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

February 17, 2009
June 3, 2011
December 2008
August 2009   (final data collection date for primary outcome measure)
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.

Assess the effect of MK8245 compared to placebo on 24-hour Weighted Mean Glucose from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00846391 on ClinicalTrials.gov Archive Site
Not Provided
Asses the safety and tolerability of MK8245 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
  • 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.

  • Experimental: MK8245 5 mg b.i.d.
    MK8245
    Intervention: Drug: MK8245 5 mg (twice a day) b.i.d.
  • Experimental: MK8245 50 mg b.i.d.
    MK8245
    Intervention: Drug: MK8245 50 mg b.i.d.
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00846391
MK8245-005, 2009_541
Not Provided
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP