Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
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|ClinicalTrials.gov Identifier: NCT00972322|
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : June 12, 2014
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: MK-8245 Drug: Comparator: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes|
|Actual Study Start Date :||August 24, 2009|
|Actual Primary Completion Date :||January 12, 2010|
|Actual Study Completion Date :||January 26, 2010|
Experimental: MK-8245 50 mg
MK-8245, 50 mg, twice daily for 28 days
MK-8245 50 mg twice daily for 28 days
Placebo Comparator: Placebo
Placebo to MK-8245, 50 mg, twice daily
Drug: Comparator: placebo
matching placebo to MK-8245 twice daily for 28 days
- Change From Baseline in the 24-hour Weighted Mean Glucose (WMG) [ Time Frame: Baseline and Day 28 ]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.
- Number of Participants Who Experienced Serious or Non-serious Adverse Events [ Time Frame: Up to Day 31 ]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.
- Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 28 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972322
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|