Text Size

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
ClinicalTrials.gov Identifier:
NCT01076075
First received: February 24, 2010
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1C (%) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to An Adverse Event [ Time Frame: Week 0 to Week 54 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in 2-hour Post-Meal Glucose at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 24 value minus the baseline value.


Enrollment: 427
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: July 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076075

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01076075     History of Changes
Other Study ID Numbers: 0431-229, 2010_513, MK-0431-229
Study First Received: February 24, 2010
Results First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: Malaysia: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Ministry of Health

Keywords provided by Merck:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Pioglitazone
Sitagliptin
Gliclazide
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013