Clinical Trial Details
| Trial ID: | L5835 |
| Source ID: | NCT02315287 |
| Associated Drug: | Pioglitazone |
| Title: | Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Pioglitazone|DRUG: Lobeglitazone |
| Outcome Measures: | Primary: Change of HbA1c, Comparison of therapeutic efficacy of two thiazolidinediones (Piogitazone vs. Lobeglitazone) in drug-naïve Korean type 2 diabetic patients, 5 and 12 months | Secondary: Beta-cell function, Changes of beta-cell function after 12 months treatment of triple combination, 12 months|Insulin resistance, Changes of insulin resistance after 12 months treatment of triple combination, 12 months|HbA1c < 7.0%, Comparision of glycemic control, 5 and 12 months|HbA1c =< 6.5%, Comparision of glycemic control, 5 and 12 months|FBS and PP2, Comparision of glycemic control, 5 and 12 months|microalbumin to creatinine ratio, Comparision of albumiuria, 5 and 12 months | Other: Hypoglycemia, Incidence of hypoglycemia in triple combination treatment, 12 months|Body weight, Changes of weight after 12months treatment of triple combination, 12 months |
| Sponsor/Collaborators: | Sponsor: Seoul National University Bundang Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 190 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-09 |
| Completion Date: | 2021-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2021-03-30 |
| Locations: | Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02315287 |
