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Completed

NCT Number: NCT01076075

A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

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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

  • Type 2 diabetes mellitus
  • Hemoglobin A1C of ≥7.5% and ≤10.5%
  • Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
  • Male, or a female who is highly unlikely to conceive

Exclusion criteria

  • Type 1 diabetes mellitus or ketoacidosis
  • Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
  • On a weight loss program not in the maintenance phase or on a weight loss medication
  • History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
  • HIV positive
  • Pregnant

Treatment and study plan

sitagliptin phosphate

Drug

Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks

Other names: Januvia

Comparator: placebo to pioglitazone

Drug

Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks

Comparator: placebo to Sitagliptin

Drug

Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks

Comparator: pioglitazone

Drug

Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks

Other names: Actos;

Glimepiride or gliclazide

Drug

Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide

metformin

Drug

Phase A (Weeks 0-24): stable dose, as prescribed

by investigator, of metformin; Phase B (Weeks 24-

54): stable dose, as prescribed by investigator, of

metformin

Pioglitazone rescue therapy

Drug

Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

Other names: Actos

Primary outcomes

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

    Time frame: Baseline and Week 24

    Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.

  2. Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54

    Time frame: Week 0 to Week 54

  3. Number of Participants Discontinuing Study Drug Due to An Adverse Event

    Time frame: Week 0 to Week 54

Secondary outcomes

  1. Change From Baseline in 2-hour Post-Meal Glucose at Week 24

    Time frame: Baseline and Week 24

    Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.

  2. Change From Baseline in Fasting Plasma Glucose at Week 24

    Time frame: Baseline to Week 24

    Change from baseline reflects the Week 24 value minus the baseline value.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 25, 2010
Registry last updated
Jun 5, 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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