Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes (RAISE)

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: pioglitazone HCl; Drug: Rivoglitazone HCl; Drug: rivoglitazone HCl; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575874

CS011-A-J205

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

0.5 mg rivoglitazone HCl tablets once daily for 12 weeks

Treatment:

Drug: Rivoglitazone HCl

2

Experimental group

Description:

1.0 mg rivoglitazone HCl tablets once daily for 12 weeks

Treatment:

Drug: rivoglitazone HCl

Drug: rivoglitazone HCl

3

Experimental group

Description:

1.5 mg rivoglitazone HCl tablets once daily for 12 weeks

Treatment:

Drug: rivoglitazone HCl

Drug: rivoglitazone HCl

4

Active Comparator group

Description:

30 mg pioglitazone HCl capsules once daily for 12 weeks

Treatment:

Drug: pioglitazone HCl

5

Placebo Comparator group

Description:

Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules

Treatment:

Drug: placebo