Study of Rivoglitazone in Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00484198

Run by

Daiichi Sankyo

People needed

1912

Starts

2007-04-23

Expected to finish

2009-02-12

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Hoover, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Buena Park, California, United States
• Study site — Garden Grove, California, United States
• Study site — Huntington Park, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — West Covina, California, United States
• Study site — West Hills, California, United States
• Study site — Denver, Colorado, United States
• Study site — Delray Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Merritt Island, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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