MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion criteria

Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

Treatment and study plan

sitagliptin phosphate

Drug

Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.

Other names: Januvia

Comparator: placebo

Drug

placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18

Time frame: Baseline and Week 18

A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18

Time frame: Baseline and Week 18

Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18

Time frame: Baseline and Week 18

Change from baseline at Week 18 is defined as Week 18 minus Week 0.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Feb 10, 2006
Registry last updated: Jun 15, 2015

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