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

This study has been completed.

First Received: July 6, 2006 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00349427

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Rosiglitazone 4 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)

Secondary Outcome Measures:

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

Estimated Enrollment:	256
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349427

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AVD102209
Study First Received:	July 6, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00349427 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

BRL49653 /rosiglitazone
Type 2 Diabetes Mellitus
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010