Comparison on the efficacy of anti-diabetic drugs in patients with newly diagnosed type 2 diabetes
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008078
- Lead Sponsor
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
- Brief Summary
A total of 28 people were randomly assigned, 1 person dropped out, and all 27 participants completed the study. The study participants had a mean age of 60.2 years, body mass index of 25.7 kg/m2, HbA1c of 7.3%, and fasting plasma glucose concentration of 131 mg/dl. After 12 weeks of intervention, there were no statistically significant differences in most indicators between the ‘metformin monotherapy group’, ‘metformin + gemigliptin combination therapy group’, and ‘metformin + dapagliflozin combination therapy group’, but body weight in the 'metformin + dapagliflozin combination therapy group' had a statistically significantly greater decrease. The post-hoc analysis results showed that the ‘metformin + dapagliflozin combination therapy group’ had a statistically more significant weight loss compared to the ‘metformin monotherapy group’.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of people who reached an HbA1c of less than 6.5%
- Secondary Outcome Measures
Name Time Method Change of HbA1c from the baseline;Change of the body weight from baseline