Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin, BRL49653 /rosiglitazone, Type 2 Diabetes Mellitus
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 efficacious in terms of improving glycemic control.
Interventions
DRUGRosiglitazone 4 mg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed