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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00846391
Recruitment Status : Terminated (Study was terminated due to inability to recruit patients.)
First Posted : February 18, 2009
Results First Posted : September 21, 2010
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: MK8245 5 mg (twice a day) b.i.d.
Drug: MK8245 50 mg b.i.d.
Drug: Placebo
Enrollment 14
Recruitment Details

First Patient In:10-Feb-2009

Early Termination*:11-Aug-2009

Last Patient Last Visit:19-Aug-2009

10 Centers Worldwide

*Study was terminated due to inability to recruit patients. Because it was not terminated for safety concerns, sites were to see patients for early termination visit at earliest convenience. The last patient was seen 19-Aug-2009.

Pre-assignment Details Patients 18-65 yrs not on antihyperglycemic agent (AHA) (A1C 7-10%),or single AHA (A1C 7-9.5%),or low dose dual AHA therapy (A1C 6.5-9.5%) with type 2 diabetes mellitus entered a 4-wk diet/exercise period (AHA wash-off if on AHA),after which,those with fasting glucose of 130-250 mg/dL were eligible for randomization (after a 2 wk pbo run-in period)
Arm/Group Title MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Hide Arm/Group Description Patients randomized to the 5 mg (twice a day) 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. 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. 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.
Period Title: Overall Study
Started 4 4 6
Completed 3 2 3
Not Completed 1 2 3
Reason Not Completed
Physician Decision             0             0             1
Study Terminated by Sponsor             1             2             2
Arm/Group Title MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo Total
Hide Arm/Group Description Patients randomized to the 5 mg (twice a day) 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 4 4 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 6 participants 14 participants
49.8  (13.4) 55.5  (7.7) 53.5  (7.5) 53.0  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 14 participants
Female
2
  50.0%
4
 100.0%
5
  83.3%
11
  78.6%
Male
2
  50.0%
0
   0.0%
1
  16.7%
3
  21.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 14 participants
Hispanic or Latino
2
  50.0%
2
  50.0%
3
  50.0%
7
  50.0%
Not Hispanic or Latino
2
  50.0%
2
  50.0%
3
  50.0%
7
  50.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 14 participants
Black OR African American 0 0 1 1
Multi-Racial 1 0 0 1
White 3 4 5 12
1.Primary Outcome
Title Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all patients with a baseline value and Week 4 value for this outcome.
Arm/Group Title MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Hide Arm/Group Description:
Patients randomized to the 5 mg (twice a day) 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.
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.
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.
Overall Number of Participants Analyzed 3 2 3
Mean (Standard Deviation)
Unit of Measure: mg/dL
-18.9  (22.1) 18.7  (6.7) -12.6  (1.4)
Time Frame Adverse experiences were collected from Visit 2 (Week -6) through Visit 6 (Week 4). Serious adverse experiences were collected for up to 14 days after the last dose of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Hide Arm/Group Description Patients randomized to the 5 mg (twice a day) 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. 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. 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.
All-Cause Mortality
MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK8245 5 mg b.i.d. MK8245 50 mg b.i.d. Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   1/4 (25.00%)   3/6 (50.00%) 
Eye disorders       
Punctate keratitis * 1  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Infections and infestations       
Cellulitis * 1  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Oral herpes * 1  2/4 (50.00%)  0/4 (0.00%)  0/6 (0.00%) 
Upper respiratory tract infection * 1  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Urinary tract infection * 1  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications       
Foot fracture * 1  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
Headadache * 1  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion * 1  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
This study was terminated due to the continuing inability to recruit patients. No efficacy analysis was performed because of insufficient sample size for meaningful analysis due to early study termination and insufficient sample size.
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: NCT00846391     History of Changes
Other Study ID Numbers: 8245-005
2009_541
First Submitted: February 17, 2009
First Posted: February 18, 2009
Results First Submitted: August 26, 2010
Results First Posted: September 21, 2010
Last Update Posted: February 5, 2016