Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo to omarigliptin; Drug: Placebo to sitagliptin; Drug: Omarigliptin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703221

3102-020

132239 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 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 omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

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). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Enrollment: 414 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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, omarigliptin and/or sitagliptin anytime

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 3 patient groups, including a placebo group

Omarigliptin 25 mg (Phase A+B)

Experimental group

Description:

Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)

Treatment:

Drug: Omarigliptin

Drug: Placebo to sitagliptin

Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

Active Comparator group

Description:

Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Treatment:

Drug: Sitagliptin

Drug: Placebo to omarigliptin

Drug: Omarigliptin

Placebo (Phase A) switching to Omarigliptin (Phase B)

Placebo Comparator group

Description:

Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Treatment:

Drug: Placebo to omarigliptin

Drug: Omarigliptin

Drug: Placebo to sitagliptin