Study of Rivoglitazone in Type 2 Diabetes Mellitus

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Pioglitazone; Drug: Rivoglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00484198

CS0011-A-U301

2006-005047-28 (EudraCT Number)

Details and patient eligibility

About

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Enrollment: 1,912 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes
• Male or female at least 18 years of age
• Hemoglobin A1C > 7% and less or equal to 8.5%
• Non-fasting C-peptide > 0.5 ng/mL
• Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or
• Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion criteria

• History of type 1 diabetes or ketoacidosis
• History of long-term therapy with insulin
• Body Mass Index (BMI) > 45 kg/m^2
• Known history of Congestive Heart Failure (CHF)
• Impaired hepatic function
• History of prior treatment failure with, or intolerance of, a TZD
• Contraindication to treatment with pioglitazone
• Treatment with fibrates
• If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,912 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Description:

Rivoglitazone 1.0 mg

Treatment:

Drug: Rivoglitazone

Drug: Rivoglitazone

3

Experimental group

Description:

Rivoglitazone 1.5 mg

Treatment:

Drug: Rivoglitazone

Drug: Rivoglitazone

4

Active Comparator group

Description:

Pioglitazone 45 mg

Treatment:

Drug: Pioglitazone