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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00790556
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : January 20, 2011
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: MK8245
Drug: Comparator: Placebo
Enrollment 14
Recruitment Details  
Pre-assignment Details For subjects taking anti-hyperglycemic agents and who otherwise qualified for the study, a 4-week washout/run-in period was required prior to dosing.
Arm/Group Title MK8245 Then Placebo Placebo Then MK8245
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During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Period Title: Treatment Period 1
Started 8 6
Completed 6 6
Not Completed 2 0
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             1             0
Period Title: Washout After Period 1
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Treatment Period 2
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
49.43
(30 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
2
  14.3%
Male
12
  85.7%
1.Primary Outcome
Title Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
Hide Description

An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.

Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.

Drug-relatedness was determined by the investigator based on clinical judgement.

Time Frame 56 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).
Arm/Group Title MK8245 Placebo
Hide Arm/Group Description:

MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
With clinical adverse events (CAEs) 4 5
With drug-related CAEs 0 0
With Serious CAEs 0 0
With laboratory adverse events (LAEs) 0 0
With drug-related LAEs 0 0
With serious LAEs 0 0
2.Primary Outcome
Title Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
Hide Description Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.
Time Frame Day 14 of each 14-day Treatment Period
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Hide Analysis Population Description
Subjects who discontinued were not used in the analysis.
Arm/Group Title MK8245 Placebo
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MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
-1.09  (1.54) -0.87  (0.94)
3.Other Pre-specified Outcome
Title Hepatic Glucose Production (HGP) at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who discontinued were not used in the analysis.
Arm/Group Title MK8245 Placebo
Hide Arm/Group Description:

MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
1.87  (0.36) 1.95  (0.36)
Time Frame Treatment Period 1, Days 1 to 14, 14 day washout, Treatment Period 2, Days 1 to 14, 14 days to post study.
Adverse Event Reporting Description Spontaneous collection of all AEs; All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).
 
Arm/Group Title MK8245 Placebo
Hide Arm/Group Description

MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.

Includes results of this treatment from both treatment periods.

All-Cause Mortality
MK8245 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK8245 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MK8245 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/14 (28.57%)   5/14 (35.71%) 
Eye disorders     
Cataract *  1/14 (7.14%)  0/14 (0.00%) 
Lacrimation increased *  1/14 (7.14%)  0/14 (0.00%) 
Gastrointestinal disorders     
Flatulence *  1/14 (7.14%)  1/14 (7.14%) 
General disorders     
Chest pain *  1/14 (7.14%)  0/14 (0.00%) 
Chills *  1/14 (7.14%)  0/14 (0.00%) 
Feeling hot *  1/14 (7.14%)  0/14 (0.00%) 
Infusion site haemorrhage *  1/14 (7.14%)  0/14 (0.00%) 
Malaise *  1/14 (7.14%)  0/14 (0.00%) 
Infections and infestations     
Body tinea *  0/14 (0.00%)  1/14 (7.14%) 
Cellulitis *  1/14 (7.14%)  0/14 (0.00%) 
Influenza *  0/14 (0.00%)  1/14 (7.14%) 
Oral herpes *  0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  1/14 (7.14%)  1/14 (7.14%) 
Back pain *  0/14 (0.00%)  1/14 (7.14%) 
Neck pain *  1/14 (7.14%)  0/14 (0.00%) 
Nervous system disorders     
Headache *  3/14 (21.43%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  0/14 (0.00%)  1/14 (7.14%) 
Productive cough *  0/14 (0.00%)  1/14 (7.14%) 
Upper respiratory tract congestion *  0/14 (0.00%)  1/14 (7.14%) 
*
Indicates events were collected by non-systematic assessment
Stat. analysis of HGP was not performed as insulin suppression lead to a near complete suppression of HGP in both placebo and MK-8245 treated subjects, making it impossible to determine if MK-8245 could lead to a greater insulin effect than placebo
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00790556     History of Changes
Other Study ID Numbers: 8245-004
2008_582
First Submitted: November 7, 2008
First Posted: November 13, 2008
Results First Submitted: September 10, 2010
Results First Posted: January 20, 2011
Last Update Posted: February 17, 2016