A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients - Full Text View

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 Diabetes Mellitus, Type 2	Drug: Rosiglitazone 4 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef 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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 8, 16, and 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	256
Study Start Date:	October 2005

Arms	Assigned Interventions
Experimental: Rosiglitazone 4mg	Drug: Rosiglitazone 4 mg Other Name: Insulin
Placebo Comparator: Rosiglitazone placebo 4mg	Drug: Rosiglitazone 4 mg Other Name: Insulin

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00349427 History of Changes
Other Study ID Numbers:	AVD102209
Study First Received:	July 6, 2006
Last Updated:	December 9, 2010
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Insulin
BRL49653 /rosiglitazone
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:

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

Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012