Status:
COMPLETED
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 efficacio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00349427
Start Date
October 1 2005
Last Update
June 4 2012
Active Locations (10)
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1
GSK Investigational Site
Nanjing, Jiangsu, China, 210008
2
GSK Investigational Site
Xian, Shanxi, China, 710032
3
GSK Investigational Site
Beijing, China, 100029
4
GSK Investigational Site
Beijing, China, 100034