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Completed

NCT Number: NCT00363519

Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku Region, Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion criteria

  • Patients with Type 1 diabetes mellitus

Treatment and study plan

Placebo

Drug

Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

sitagliptin phosphate

Drug

Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

Primary outcomes

  1. HbA1c

    Time frame: 12 weeks

  2. safety

    Time frame: 52 weeks

  3. tolerability

    Time frame: 52 weeks

Secondary outcomes

  1. Plasma glucose

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride add-on Study for Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2006
Primary completion
2008
First posted
Aug 15, 2006
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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