None listed
Conditions
Interventions
Drug : Intervention1: metformin extended release (ER) 1000mg, once daily for 3 months orally
Intervention2: metformin extended release (ER) 1000mg + gemigliptin 50mg fixed-dose combination, once daily
Sponsors
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person between the ages of 18 and 80 2) A person diagnosed with type 2 diabetes according to the diagnostic criteria of the Korean Diabetes Association by blood test 3) A person who has been diagnosed with type 2 diabetes within 2 years 4) A person who has not taken anti-diabetic medications in the past 8 weeks 5) A person with HbA1c of 6.5% or more and 8.5% or less at the screening visit 6) A person who has not changed their medications within 3 months of the screening visit 7) A person with an estimated glomerular filtration rate (CKD-EPI eGFR) of 60 ml/min/1.73m2 or more at the screening visit
Exclusion criteria
Exclusion criteria: 1) A person whose plasma glucose exceeds 270 mg/dl conducted after 8 hours of fasting 2) A person diagnosed with type 1 diabetes or other diabetes at the time of screening 3) A person with diabetic ketoacidosis at the time of screening 4) A person who has increased more than 3 times the upper limit of the normal range in any of the following in liver function test results performed at screening - Liver function test items: AST, ALT 5) A person who is judged to need systemic steroid treatment at the time of screening continuously 6) Patients with severe heart failure who are classified as Class III or higher by the New York Heart Association (NYHA). - New York Heart Association Classification of Heart Failure Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities. Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion. Class III: patients with marked limitations of activity; they are comfortable only at rest. Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on. 7) Pregnant and lactating women - However, women of childbearing age can participate only when it is certain that they are not pregnant. - Women of childbearing age are women who have not clearly reached menopause or have not been able to conceive due to surgical procedures. 8) A person who is undergoing medical treatment for moderate or severe gastrointestinal diseases based on screening criteria. - For example, gastric ulcer, inflammatory bowel disease, etc. 9) A person who has experienced cardiovascular events within 3 months of screening - Cardiovascular events: acute coronary artery disease, stroke, transient ischemic attack 10) A person who has participated in other clinical trials within 1 month of screening. - However, it is possible to participate in this clinical trial if there was no drug use as an observational study. 11) A person who is judged by the investigator to be inappropriate to participate in clinical trials for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of people who reached an HbA1c of less than 6.5% | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of HbA1c from the baseline;Change of the body weight from baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Han Choi
Konkuk University Medical Center
Outcome results
None listed