A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Rosiglitazone 4 mg (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Beijing 100853, China
GSK Clinical Trials Call Center, Tianjin 300052, China
GSK Clinical Trials Call Center, Beijing 100034, China
GSK Clinical Trials Call Center, Beijing 100730, China
GSK Clinical Trials Call Center, Shanghai 200025, China
GSK Clinical Trials Call Center, Shanghai 200032, China
GSK Clinical Trials Call Center, Xi'an 710032, China
GSK Clinical Trials Call Center, Shanghai 200233, China
GSK Clinical Trials Call Center, Beijing 100029, China
Additional Information
Starting date: September 2005
Last updated: July 11, 2007
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