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Completed

NCT Number: NCT00813995

A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

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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–78 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

  • 18 - 78 years of age
  • Currently on metformin monotherapy

Exclusion criteria

  • History of Type 1 diabetes mellitus or ketoacidosis
  • Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
  • Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
  • Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
  • History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
  • HIV positive
  • Pregnant, breast-feeding or planning to become pregnant during the study
  • User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

Treatment and study plan

Comparator: Sitagliptin phosphate

Drug

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Other names: GLUCOPHAGE®

Comparator: placebo

Drug

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Other names: GLUCOPHAGE®

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 24

    Time frame: Baseline and Week 24

    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Secondary outcomes

  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day

    Time frame: Baseline and Week 24

    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

  2. Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day

    Time frame: Baseline and Week 24

    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

  3. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2008
Registry last updated
May 12, 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.

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