Clinical Trial Details
| Trial ID: | L0478 |
| Source ID: | JPRN-jRCTs031180159 |
| Associated Drug: | Pioglitazone |
| Title: | Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes. Randomized, open label pilot study. - ToPiND study |
| Acronym: | -- |
| Status: | Not Recruiting |
| Study Results: | Has Results |
| Results: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888333/ |
| Conditions: | Type 2 Diabetes, NAFLD <br>Diabetes, NAFLD |
| Interventions: | Arm A:Tofogliflozin 20mg <Time Frame: 0 to 24 weeks> , Tofogliflozin 20mg + Pioglitazone 15-30mg <Time Frame: 24 to 48 weeks><br>Arm B: Pioglitazone 15-30mg <Time Frame: 0 to 24 weeks>, Tofoglifozin 20mg + Pioglitazone 15-30mg <Time Frame: 24 to 48 weeks> |
| Outcome Measures: | Change in liver fat content as measured by MRI-based proton density fat fraction (PDFF). <Time Frame: 24 weeks>1)Important secondary outcome<br>Change in serum ALT level. <Time Frame: 24 weeks> <br><br>2)other secondary outcomes <br><1> <br>Secondary outcomes during randomization phase (mono-therapy), <Time Frame: 0 to 24 weeks >; <br>% change in liver fat by MRI-PDFF., >=10%, >=20% and >=30% reduction of MRI-PDFF., change in liver stiffness by MR elastography., >=5%, >=10% and >=15% reduction of liver stiffness., change in HbA1c, glucose, insulin, and HOMA-R., change in body weight and BMI., change in ALT, AST, gamma-GTP, ALP, total bilirubin and ALT/AST ratio., the proportion of normalization of ALT and AST level., platelet count, total protein albumin and choline esterase and ferritin., type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, and urinary 8-OHdG., number(%) of adverse event. <br><2> <br>Secondary outcomes during combination therapy phase <Time Frame: 24 to 48weeks>; liver fat content, liver stiffness, HbA1c, glucose, insulin, HOMA-R., body weight, BMI, ALT, AST, gamma-GTP, ALP, total bilirubin, ALT/AST ratio., the proportion of normalization of ALT and AST level, platelet count, total protein albumin and choline esterase, ferritin, type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, urinary 8-OHdG., number(%) of adverse event. |
| Sponsor/Collaborators: | Yoneda Masato |
| Gender: | All |
| Age: | >= 20age old<= 74age old |
| Phases: | Not applicable |
| Enrollment: | 40 |
| Study Type: | Interventional |
| Study Designs: | randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose |
| Start Date: | 26/02/2019 |
| Completion Date: | 27/11/2020 |
| Results First Posted: | 16/09/2021 |
| Last Update Posted: | 10 January 2022 |
| Locations: | Japan |
| URL: | https://jrct.niph.go.jp/latest-detail/jRCTs031180159 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D275 | Pioglitazone | Chemical drug | DB01132 | PPARG agonist | Improve insulin resistance | Advanced in clinical trials | Details |
| D018 | Aspirin | Chemical drug | DB00945 | AKR1C1 inhibitor; PCNA downregulator | Enhance lipid metabolism | Under clinical trials | Details |
| D075 | Choline | Supplement | DB00122 | PLD2 product of; PLD1 product of | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |
| D372 | Tofogliflozin | Chemical drug | DB11824 | SGLT2 inhibitor | Improve insulin resistance | Under clinical trials | Details |