KCT0008078已完成未知
Establishment of initial treatment strategies individualized according to patient characteristics in newly diagnosed type 2 diabetes: Preliminary study
Seoul Metropolitan Government Seoul National University Boramae Medical Center0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
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’.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
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