Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

NCT01640873 | Completed Phase 1 Results

• 2 other identifiers: 8655-002MK-8655-002
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Number of Participants With One or More Adverse Events

  An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  Up to 14 days after the last dose of study drug (Up to 31 days)

• Number of Participants Discontinuing Study Drug Due to an Adverse Event

  An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  Up to 17 days

• Fasting Plasma Glucose (FPG)

  Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.

  Day 16 (Predose)

Secondary Outcomes (3)

• True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)

  24 hours post dose on Days 1, 7, and 14

• 24-Hour Weighted Mean Glucose (WMG)

  Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.

• Change From Baseline at 2 Hours Oral Glucose Tolerance Test

  Baseline and 2 hours after dosing on Days 1, 3, and 16

Study Arms (2)

MK-8655 80 mg/MK-8655 320 mg

EXPERIMENTAL

Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Drug: MK-8655

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Drug: Placebo

Interventions

MK-8655 DRUG

Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.

MK-8655 80 mg/MK-8655 320 mg

Placebo DRUG

Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of non-child bearing potential
• Body Mass Index ≤40 kg/m\^2
• Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
• In good health except for T2DM
• Willing to follow a standard diet
• Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

You may not qualify if:

• Mentally or legally incapacitated
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic or myeloproliferative diseases
• Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
• Has a history of Type 1 Diabetes and/or history of ketoacidosis
• Use of any lipid-lowering therapies in the past 3 months
• Non-permitted medication for a co-morbid condition
• Excessive alcohol or caffeine use
• Participation in another investigational study within 4 weeks prior to this study
• A history of significant multiple and/or severe allergies or anaphylactic reactions
• Regular user of any illicit drugs or history of alcohol abuse within 6 months

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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: July 12, 2012
• First Posted: July 16, 2012
• Study Start: September 19, 2012
• Primary Completion: December 20, 2012
• Study Completion: December 20, 2012
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-04