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Completed

NCT Number: NCT00482729

MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for 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–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

  • Patient has type 2 diabetes mellitus
  • Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
  • Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
  • Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
  • Patient is a male, or a female who is unlikely to conceive

Exclusion criteria

  • Patient has type 1 diabetes mellitus or history of ketoacidosis

Treatment and study plan

sitagliptin phosphate (+) metformin hydrochloride

Drug

sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.

Other names: MK0431A, Janumet™

metformin

Drug

metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 18

    Time frame: Baseline and Week 18

    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. Number of Patients With A1C < 7.0% at Week 18

    Time frame: Week 18

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

    Time frame: Baseline and Week 18

    FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.

Other outcomes

  1. Change From Baseline in A1C at Week 44

    Time frame: Baseline and Week 44

    A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.

  2. Number of Patients With A1C < 7.0% at Week 44

    Time frame: Week 44

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 5, 2007
Registry last updated
Jun 9, 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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