A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)

This study has been terminated.
(Study was terminated due to inability to recruit patients.)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00846391
First received: February 17, 2009
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK8245 5 mg (twice a day) b.i.d.
Drug: MK8245 50 mg b.i.d.
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

    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 to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.



Enrollment: 14
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK8245 5 mg b.i.d.
MK8245
Drug: MK8245 5 mg (twice a day) b.i.d.

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.

Other Name: MK8245
Experimental: MK8245 50 mg b.i.d.
MK8245
Drug: MK8245 50 mg b.i.d.

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.

Other Name: MK8245
Placebo Comparator: Placebo
Placebo
Drug: Placebo

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Type 2 Diabetes Mellitus
  • 18 to 65 years of age

Exclusion Criteria:

  • History of Type 1 Diabetes or ketoacidosis
  • Have been treated with lipid lowering medications 4 weeks before starting the study
  • Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
  • Have had surgery in the last 30 days
  • History of active liver disease
  • History of coronary heart disease or congestive heart failure
  • Have had a stroke or transient ischemic neurological disorder in the past 6 months
  • Are Human Immunodeficiency Virus (HIV) Positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846391

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00846391     History of Changes
Other Study ID Numbers: MK8245-005, 2009_541
Study First Received: February 17, 2009
Results First Received: August 26, 2010
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014