Clinical Trial Details
| Trial ID: | L3949 |
| Source ID: | NCT04013581 |
| Associated Drug: | Tzd Group |
| Title: | Quadruple Oral Combination Therapy for Type 2 Diabetes Mellitus : Glycemic Control by Thiazolidinedione (TZD) or Sodium Glucose Co-transporter 2 (SGLT-2) Inhibitor as an add-on Therapy in Type 2 Diabetes Mellitus After Failure of an Oral Triple Antidiabetic Regimen |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: TZD group|DRUG: SGLT-2 group |
| Outcome Measures: | Primary: Change of HbA1c, 12 weeks|Change of HbA1c, Mean difference of HbA1c after 24 week-treatment, 24 weeks | Secondary: glucose, Percentage of patients who achieve target HbA1c (≤7% level), 12 weeks|glucose, Mean difference of fasting blood glucose after 24 week-treatment, 24 weeks|Adverse events, Incidence of adverse events during treatment period, 12 weeks|Adverse events, Incidence of adverse events during treatment period, 24 weeks|Change of kidney function, Mean change of BUN and serum creatinine, 12 weeks|Change of kidney function, Mean change of BUN and serum creatinine, 24 weeks|Change of liver enzymes, Mean change of AST(Asparate aminotransferase), 12 weeks|Change of liver enzymes, Mean change of ALT(Alanine aminotransferase), 12 weeks|Change of liver enzymes, Mean change of Total bilirubin, 12 weeks|Change of liver enzymes, Mean change of AST, 24 weeks|Change of liver enzymes, Mean change of ALT, 24 weeks|Change of liver enzymes, Mean change of Total bilirubin, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Yonsei University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 121 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-08-05 |
| Completion Date: | 2020-05-28 |
| Results First Posted: | |
| Last Update Posted: | 2021-05-04 |
| Locations: | Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT04013581 |
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