A Phase 4 interventional study of Sitagliptin and Glibenclamide in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment
This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.
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Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
Drug: Sitagliptin
Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
Drug: Glibenclamide
Sitagliptin 50 mg orally once a day before breakfast for 14 days
Also known as: MK-0431
Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days
Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at 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.
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in the Standard Deviation of Blood Glucose Levels
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.
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal
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.
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in 24-hour Mean Glucose Level
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.
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)
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.
Time frame: Baseline (Day -2) and Day 13
Screening for study inclusion was performed over a 4-week period. Adults with type 2 diabetes were randomized into the study.
| Milestone | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| Started | 26 | 27 |
| Treated | 26 | 26 |
| Completed | 26 | 26 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| mg/dL | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 | -18.5 (-30.0 to -7.1) | -9.7 (-21.1 to 1.6) |
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.
| mg/dL | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| Change From Baseline in the Standard Deviation of Blood Glucose Levels | -10.2 (-14.4 to -6.0) | -4.2 (-8.4 to -0.1) |
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.
| mg/dL | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| Breakfast | -24.8 (-34.1 to -15.6) | -12.0 (-21.1 to -2.9) |
| Lunch | -13.2 (-24.0 to -2.3) | 1.2 (-9.6 to 11.9) |
| Dinner | -9.0 (-20.9 to 2.9) | -14.1 (-25.9 to -2.3) |
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.
| mg/dL | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| Change From Baseline in 24-hour Mean Glucose Level | -19.1 (-28.5 to -9.7) | -34.8 (-44.0 to -25.5) |
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.
| Percent change | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| <70 mg/dL | -0.3 (-1.6 to 1.0) | 0.8 (-0.5 to 2.1) |
| <60 mg/dL | -0.4 (-1.3 to 0.5) | 0.2 (-0.7 to 1.1) |
| <50 mg/dL | -0.3 (-0.8 to 0.2) | -0.3 (-0.7 to 0.2) |
Collected over Up to 4 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin 50 mg | — | 0/26 (0%) | 11/26 (42.3%) |
| Glibenclamide 2.50 mg TDD | — | 0/26 (0%) | 10/26 (38.5%) |
| Event | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 10/26 | 6/26 |
| HypoglycaemiaMetabolism and nutrition disorders | 2/26 | 3/26 |
| PeriodontitisInfections and infestations | 2/26 | 0/26 |
| Dermatitis ContactSkin and subcutaneous tissue disorders | 0/26 | 2/26 |
| PruritisSkin and subcutaneous tissue disorders | 2/26 | 2/26 |
Baseline data is provided for the Full Analysis Set (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 analysis, and with applicable baseline data.
| Age, Continuous(Years) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Mean | 60.2 ± 8.4 | 59.5 ± 10.7 | 59.8 ± 9.5 |
| Age, Customized(Participants) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| <65 years | 15 | 16 | 31 |
| >=65 years | 11 | 10 | 21 |
| Sex: Female, Male(Participants) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 26 | 25 | 51 |
| Body Weight(kg) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Mean | 70.2 ± 8.2 | 70.7 ± 11.2 | 70.5 ± 9.7 |
| Height(cm) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Mean | 169.5 ± 5.4 | 169.3 ± 5.3 | 169.4 ± 5.3 |
| Body Mass Index(kg/m^2) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Mean | 24.4 ± 2.1 | 24.6 ± 3.0 | 24.5 ± 2.6 |
| Duration of Diabetes Mellitus(Years) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Mean | 6.4 ± 5.4 | 9.9 ± 5.5 | 8.2 ± 5.7 |
| Smoking Status(Participants) | Sitagliptin 50 mg | Glibenclamide 2.50 mg TDD | Total |
|---|---|---|---|
| Current Smoker | 8 | 9 | 17 |
| Ex-Smoker | 10 | 10 | 20 |
| Never Smoked | 8 | 7 | 15 |
2 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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