MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

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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–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients have type 2 diabetes mellitus
On diet/exercise therapy

Exclusion criteria

Patients have type 1 diabetes mellitus

Treatment and study plan

MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks

Drug

Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks

Drug

Primary outcomes

HbA1c, safety and tolerability

Secondary outcomes

Plasma glucose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 1, 2006
Registry last updated: Apr 4, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed