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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349427
• Other study ID #: AVD102209
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2006
• Last updated: May 31, 2012
• Start date: October 2005

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Rosiglitazone 4 mg

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)		24 weeks	No
Secondary	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		8, 16, and 24 weeks	Yes