A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

CompletadoFase 3ClinicalTrials.gov

ID: NCT00484198Tipo: INTERVENTIONALInicio: 23 de abr de 2007Fin estimado: 12 de feb de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Pioglitazone

45 mg over-encapsulated tablet administered orally, once daily

drug

Placebo

Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule

drug

Rivoglitazone

1.0 mg tablet administered orally, once daily

drug

Rivoglitazone

1.5 mg tablet administered orally, once daily

Ubicaciones

San Vicente, Córdoba Province, Argentina

Loma Verde, Buenos Aires, Argentina

Zárate, Buenos Aires, Argentina

Patrocinadores

PrincipalDaiichi Sankyo

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