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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01076075
First received: February 24, 2010
Last updated: May 4, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin phosphate Drug: Comparator: placebo to pioglitazone Drug: Comparator: placebo to Sitagliptin Drug: Comparator: pioglitazone Drug: Glimepiride or gliclazide Drug: Metformin Drug: Pioglitazone rescue therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.

  • Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54 [ Time Frame: Week 0 to Week 54 ]
  • Number of Participants Discontinuing Study Drug Due to An Adverse Event [ Time Frame: Week 0 to Week 54 ]

Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 427
Actual Study Start Date: June 3, 2010
Study Completion Date: January 19, 2012
Primary Completion Date: July 11, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: placebo/pioglitazone
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
Drug: Comparator: placebo to Sitagliptin
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
Drug: Comparator: pioglitazone
Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
Other Name: Actos;
Drug: Glimepiride or gliclazide
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
Drug: Metformin

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

Drug: Pioglitazone rescue therapy
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 Name: Actos
Experimental: Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
Drug: Sitagliptin phosphate
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 Name: Januvia
Drug: Comparator: placebo to pioglitazone
Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
Drug: Glimepiride or gliclazide
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
Drug: Metformin

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

Drug: Pioglitazone rescue therapy
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 Name: Actos

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076075

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01076075     History of Changes
Other Study ID Numbers: 0431-229
2010_513
MK-0431-229 ( Other Identifier: protocol number )
Study First Received: February 24, 2010
Results First Received: June 28, 2012
Last Updated: May 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Glimepiride
Metformin
Sitagliptin Phosphate
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 17, 2017