Type 2 Diabetes
Conditions
Keywords
Placebo and active control dose response study of rivoglitazone in type 2 diabetics
Brief summary
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.
Interventions
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes in male or female patients * Between 18 and 75 years of age * With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization
Exclusion criteria
* Type 1 diabetics or type 2 diabetics currently on insulin therapy * Patients unwilling or unable to discontinue their anti-diabetic medication(s) * History of ketoacidosis * History of therapy with rosiglitazone, troglitazone, pioglitazone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG, Lipids, hsCRP, Adiponectin | — |
Countries
United States
Outcome results
None listed