Trial · NCT02318693
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
NCT02318693, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2017-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355). Trials, record NCT02318693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318693
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
- NCT number
- NCT02318693
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 53 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Glibenclamide
- First posted
- 2014-12-17
- Last updated
- 2018-08-21
- Results first posted
- 2017-01-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 | Baseline (Day -2) and Day 13 | MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome. |
| Secondary | Change From Baseline in the Standard Deviation of Blood Glucose Levels | Baseline (Day -2) and Day 13 | SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome. |
| Secondary | Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Baseline (Day -2) and Day 13 | The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose. |
| Secondary | Change From Baseline in 24-hour Mean Glucose Level | Baseline (Day -2) and Day 13 | The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome. |
| Secondary | Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL) | Baseline (Day -2) and Day 13 | Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose \<70, \<60, \<50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 | Baseline (Day -2) and Day 13 | The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Standard Deviation of Blood Glucose Levels | Baseline (Day -2) and Day 13 | The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Baseline (Day -2) and Day 13 | The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Glucose Level | Baseline (Day -2) and Day 13 | The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL) | Baseline (Day -2) and Day 13 | The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 | Sitagliptin 50 mg | -18.5 | 95% Confidence Interval -30.0 to -7.1 | mg/dL | |
| Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 | Glibenclamide 2.50 mg TDD | -9.7 | 95% Confidence Interval -21.1 to 1.6 | mg/dL | |
| Change From Baseline in the Standard Deviation of Blood Glucose Levels | Sitagliptin 50 mg | -10.2 | 95% Confidence Interval -14.4 to -6.0 | mg/dL | |
| Change From Baseline in the Standard Deviation of Blood Glucose Levels | Glibenclamide 2.50 mg TDD | -4.2 | 95% Confidence Interval -8.4 to -0.1 | mg/dL | |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Sitagliptin 50 mg | Breakfast | -24.8 | 95% Confidence Interval -34.1 to -15.6 | mg/dL |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Glibenclamide 2.50 mg TDD | Breakfast | -12.0 | 95% Confidence Interval -21.1 to -2.9 | mg/dL |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Sitagliptin 50 mg | Lunch | -13.2 | 95% Confidence Interval -24.0 to -2.3 | mg/dL |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Glibenclamide 2.50 mg TDD | Lunch | 1.2 | 95% Confidence Interval -9.6 to 11.9 | mg/dL |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Sitagliptin 50 mg | Dinner | -9.0 | 95% Confidence Interval -20.9 to 2.9 | mg/dL |
| Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal | Glibenclamide 2.50 mg TDD | Dinner | -14.1 | 95% Confidence Interval -25.9 to -2.3 | mg/dL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin 50 mg | 26 | |
| Overall Study | STARTED | Glibenclamide 2.50 mg TDD | 27 | |
| Overall Study | Treated | Sitagliptin 50 mg | 26 | |
| Overall Study | Treated | Glibenclamide 2.50 mg TDD | 26 | |
| Overall Study | COMPLETED | Sitagliptin 50 mg | 26 | |
| Overall Study | COMPLETED | Glibenclamide 2.50 mg TDD | 26 | |
| Overall Study | NOT COMPLETED | Sitagliptin 50 mg | 0 | |
| Overall Study | NOT COMPLETED | Glibenclamide 2.50 mg TDD | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Periodontitis | Infections and infestations | Sitagliptin 50 mg | 2 | 26 | 2 |
| other | Periodontitis | Infections and infestations | Glibenclamide 2.50 mg TDD | 0 | 26 | 0 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin 50 mg | 2 | 26 | 5 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Glibenclamide 2.50 mg TDD | 3 | 26 | 4 |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | Sitagliptin 50 mg | 0 | 26 | 0 |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | Glibenclamide 2.50 mg TDD | 2 | 26 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | Sitagliptin 50 mg | 10 | 26 | 10 |
| other | Erythema | Skin and subcutaneous tissue disorders | Glibenclamide 2.50 mg TDD | 6 | 26 | 6 |
| other | Pruritis | Skin and subcutaneous tissue disorders | Sitagliptin 50 mg | 2 | 26 | 2 |
| other | Pruritis | Skin and subcutaneous tissue disorders | Glibenclamide 2.50 mg TDD | 2 | 26 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin 50 mg | ||
| Total, all-cause mortality | Glibenclamide 2.50 mg TDD | ||
| Total, other adverse events | Sitagliptin 50 mg | 11 | 26 |
| Total, other adverse events | Glibenclamide 2.50 mg TDD | 10 | 26 |
| Total, serious adverse events | Sitagliptin 50 mg | 0 | 26 |
| Total, serious adverse events | Glibenclamide 2.50 mg TDD | 0 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29770541 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitagliptin 50 mg vs Glibenclamide 2.50 mg TDD: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02318693
GET https://conductscience.org/api/trials/v1/NCT02318693/registered