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Completed

NCT Number: NCT00106704

Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

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

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 with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion criteria

  • Patients with Type 1 Diabetes Mellitus

Treatment and study plan

Comparator: Sitagliptin

Drug

sitagliptin 10 mg tablet, once daily for 54 weeks

Comparator: placebo

Drug

Placebo oral tablet once daily for 24 weeks

Comparator: pioglitazone

Drug

Pioglitazone 30 mg tablet once daily for 30 weeks

Primary outcomes

  1. Change From Baseline in A1C at Week 24

    Time frame: Baseline and 24 Weeks

    Hemoglobin A1C (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 FPG at Week 24

    Time frame: Baseline and 24 Weeks

    The change from baseline is the Week 24 Fasting Plasma Glucose (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, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Mar 30, 2005
Registry last updated
Jul 1, 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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