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Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

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Daiichi Sankyo

Status and phase

Completed
Phase 3
Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo
Drug: Pioglitazone
Drug: Rivoglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00143520
CS0011-203

Details and patient eligibility

About

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.

Enrollment

441 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

74

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Data sourced from clinicaltrials.gov

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