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Completed

NCT Number: NCT00541775

Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has Type 2 diabetes
  • Currently taking metformin >1500 mg/day for at least 10 weeks
  • Male or female

Exclusion criteria

  • Patient has peripheral edema
  • History of type 1 diabetes
  • Patient required insulin within prior 8 weeks
  • Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
  • Participating in a weight loss program

Treatment and study plan

Sitagliptin

Drug

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

Other names: Januvia

Comparator: Rosiglitazone

Drug

Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.

Other names: Avandia

Comparator: placebo

Drug

placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.

Comparator: Metformin

Drug

Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.

Primary outcomes

  1. Hemoglobin A1C (A1C) at Week 18

    Time frame: Baseline and 18 Weeks

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

    The study hypothesis comparison was between sitagliptin versus placebo.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) at Week 18

    Time frame: Baseline and 18 Weeks

    The change from baseline is the Week 18 FPG minus the Week 0 FPG.

  2. 2-hour Post-meal Glucose (PMG) at Week 18

    Time frame: Baseline and 18 Weeks

    The change from baseline is the Week 18 PMG minus the Week 0 PMG.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Placebo and Active 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
2006
Primary completion
2007
Study completion
2007
First posted
Oct 10, 2007
Registry last updated
Aug 24, 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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