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MK-3102 Phase III Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015 AM1)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: MK-3102 (Drug); Matching placebo to MK-3102 (Drug); Basal medication (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This study will examine the safety and efficacy of the addition of MK-3102 in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

Clinical Details

Official title: A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percentage of participants who experienced at least one adverse event

Percentage of participants who experienced at least one adverse event

Percentage of participants who discontinued from the study due to an adverse event

Percentage of participants who discontinued from the study due to an adverse event

Secondary outcome: Change from baseline in hemoglobin A1c (HbA1c)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has type 2 diabetes mellitus

- Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic

agent monotherapy Exclusion Criteria:

- History of type 1 diabetes mellitus or a history of ketoacidosis

- History of any of the following medications: TZD (for participants whose basal

medication is not TZD) and/or insulin within 12 weeks prior to study participation, MK-3102 anytime

Locations and Contacts

Additional Information

Starting date: October 2012
Last updated: May 29, 2014

Page last updated: August 23, 2015

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