Trial Outcomes & Findings for A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017) (NCT NCT00792935)
NCT ID: NCT00792935
Last Updated: 2015-12-17
Results Overview
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2015-12-17
Participant Flow
Participant milestones
| Measure |
MK-0941
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Glimepiride
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
68
|
68
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
MK-0941
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Glimepiride
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Baseline characteristics by cohort
| Measure |
MK-0941
n=72 Participants
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Glimepiride
n=71 Participants
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
55 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Mean 24-Hour Weighted Mean Glucose at Baseline
|
178.8 mg/dL
STANDARD_DEVIATION 33.9 • n=5 Participants
|
184.4 mg/dL
STANDARD_DEVIATION 38.4 • n=7 Participants
|
181.6 mg/dL
STANDARD_DEVIATION 36.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Outcome measures
| Measure |
MK-0941
n=72 Participants
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Glimepiride
n=71 Participants
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
|---|---|---|
|
Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
|
-43.4 mg/dL
Interval -50.0 to -36.8
|
-44.2 mg/dL
Interval -50.9 to -37.5
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.
Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL \[3.9 mmol/L\] with or without symptoms or symptomatic hypoglycemia.
Outcome measures
| Measure |
MK-0941
n=72 Participants
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
Glimepiride
n=71 Participants
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], after a 4-week dose titration/dose stabilization period.
|
|---|---|---|
|
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
|
32 participants
|
37 participants
|
Adverse Events
MK-0941
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Glimepiride
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0941
n=72 participants at risk
All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
|
Glimepiride
n=71 participants at risk
All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/72 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
1.4%
1/71 • Number of events 1 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
1/72 • Number of events 1 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
0.00%
0/71 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
Other adverse events
| Measure |
MK-0941
n=72 participants at risk
All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
|
Glimepiride
n=71 participants at risk
All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
5/72 • Number of events 5 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
1.4%
1/71 • Number of events 1 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/72 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
5.6%
4/71 • Number of events 4 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
38.9%
28/72 • Number of events 89 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
32.4%
23/71 • Number of events 78 • 14 weeks
All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
|
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 The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER