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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00349427
First Posted: July 7, 2006
Last Update Posted: June 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 100029
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China, 100730
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 GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00349427     History of Changes
Other Study ID Numbers: AVD102209
First Submitted: July 6, 2006
First Posted: July 7, 2006
Last Update Posted: June 4, 2012
Last Verified: February 2011

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
Insulin, Globin Zinc
Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs