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Completed

NCT Number: NCT00087516

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

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

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Key information

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 with type 2 diabetes mellitus
  • Patient is not pregnant or breastfeeding
  • Male or female patient unlikely to conceive
  • Patient not on an antihyperglycemic drug

Exclusion criteria

  • Patient has history of type 1 diabetes mellitus
  • Patient has history of ketoacidosis
  • Patient requires insulin within 8 weeks prior to start of study
  • Patient on weight loss program and is not in maintenance phase
  • Patient taking weight loss medication within 8 weeks prior to start of study
  • Patient on or likely to require = 14 days or repeated courses of corticosteroids
  • Patient taking immunosuppressive/immunomodulating medication
  • Patient taking digoxin or other cardiac medication
  • Patient has undergone surgical general anesthesia within 30 days prior to start of study
  • Patient taking investigational drug within 8 weeks prior to start of study
  • Patient is diagnosed with liver disease
  • Patient has chronic myopathy, progressive neurological/neuromuscular disorder
  • Patient has with severe cardiac conditions within the last 6 months
  • Patient is Human immunodeficiency virus (HIV) positive
  • Patient has hematological disorder
  • Patient has history of malignancy
  • Patient has history of alcohol or drug abuse within the past 3 years

Treatment and study plan

Sitagliptin (MK0431)

Drug

Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Other names: MK0431, Januvia

Sitagliptin

Drug

Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Other names: MK0431, Januvia

Placebo

Drug

Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Metformin - Rescue

Drug

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Other names: Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Primary outcomes

  1. Change From Baseline in A1C at Week 24

    Time frame: Weeks 0-24

    A1C is measured as a 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 FPG at Week 24

    Time frame: Weeks 0-24

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

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

    Time frame: Weeks 0-24

    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.

  3. Change From Baseline in A1C at Week 104

    Time frame: Weeks 0-104

    A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.

  4. Change From Baseline in FPG at Week 104

    Time frame: Weeks 0-104

    Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.

  5. Change From Baseline in 2-hr PMG at Week 104

    Time frame: Weeks 0-104

    Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Jul 13, 2004
Registry last updated
Jul 3, 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.

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