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Completed

NCT Number: NCT00094757

An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

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Key information

Conditions

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

Age range

18 year–75 year

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 at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion criteria

  • Younger than 18 years of age or older than 75
  • Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Treatment and study plan

Comparator: sitagliptin 100 mg

Drug

sitagliptin 100 mg oral tablet once daily for 54 weeks

Comparator: sitagliptin 200 mg

Drug

sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks

Comparator: placebo

Drug

placebo oral tablet once daily during Phase A (Weeks 0-18)

Comparator: pioglitazone

Drug

pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Primary outcomes

  1. Change From Baseline in A1C at Week 18

    Time frame: Weeks 0-18

    Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Secondary outcomes

  1. Change From Baseline in FPG at Week 18

    Time frame: Weeks 0-18

    The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.

  2. Change From Baseline in A1C at Week 54

    Time frame: Weeks 0-54

    A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

  3. Change From Baseline in FPG at Week 54

    Time frame: Weeks 0-54

    The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Oct 25, 2004
Registry last updated
May 30, 2019

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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