Type 2 Diabetes Clinical Trial
Official title:
Comparison of Therapeutic Efficacy Between Lobeglitazone and Pioglitazone as Initial Triple Therapy With Metformin and Sitagliptin in Drug-naïve Type 2 Diabetic Patients
Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - HbA1c > 13.0 % - No treatment with insulin or oral agents for 6 months - 20 = Age < 80 years Exclusion Criteria: - Contraindication to sitagliptin or metformin or thiazolidinedione - Pregnant or breast feeding women - Type 1 diabetes, gestational diabetes, or secondary forms of diabetes - Not appropriate for oral antidiabetic agent - Medication which affect glycemic control - Disease which affect efficacy and safety of drugs - Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hypoglycemia | Incidence of hypoglycemia in triple combination treatment | 12 months | |
Other | Body weight | Changes of weight after 12months treatment of triple combination | 12 months | |
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 | |
Secondary | Insulin resistance | Changes of insulin resistance after 12 months treatment of triple combination | 12 months | |
Secondary | HbA1c < 7.0% | Comparision of glycemic control | 5 and 12 months | |
Secondary | HbA1c =< 6.5% | Comparision of glycemic control | 5 and 12 months | |
Secondary | FBS and PP2 | Comparision of glycemic control | 5 and 12 months | |
Secondary | microalbumin to creatinine ratio | Comparision of albumiuria | 5 and 12 months |
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