Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

NCT01088711 | Completed Phase 1 Results

• 1 other identifier: 3102-004
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.

Conditions

Type 2 Diabetes (T2D)

Keywords

Type 2 diabetes (T2D)

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing an Adverse Event (AE)

  Up to Day 36

• Number of Participants Withdrawing From Study Therapy Due to an AE

  Up to Day 22

Secondary Outcomes (5)

• Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15

  168 hours post-dose on Day 15

• Percent Inhibition of DPP-4 After Day 22

  168 hours post dose on Day 22

• WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration

  Through 4 hours post dose on Day 21

• WAA Total GLP-1 Concentration

  Through 4 hours post dose on Day 21

• Plasma Glucose Concentration

  Through 4 hours post dose on Day 21

Study Arms (4)

Healthy Omarigliptin

EXPERIMENTAL

Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).

Drug: Omarigliptin

Healthy Placebo

PLACEBO COMPARATOR

Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).

Drug: Placebo

T2D Omarigliptin

EXPERIMENTAL

Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).

Drug: Omarigliptin

T2D Placebo

PLACEBO COMPARATOR

Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).

Drug: Placebo

Interventions

Omarigliptin DRUG

Once-weekly 50 mg capsule

Also known as: MK-3102

Healthy Omarigliptin; T2D Omarigliptin

Placebo DRUG

Once-weekly placebo capsule

Healthy Placebo; T2D Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obese (body mass index \[BMI\] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
• has been diagnosed with T2D (Panel B)
• is not actively participating in a weight loss program

You may not qualify if:

• has a history of clinically-significant disease (other than T2D)
• has a history of cancer
• has estimated creatinine clearance ≤60 mL/min
• is unable to refrain from or anticipates the use of any prescription or non-prescription medication
• consumes excessive amounts of alcohol or caffeine
• has participated in a previous omarigliptin study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, in Obese Participants With and Without Type 2 Diabetes Mellitus. Clin Ther. 2016 Mar;38(3):516-30. doi: 10.1016/j.clinthera.2015.12.020. Epub 2016 Feb 9.

  PMID: 26869191 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: March 11, 2010
• Primary Completion: May 11, 2010
• Study Completion: May 11, 2010
• Last Updated: September 10, 2018
• Results First Posted: December 24, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share