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Clinical Trial Details

Trial ID: L3028
Source ID: NCT02188186
Associated Drug: Initial Triple Combination
Title: Therapeutic Efficacy of Triple Combination in Drug-naïve Korean Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Initial triple combination|DRUG: Conventional treatment
Outcome Measures: Primary: Change of HbA1c, Therapeutic efficacy of triple combination of metform, sitagliptin, and lobeglitazone compared with sulfonylurea and metformin in drug-naïve Korean type 2 diabetic patients, 12 months | Secondary: beta-cell function, Changes of beta-cell function after one year treatment, 12 months|Insulin resistance, Changes of Insulin resistance after one year treatment, 12 months|Glucose homeostasis, Changes in fasting glucose concentration, 12 months|Glucose metabolism, Area under the curve of glucose during OGTT, 12 months|Glucose metabolism, Area under the curve of insulin during OGTT, 12 months|Microalbuminuria, urine microalbumin to creatinine ratio, 12 months|Lipid profile, Changes in TG/HDL/LDL-concentrations, 12 months | Other: Hypoglycemia, Incidence of hypoglycemia during study period, 12 months|Body weight, Changes of body weight after one year treatment, 12 months|Body composition, Changes of body composition after one year treatment, 12 months
Sponsor/Collaborators: Sponsor: Seoul National University Bundang Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-07
Completion Date: 2018-09
Results First Posted:
Last Update Posted: 2019-03-18
Locations: Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02188186

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress