Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01177384
First received: June 30, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

This study will evaluate whether the addition of Sitagliptin reduces Hemoglobin A1C more than the addition of placebo for patients with type 2 Diabetes Mellitus on a steady dose of acarbose.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: sitagliptin phosphate
Drug: Comparator: Placebo
Drug: Comparator: Acarbose
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, Multicenter, Randomized, Placebo-Controlled, Double-Blind 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 Diet/Exercise Therapy and Acarbose Monotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Enrollment: 393
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Acarbose + Sitagliptin phosphate 100 mg
Drug: sitagliptin phosphate
Sitagliptin, 100 mg tablet once daily, orally for 24 weeks
Other Name: Januvia
Drug: Comparator: Acarbose
Acarbose 50 mg or 100 mg tablet, 3 times daily, orally for 24 weeks
Other Name: Precose
Placebo Comparator: Placebo
Acarbose + Placebo
Drug: Comparator: Placebo
Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks
Drug: Comparator: Acarbose
Acarbose 50 mg or 100 mg tablet, 3 times daily, orally for 24 weeks
Other Name: Precose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has T2DM and is on acarbose alone at a stable dose of at least 50 mg t.i.d.(three times a day) for at least 10 weeks or on acarbose at a stable dose of at least 50 mg t.i.d. (three times a day) for at least 10 weeks in combination with another antihyperglycemic agent (AHA)
  • is at least 18 years of age (for participants in India: between 18 and 65 years of age)
  • male or female who is unlikely to conceive (not of reproductive potential, or agrees to remain abstinent or use [or have partner use] acceptable birth control if of reproductive potential)

Exclusion Criteria:

  • has a history of type 1 diabetes mellitus
  • use of dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, or insulin
  • has the following cardiovascular disorders: acute coronary syndrome; new or worsening symptoms of coronary heart disease; coronary artery intervention; stroke or transient ischemic neurological disorder
  • has liver or kidney disease
  • has cancer or any clinically significant disease or disorder as judged by the Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177384

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01177384     History of Changes
Other Study ID Numbers: 0431-130, 2010_543
Study First Received: June 30, 2010
Last Updated: April 18, 2013
Health Authority: China: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes Mellitus
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Sitagliptin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014