Back to resultsA Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK8245 5 mg (twice a day) b.i.d.
MK8245 50 mg b.i.d.
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MK8245 5 mg b.i.d.
MK8245 50 mg b.i.d.
Placebo
Arm Description
MK8245
MK8245
Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00846391
First Posted
February 17, 2009
Last Updated
February 4, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00846391
Brief Title
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to inability to recruit patients.
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK8245 5 mg b.i.d.
Arm Type
Experimental
Arm Description
MK8245
Arm Title
MK8245 50 mg b.i.d.
Arm Type
Experimental
Arm Description
MK8245
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MK8245 5 mg (twice a day) b.i.d.
Other Intervention Name(s)
MK8245
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MK8245 50 mg b.i.d.
Other Intervention Name(s)
MK8245
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Description
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.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
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