Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2) (NCT NCT00846391)
NCT ID: NCT00846391
Last Updated: 2016-02-05
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2016-02-05
Participant Flow
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.
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)
Participant milestones
| Measure |
MK8245 5 mg b.i.d.
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.
|
MK8245 50 mg b.i.d.
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.
|
Placebo
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 Study
STARTED
|
4
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
MK8245 5 mg b.i.d.
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.
|
MK8245 50 mg b.i.d.
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.
|
Placebo
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 Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
2
|
2
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
Baseline characteristics by cohort
| Measure |
MK8245 5 mg b.i.d.
n=4 Participants
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.
|
MK8245 50 mg b.i.d.
n=4 Participants
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.
|
Placebo
n=6 Participants
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
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
55.5 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
53.5 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
53.0 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black OR African American
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
12 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The analysis population included all patients with a baseline value and Week 4 value for this outcome.
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.
Outcome measures
| Measure |
MK8245 5 mg b.i.d.
n=3 Participants
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.
|
MK8245 50 mg b.i.d.
n=2 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
|
-18.9 mg/dL
Standard Deviation 22.1
|
18.7 mg/dL
Standard Deviation 6.7
|
-12.6 mg/dL
Standard Deviation 1.4
|
Adverse Events
MK8245 5 mg b.i.d.
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK8245 50 mg b.i.d.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK8245 5 mg b.i.d.
n=4 participants at risk
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.
|
MK8245 50 mg b.i.d.
n=4 participants at risk
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.
|
Placebo
n=6 participants at risk
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.
|
|---|---|---|---|
|
Eye disorders
Punctate keratitis
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
16.7%
1/6 • 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.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
|
Infections and infestations
Oral herpes
|
50.0%
2/4 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
16.7%
1/6 • 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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
25.0%
1/4 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
|
Nervous system disorders
Headadache
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
16.7%
1/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 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.
|
25.0%
1/4 • 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.
|
0.00%
0/6 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER