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

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: March 10, 2014
Last verified: March 2014

June 30, 2010
March 10, 2014
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 ]
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.
  • Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 24 + 14 Day Post-Study Follow-up ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 24 Weeks ] [ Designated as safety issue: Yes ]
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 at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.
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 Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
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 (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.

The study includes an 8-week antihyperglycemic agent (AHA) wash-off period* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.

*: Wash-off only applicable to patients who were on acarbose and another AHA.

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: Acarbose
    Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks
    Other Name: Precose
  • Drug: Glimepiride
    Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.
    Other Names:
    • Amaryl®
    • Glimy
  • Experimental: Sitagliptin
    Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
    Interventions:
    • Drug: Sitagliptin phosphate
    • Drug: Acarbose
    • Drug: Glimepiride
  • Placebo Comparator: Placebo
    Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
    Interventions:
    • Drug: Comparator: Placebo
    • Drug: Acarbose
    • Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
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 thiazolidinedione (TZD), 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, CTRI/2011/10/002072
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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