Trial Outcomes & Findings for The OBSTACLE Hypoglycemia Study (MK-0000-158) (NCT NCT00907881)
NCT ID: NCT00907881
Last Updated: 2015-04-21
Results Overview
Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
COMPLETED
1069 participants
Week 12
2015-04-21
Participant Flow
Participant milestones
| Measure |
All Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Overall Study
STARTED
|
1069
|
|
Overall Study
COMPLETED
|
984
|
|
Overall Study
NOT COMPLETED
|
85
|
Reasons for withdrawal
| Measure |
All Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
59
|
|
Overall Study
Noncompliance
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Missing discontinuation information
|
15
|
Baseline Characteristics
The OBSTACLE Hypoglycemia Study (MK-0000-158)
Baseline characteristics by cohort
| Measure |
All Participants
n=1069 Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Age, Continuous
|
52.21 years
STANDARD_DEVIATION 10.70 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
472 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
589 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
8 participants
n=5 Participants
|
|
Region of Enrollment
India
|
1069 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.
Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
Outcome measures
| Measure |
All Participants
n=950 Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
|
-0.1215 Correlation coefficient
95% Confidence Interval 1.90 • Interval -0.1836 to -0.0583
|
SECONDARY outcome
Timeframe: Week 12Population: Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.
Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.
Outcome measures
| Measure |
All Participants
n=950 Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Age 35-44 years, n=171
|
0.87 Score on a scale
Standard Deviation 1.36
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Duration of T2DM <5 years, n=640
|
0.88 Score on a scale
Standard Deviation 1.36
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Duration of T2DM 5-10 years, n=239
|
1.15 Score on a scale
Standard Deviation 1.52
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
2 background oral hypoglycemic agents, n=69
|
1.30 Score on a scale
Standard Deviation 1.61
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
3 background oral hypoglycemic agents, n=7
|
0.00 Score on a scale
Standard Deviation 0.00
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Male, n=526
|
0.87 Score on a scale
Standard Deviation 1.37
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Female, n=417
|
1.12 Score on a scale
Standard Deviation 1.46
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Age 18-34 years, n=45
|
0.91 Score on a scale
Standard Deviation 1.62
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Age 45-64 years, n=595
|
0.96 Score on a scale
Standard Deviation 1.39
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Age 65 years and older, n=138
|
1.18 Score on a scale
Standard Deviation 1.49
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Mild hypoglycemia, n=286
|
1.59 Score on a scale
Standard Deviation 1.38
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Moderate hypoglycemia, n=168
|
2.36 Score on a scale
Standard Deviation 1.49
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Severe hypoglycemia, n=15
|
2.53 Score on a scale
Standard Deviation 1.68
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Body mass index <25 kg/m^2, n=370
|
1.01 Score on a scale
Standard Deviation 1.44
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Body mass index 25-30 kg/m^2, n=394
|
0.95 Score on a scale
Standard Deviation 1.42
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Body mass index >30 kg/m^2, n=183
|
0.96 Score on a scale
Standard Deviation 1.37
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Duration of T2DM >10 years, n=49
|
1.29 Score on a scale
Standard Deviation 1.46
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
No background oral hypoglycemic agents, n=20
|
0.60 Score on a scale
Standard Deviation 0.99
|
|
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
1 background oral hypoglycemic agent, n=854
|
0.97 Score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Week 12Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
Outcome measures
| Measure |
All Participants
n=950 Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Male, n=526
|
-0.1654 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Body mass index <25 kg/m^2, n=370
|
-0.0100 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Body mass index 25-30 kg/m^2, n=394
|
-0.2188 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Body mass index >30 kg/m^2, n=183
|
-0.1688 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Duration of diabetes <5 years, n=640
|
-0.1201 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Duration of diabetes 5-10 years, n=239
|
-0.1503 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Female, n=417
|
-0.0756 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Age 18-34 years, n=45
|
-0.1636 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Age 35-44 years, n=171
|
-0.1034 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Age 45-64 years, n=595
|
-0.1222 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Age 65 years and older, n=138
|
-0.0984 Correlation coefficient
|
|
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Duration of diabetes >10 years, n=49
|
-0.1316 Correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All enrolled participants with available data at both Baseline and Week 12.
Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.
Outcome measures
| Measure |
All Participants
n=899 Participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s).
|
|---|---|
|
Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12
|
0.0026 Correlation coefficient
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=1069 participants at risk
|
|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
46.0%
492/1069 • Number of events 2968
No adverse events were recorded separately other than hypoglycemia.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The study 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 study sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER