Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Rivoglitazone HCl; Drug: rivoglitazone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575471

CS011-A-J204

Details and patient eligibility

About

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Enrollment: 250 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes mellitus
• HbA1c >6.5% and <10%
• FPG >126 mg/dL (7mmol/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
• impaired hepatic function
• CHF or history of CHF (NYHA stage I - IV)
• uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks

Treatment:

Drug: Rivoglitazone HCl

2

Experimental group

Description:

rivoglitazone HCl 1 mg tablets once daily for 12 weeks

Treatment:

Drug: rivoglitazone HCl

Drug: rivoglitazone HCl

3

Experimental group

Description:

rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks

Treatment:

Drug: rivoglitazone HCl

Drug: rivoglitazone HCl

4

Placebo Comparator group

Description:

Matching placebo tablets once daily for 12 weeks

Treatment:

Drug: Placebo