Type 2 Diabetes
Conditions
Keywords
rivoglitazone HCl, pioglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPAR gamma), type 2 diabetes mellitus
Brief summary
The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
Interventions
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
DRUGpioglitazone HCl
30 mg capsules once daily for 12 weeks
DRUGplacebo
matching tablets or capsule once daily for 12 weeks
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * HbA1c \>6.5% and \<10.0% * FPG \>126 mg/dL (7 mmol/L) and \< 270 mg/dL (15 mmol/L)
Exclusion criteria
* History of type 1 diabetes * History of ketoacidosis * Current insulin therapy * C-peptide \<0.5ng/mL * Imparied hepatic function * NYHA Class II-IV cardiac status or hospitalization for CHF or EF\<40% * uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl | 12 weeks |
Countries
China
Outcome results
None listed