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Completed

NCT Number: NCT00349427

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rosiglitazone 4 mg

Drug

Other names: Insulin

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
First posted
Jul 7, 2006
Registry last updated
Jun 4, 2012

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.

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