Clinical Trial Details
| Trial ID: | L5082 |
| Source ID: | NCT02338921 |
| Associated Drug: | Sitagliptin |
| Title: | Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Sitagliptin|DRUG: Dapagliflozin|DRUG: Lobeglitazone|DRUG: Glimepirde|DRUG: Metformin |
| Outcome Measures: | Primary: Glycemic target goal achievement rate, HbA1c\< 7.0% without hypoglycemia, 24 months | Secondary: Beta-cell function, Beta-cell function, 6 and 24 months|insulin resistance, insulin resistance, 6 and 24 months|Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2), Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2), 3,6,9,12,16,20 and 24months|Lipid profile, Lipid profile, 3,6,9,12,16,20 and 24months|Body fat, Body fat, 6,12 and 24 months|urine microalbumin to creatinine ratio, urine microalbumin to creatinine ratio, 6,12 and 24 months|Change of HbA1c, Change of HbA1c, 3,6,9,12,16,20 and 24months|Glycemic target goal achievement rate, HbA1c\< 7.0% without hypoglycemia, 12 months | Other: hypoglycemia, hypoglycemia, 3,6,9,12,16,20 and 24months|body weight change, body weight change, 6 and 24 months |
| Sponsor/Collaborators: | Sponsor: Seoul National University Bundang Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 78 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-01 |
| Completion Date: | 2021-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2022-01-04 |
| Locations: | Soo Lim, Seongnam, Gyeonggi, 463-707, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02338921 |
