Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 152867 | Registry Identifier | JAPIC-CTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 50 mg | Experimental | Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. |
|
| Glibenclamide 2.50 mg TDD | Active Comparator | Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 50 mg orally once a day before breakfast for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day -2) and Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29770541 | Derived | Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Screening for study inclusion was performed over a 4-week period. Adults with type 2 diabetes were randomized into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 50 mg | Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. |
| FG001 | Glibenclamide 2.50 mg TDD | Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 50 mg | Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. |
| BG001 | Glibenclamide 2.50 mg TDD | Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline (Day -2) and Day 13 |
|
Up to 4 weeks
The All Subjects as Treated (ASaT) population consisting of all participants who received at least one dose of study treatment was used for analysis of safety.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin 50 mg | Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periodontitis | Infections and infestations | MedDRA ver. 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Glibenclamide | Drug | Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days |
|
| 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. | 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. | 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. | Baseline (Day -2) and Day 13 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Duration of Diabetes Mellitus | Mean | Standard Deviation | Years |
|
| Smoking Status | Number | Participants |
|
| Alcohol Consumption | Number | Drinks/week |
|
| Hemoglobin A1C (HbA1C) | Glycosylated HbA1c is a surrogate marker of long-term glycemic control. The permissible range for study inclusion was ≥ 7.0% and < 9.0% (National Glycohemoglobin Standardization program; NGSP) at Week -2. | Mean | Standard Deviation | % |
|
| OG000 | Sitagliptin 50 mg | Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. |
| OG001 | Glibenclamide 2.50 mg TDD | Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. |
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline (Day -2) and Day 13 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline (Day -2) and Day 13 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline (Day -2) and Day 13 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Day -2) and Day 13 |
|
|
|
|
| 0 |
| 26 |
| 11 |
| 26 |
| EG001 | Glibenclamide 2.50 mg TDD | Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. | 0 | 26 | 10 | 26 |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA ver. 18.0 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA ver. 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA ver. 18.0 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA ver. 18.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential may be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Dinner |
|
| Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level. | constrained longitudinal analysis model | Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups. | 0.043 | LS Means Difference | -14.3 | 2-Sided | 95 | -28.1 | -0.5 | Superiority or Other |
| Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level. | constrained longitudinal analysis model | Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups. | 0.509 | LS Means Difference | 5.1 | 2-Sided | 95 | -10.3 | 20.4 | Superiority or Other |
| <50 mg/dL |
|
Comparison: Change in Baseline in Percentage of Hypoglycemic Values < 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.
| constrained longitudinal analysis model |
| 0.226 |
| LS Means Difference |
| -0.6 |
| 2-Sided |
| 95 |
| -1.5 |
| 0.4 |
| Superiority or Other |
| Comparison: Change in Baseline in Percentage of Hypoglycemic Values < 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level. | constrained longitudinal analysis model | 0.332 | LS Means Difference | 0.0 | 2-Sided | 95 | -0.1 | 0.0 | Superiority or Other |