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| ID | Type | Description | Link |
|---|---|---|---|
| 153097 | Registry Identifier | JAPIC-CTI |
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This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipragliflozin + Sitagliptin | Experimental | Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
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| Placebo + Sitagliptin | Active Comparator | Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipragliflozin | Drug | 50 mg tablet administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups. | Baseline and Week 24 |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 26 weeks |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG at Week 24 | Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033212 | Derived | Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15. |
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Prior to randomization, all participants received placebo for 2 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipragliflozin + Sitagliptin | Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| FG001 | Placebo + Sitagliptin | Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Placebo to ipragliflozin tablet administered orally |
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| Sitagliptin | Drug | Background medication; 50 mg tablet administered orally |
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| Baseline and Week 24 |
| Change From Baseline in 2-hr PMG at Week 24 | Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups. | Baseline and Week 24 |
| Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24 | Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups. | Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min) |
| Change From Baseline in Body Weight at Week 24 | Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups. | Baseline and Week 24 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipragliflozin + Sitagliptin | Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| BG001 | Placebo + Sitagliptin | Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| HbA1c | Mean | Standard Deviation | Percent |
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| Estimated Glomerular Filtration Rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
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| 2-hour Post-Meal Glucose (2-hr PMG) | Mean | Standard Deviation | mg/dL |
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| Glucose Total Area Under the Plasma Concentration Curve from Hour 0 to Hour 2 (AUC0-2hr) after Meal | Mean | Standard Deviation | mgï½¥hr/dL |
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| Body Weight | Mean | Standard Deviation | kg |
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| Prior use of other antihyperglycemic agents (AHAs) | Other AHAs refers to the use of AHAs other than sitagliptin within 8 weeks of study start. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in HbA1c at Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups. | All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
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| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | Up to 26 weeks |
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| Primary | Percentage of Participants Who Discontinued Study Drug Due to an AE | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | Up to 24 weeks |
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| Secondary | Change From Baseline in FPG at Week 24 | Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups. | All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
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| Secondary | Change From Baseline in 2-hr PMG at Week 24 | Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups. | All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
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| Secondary | Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24 | Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups. | All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mgï½¥hr/dL | Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min) |
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| Secondary | Change From Baseline in Body Weight at Week 24 | Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups. | All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of body weight after meal (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and Week 24 |
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Up to 26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipragliflozin + Sitagliptin | Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. | 2 | 73 | 12 | 73 | ||
| EG001 | Placebo + Sitagliptin | Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. | 4 | 70 | 15 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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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 must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Dvelopment | 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Male |
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| No |
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