Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)

NCT ID: NCT02906709

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-17
• Study Completion Date: 2018-08-21

Brief Summary

This study will examine the efficacy of omarigliptin 25 mg once weekly compared to placebo in Japanese patients with T2DM who have inadequate glycemic control on insulin monotherapy in addition to diet and exercise therapy. The primary hypothesis of the study is that omarigliptin 25 mg once weekly provides greater reduction in hemoglobin A1C (HbA1c) compared with placebo as assessed by change from baseline to Week 16 [Phase A (double-blind period)].

Detailed Description

After a screening period of up to 2 weeks followed by a pretreatment period of 2 or 10 weeks, each participant will be receiving assigned double-blind treatment (omarigliptin 25 mg or placebo once weekly) for approximately 16 weeks (Phase A) followed by 36 weeks of open-label treatment (omarigliptin 25 mg once weekly, Phase B). After the end of treatment each participant will be followed for 21 days.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Omarigliptin 25 mg

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

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Omarigliptin, 25 mg orally once weekly

Insulin

Intervention Type: BIOLOGICAL

Insulin will be administered subcutaneously during the trial as monotherapy; dosage and administration following each package insert.

Placebo→Omarigliptin 25 mg

Placebo to Omarigliptin once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Omarigliptin, 25 mg orally once weekly

Placebo

Intervention Type: DRUG

Placebo to omarigliptin orally once weekly

Insulin

Intervention Type: BIOLOGICAL

Insulin will be administered subcutaneously during the trial as monotherapy; dosage and administration following each package insert.

Interventions

Omarigliptin

Omarigliptin, 25 mg orally once weekly

Intervention Type: DRUG

Placebo

Placebo to omarigliptin orally once weekly

Intervention Type: DRUG

Insulin

Insulin will be administered subcutaneously during the trial as monotherapy; dosage and administration following each package insert.

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-3102; MARIZEV®

Eligibility Criteria

Inclusion Criteria

• Have T2DM
• Meet all of following criteria at Week -2 of pre-randomization

1. On diet and exercise therapy for 6 weeks or longer, AND

2. Have been on a stable dosage and administration of insulin (8 to 40 units/day) for 10 weeks or longer, AND.

3. Have not been on any additional anti-hyperglycemic agent (AHAs, except for insulin monotherapy) for 8 weeks or longer, AND

4. HbA1c ≥7.5% and ≤10.0%

5. Fasting Plasma Glucose (FPG) ≥126 mg/dL and ≤230 mg/dL

• Have a body mass index (BMI) >18 kg/m^2 and <40 kg/m^2
• A male or female not of reproductive potential or a female of reproductive potential and agrees to remain abstinent from heterosexual activity, or agrees to use acceptable contraception to prevent pregnancy.

Exclusion Criteria

• Has type 1 diabetes mellitus or has a history of diabetic ketoacidosis.
• Has a history of being administered any of the following AHAs including fixed dose combination (FDC) containing the following ingredients:

1. Thiazolidinediones within 12 weeks

2. Glucagon-like peptide 1 (GLP-1) receptor agonists within 12 weeks

3. Omarigliptin at any time

• Has history of severe hypoglycemia with coma or loss of consciousness, or for whom hypoglycemia was observed greater or equal to two times per week within 8 weeks
• Is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks
• Has undergone a surgical procedure within 8 weeks or has planned major surgery during the study.
• Receives a lipid-lowering medication or thyroid replacement therapy at unstable dosage and administration
• Has poorly controlled hypertension
• Has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
• Has human immunodeficiency virus (HIV).
• Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder within the past 3 months
• Has severe peripheral vascular disease.
• Has a history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer:
• Has a clinically important hematological disorder.
• (For women of childbearing potential) has a positive urine pregnancy test.
• Is pregnant or breast feeding
• Is expected to conceive during the study
• Is expected to undergo hormonal therapy in preparation to donate eggs during the study
• Routinely consumes >14 alcoholic drinks per week or engages in binge drinking
• Has donated or plans to donate blood products of >300 mL within 8 weeks or during the study
• Has received or plans to receive blood products within 12 weeks or during the study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kadowaki T, Seino Y, Kaku K, Okamoto T, Kameya M, Sato A, Hirano T, Oshima N, Gantz I, O'Neill EA, Engel SS; Omarigliptin Study 039 Group. A randomized, placebo-controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control. Diabetes Obes Metab. 2021 Jun;23(6):1242-1251. doi: 10.1111/dom.14331. Epub 2021 Feb 17.

Reference Type: DERIVED

PMID: 33512755 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-3102-039

Identifier Type: OTHER

Identifier Source: secondary_id

163455

Identifier Type: REGISTRY

Identifier Source: secondary_id

3102-039

Identifier Type: -

Identifier Source: org_study_id