Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
研究概览
简要总结
To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.
详细描述
This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.
Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg.
Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
- •Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
- •Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
- •Written informed consent
- •WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- •WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- •WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
排除标准
- •Type 1 diabetes or history of diabetic ketoacidosis
- •Pregnant or breast-feeding patients
- •eGFR < 60 mL/min/1.73 m2 (MDRD) on visit
- •Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit
- •Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
- •Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
- •History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- •History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
- •History of alcohol or drug abuse judged by physician within 3 months prior to randomization
- •Concomitant participation in any other clinical study.
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10mg + Metformin 1000mg
干预措施: Dapagliflozin (Drug)
Glimepiride
Glimepiriide 1-2mg + Metformin 1000mg
干预措施: Glimepiride (Drug)
结局指标
主要结局
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
时间窗: From baseline to Week 52
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
时间窗: From baseline to Week 52
Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
次要结局
- Adjusted Mean Change in Waist Circumference at Week 52(From baseline to Week 52)
- HbA1c <7.0% at Week 52(52 weeks)
- Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52(From baseline to Week 52)
- Adjusted Mean Change in HbA1c at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Total Body Weight at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Body Mass Index (BMI) at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Adinopectin at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52(From baseline to Week 52)
- Adjusted Mean Change in Lean Body Mass at Week 52(From baseline to Week 52)
- Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52(From baseline to Week 52)