Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

NCT00972322 | Completed Phase 1 Results

• 3 other identifiers: 8245-012MK-8245-0122009_655
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)

  The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

  Baseline and Day 28

• Number of Participants Who Experienced Serious or Non-serious Adverse Events

  An adverse event (AE) 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. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  Up to Day 31

• Number of Participants Discontinuing Study Drug Due to an AE

  An adverse event (AE) 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 Day 28

Study Arms (2)

MK-8245 50 mg

EXPERIMENTAL

MK-8245, 50 mg, twice daily for 28 days

Drug: MK-8245

Placebo

PLACEBO COMPARATOR

Placebo to MK-8245, 50 mg, twice daily

Drug: Comparator: placebo

Interventions

MK-8245 DRUG

MK-8245 50 mg twice daily for 28 days

MK-8245 50 mg

Comparator: placebo DRUG

matching placebo to MK-8245 twice daily for 28 days

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:

• Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
• Subject is willing to follow a weight-maintaining diet and exercise program during the study
• Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

You may not qualify if:

• Subject has a history of stroke, chronic seizures, or major neurological disorder
• Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
• Subject has a history of type 1 diabetes
• Subject has used contact lenses within the last 6 months
• Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
• Subject has more than 3 alcoholic beverages per day
• Subject has more than 6 servings of caffeine a day
• Subject has participated in a previous MK8245 study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(5-(3-(4-(2-bromo-5-fluorophenoxy)piperidin-1-yl)isoxazol-5-yl)-2H-tetrazol-2-yl)acetic acid

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 Monitor

  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: September 3, 2009
• First Posted: September 4, 2009
• Study Start: August 24, 2009
• Primary Completion: January 12, 2010
• Study Completion: January 26, 2010
• Last Updated: September 10, 2018
• Results First Posted: June 12, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share