mg
Other Names:
  • Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks
Time Frame: 8, 16, and 24 weeks
8, 16, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 7, 2006

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVD102209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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