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| ID | Type | Description | Link |
|---|---|---|---|
| TOFOGL07279 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofogliflozin +GLP-1 analogue | Experimental | Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofogliflozin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction | baseline and Week 52 | |
| Change from Baseline in HbA1c at 52 weeks | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting plasma glucose | baseline and week 52 | |
| Change in Body Weight | baseline and week 52 | |
| Change in Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atsuta-ku | Aichi-ken | 456-0058 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033218 | Result | Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C575086 | 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol |
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| GLP-1 analogue |
| Drug |
|
| baseline and week 52 |
| Change in Uric Acid | baseline and week 52 |
| Change in Total cholesterol | baseline and week 52 |
| Change in HDL-C | baseline and week 52 |
| Change in LDL-C | baseline and week 52 |
| Change in non HDL-C | baseline and week 52 |
| Change in Free Fatty Acid | baseline and week 52 |
| Minato-ku |
| Aichi-ken |
| 455-0018 |
| Japan |
| Kisarazu | Chiba | 292-0038 | Japan |
| Annaka | Gunma | 379-0116 | Japan |
| Naka | Ibaraki | 311-0113 | Japan |
| Sagamihara | Kanagawa | 252-0302 | Japan |
| Kasaoka | Okayama-ken | 714-0043 | Japan |
| Shimono | Tochigi | 329-0433 | Japan |
| Adachi-ku | Tokyo | 123-0845 | Japan |
| Chuo-ku | Tokyo | 103-0027 | Japan |
| Mitaka | Tokyo | 181-0013 | Japan |
| D004700 | Endocrine System Diseases |