Trial Outcomes & Findings for A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018) (NCT NCT00824616)
NCT ID: NCT00824616
Last Updated: 2015-07-28
Results Overview
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline (Day 1) and End of Treatment (Week 20)
Results posted on
2015-07-28
Participant Flow
Participant milestones
| Measure |
Placebo
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Creatinine/Creatinine Clearance
|
0
|
2
|
|
Overall Study
Hyperglycemia
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
n=34 Participants
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and End of Treatment (Week 20)Population: Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
n=34 Participants
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Level
|
-0.15 % HbA1c
Interval -0.65 to 0.34
|
-0.26 % HbA1c
Interval -0.76 to 0.23
|
PRIMARY outcome
Timeframe: From first dose of study drug (Week 0) to last dose of study drug (Week 20)Population: All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
n=34 Participants
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
|
6 participants
|
8 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
MK-0941
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=34 participants at risk
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
n=34 participants at risk
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
2.9%
1/34 • Number of events 1 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • Number of events 1 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
|
MK-0941
n=34 participants at risk
Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
General disorders
Fatigue
|
5.9%
2/34 • Number of events 3 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.8%
4/34 • Number of events 9 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
23.5%
8/34 • Number of events 50 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
3/34 • Number of events 4 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
5.9%
2/34 • Number of events 2 • From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic rescue therapy.
|
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 After multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site only. Sponsor can review publications 60 days prior to submission.
- Publication restrictions are in place
Restriction type: OTHER