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MK-3102 Phase III Clinical Trial - Placebo- and Sitagliptin-controlled Monotherapy Study in Japanese Participants With Type 2 Diabetes Mellitis (MK-3102-020)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703221
First received: October 5, 2012
Last updated: May 12, 2014
Last verified: May 2014

October 5, 2012
May 12, 2014
October 2012
April 2014   (final data collection date for primary outcome measure)
  • Change from baseline for hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percentage of participants who experienced at least one adverse event [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experienced at least one adverse event [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01703221 on ClinicalTrials.gov Archive Site
  • Change from baseline for 2-hour post meal glucose (PMG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MK-3102 Phase III Clinical Trial - Placebo- and Sitagliptin-controlled Monotherapy Study in Japanese Participants With Type 2 Diabetes Mellitis (MK-3102-020)
A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

The purpose of this study is to assess the efficacy of MK-3102 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of MK-3102 25 mg weekly. The primary hypotheses are that after 24 weeks 1) MK-3102 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) the mean change from baseline in HbA1c in participants treated with MK-3102 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MK-3102
    MK-3102 25 mg capsule administered orally once weekly
  • Drug: Sitagliptin
    Sitagliptin 50 mg tablet administered orally once daily
    Other Name: Januvia®
  • Drug: Placebo to MK-3102
    Matching placebo to MK-3102 25 mg capsule administered orally once weekly
  • Drug: Placebo to sitagliptin
    Matching placebo to sitagliptin 50 mg tablet administered orally once daily
  • Experimental: MK-3102
    MK-3102 25 mg administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
    Interventions:
    • Drug: MK-3102
    • Drug: Placebo to sitagliptin
  • Active Comparator: Sitagliptin
    Sitagliptin 50 mg administered orally once daily and matching placebo to MK-3102 administered orally once weekly for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
    Interventions:
    • Drug: MK-3102
    • Drug: Sitagliptin
    • Drug: Placebo to MK-3102
  • Placebo Comparator: Placebo
    Matching placebo to MK-3102 administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
    Interventions:
    • Drug: MK-3102
    • Drug: Placebo to MK-3102
    • Drug: Placebo to sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
414
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has type 2 diabetes mellitus

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, MK-3102 and/or sitagliptin anytime
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01703221
3102-020, 132239
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

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