Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
Status and phase
Completed
Phase 3
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
Full description
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.
Enrollment
585 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
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: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
585 participants in 10 patient groups, including a placebo group
Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)
Experimental group
Description:
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Omarigliptin 25 mg/Glinides (Phase A+B)
Experimental group
Description:
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)
Experimental group
Description:
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)
Experimental group
Description:
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Omarigliptin 25 mg/α-GIs (Phase A+B)
Experimental group
Description:
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
Placebo Comparator group
Description:
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
Placebo Comparator group
Description:
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
Placebo Comparator group
Description:
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
Placebo Comparator group
Description:
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
Placebo Comparator group
Description:
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.
Treatment:
Drug: Omarigliptin
Drug: Matching placebo to omarigliptin
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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