Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 153083 | Registry Identifier | JAPIC-CTI | |
| MK-0431J-849 | Other Identifier | Merck |
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 to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipragliflozin | Experimental | Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipragliflozin | Drug | one 50 mg tablet QD |
| |
| Sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) | An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded. | Up to 54 weeks |
| Percentage of Participants Who Had Study Drug Discontinued Due to an AE | The percentage of participants who had study treatment stopped due to an AE regardless if they completed study. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c | Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage. | Baseline and Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 |
|---|---|---|---|
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ipragliflozin | Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ipragliflozin | Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy. |
| 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 | Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) | An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded. | All participants who received at least 1 dose of treatment period study medication. | Posted | Number | Percentage of participants | Up to 54 weeks |
|
Up to 54 weeks
All participants that received at least 1 dose of study drug.
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 | Ipragliflozin 50 mg | Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | 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 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2015 | Feb 16, 2018 | Prot_SAP_000.pdf |
| 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 |
|---|---|
| C572941 | ipragliflozin |
| D000068900 | Sitagliptin Phosphate |
| 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
| Drug |
one 50 mg tablet QD |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | Percentage |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants Who Had Study Drug Discontinued Due to an AE | The percentage of participants who had study treatment stopped due to an AE regardless if they completed study. | All participants who received at least 1 dose of treatment period study medication. | Posted | Number | Percentage of Participants | Up to 52 weeks |
|
|
|
| Secondary | Change From Baseline in HbA1c | Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage. | All participants who received at least 1 dose of treatment period study medication. had at least 1 measurement of the outcome variable (baseline or post-baseline) and had baseline data for those analyses that required baseline data. | Posted | Mean | 95% Confidence Interval | Percent | Baseline and Week 52 |
|
|
|
| 0 |
| 77 |
| 5 |
| 77 |
| 44 |
| 77 |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 19.1 | 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 must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |