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

June 30, 2010
April 18, 2013
January 2011
March 2013   (final data collection date for primary outcome measure)
Change from baseline in hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
Change from baseline in A1C at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01177384 on ClinicalTrials.gov Archive Site
Change from baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
Change from baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: sitagliptin phosphate
    Sitagliptin, 100 mg tablet once daily, orally for 24 weeks
    Other Name: Januvia
  • 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
  • Experimental: Sitagliptin
    Acarbose + Sitagliptin phosphate 100 mg
    Interventions:
    • Drug: sitagliptin phosphate
    • Drug: Comparator: Acarbose
  • Placebo Comparator: Placebo
    Acarbose + Placebo
    Interventions:
    • Drug: Comparator: Placebo
    • Drug: Comparator: Acarbose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
393
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01177384
0431-130, 2010_543
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP