NCT03088670已完成3 期
Evaluate Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- SatRx LLC
- 入组人数
- 299
- 试验地点
- 27
- 主要终点
- Mean change of HbA1c
研究概览
简要总结
To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline (Week 0).
详细描述
- Screening of patients at Week -2
- Training for all complying patients in Diabetes Program School at Week -1 with glucometer and patient diary distribution for SMBG
- Randomization in one of two groups in the ratio 1:1.
- The 1st stage includes 12 weeks of monotherapy with Gosogliptin or Vildagliptin.
- The 2nd stage includes 24 weeks of combination therapy with Gosogliptin and Metformin or Vildagliptin and Metformin.
- Follow-up period of 4 weeks.
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
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women from 18 through 78 years
- •Confirmed clinical diagnosis of type 2 diabetes mellitus
- •Drug-naive patients or patients without hypoglycemic drug treatment at least till 12 weeks before screening
- •Patient's agreed to use adequate methods of contraception during the study
- •Body mass index 22-40 kg/m2
- •HbA1c 7.5 - 11.0%
- •FPG < 15 mmol/L
- •Signed informed consent
- •Patient's ability to follow all protocol requirements
排除标准
- •Pregnancy and lactation, women who plan to become pregnant during the clinical study, women of child-bearing potential (i.e. non-stylized surgically and in period of post menopause less than 2 years) without adequate methods of contraception.
- •History of type 1 diabetes mellitus and other forms
- •Severe metabolic complications of diabetes as ketoacidosis, hyperosmolar coma during 6 weeks before screening
- •Severe complication of diabetes, for instance proliferative retinopathy in active stage, autonomic neuropathy or gastroparesis
- •A known allergy, hypersensitivity or contraindications to Gosogliptin, Vildagliptin, Metformin or their components
- •Convulsive disorder; system autoimmune diseases or vascular collagenosis demanding the previous or current treatment by systemic corticosteroids, cytostatics; malignancy within the last 5 years (except for a basal-cell carcinoma);
- •Significant cardiovascular diseases within 12 months of screening including: chronic heart failure of a class III or IV (NYHA), severe arrhythmia demanding treatment with antiarrhythmics, unstable angina, myocardial infarction, heart and coronary vessels surgery, heart valves diseases, transitory ischaemic attack or stroke, uncontrolled arterial hypertension with systolic Blood Pressure > 180 mm Hg and diastolic Blood Pressure > 110 mm Hg, pulmonary embolism or deep venous thrombosis
- •A nephrotic syndrome, a chronic renal failure, serum creatinine > 1.5 mg/dL (132 µmol/L) in men and > 1.4 mg/dL (123 µmol/L) in women or GFR <60 ml/min/1.73m2
- •HBV, HCV or a liver cirrhosis; AST or ALT > 3 ULN; total bilirubin > 2 ULN
- •HIV; severe infection that can affect glycemia within 30 days of screening
- •Anemia (Hb ≤10.5 g/dL in women or ≤11.5 g/dL in men); loss of > 1 unit of blood ( 500 mL) or blood transfusion within 12 weeks of screening
- •Drugs or alcohol abuse
- •Administration of any study drug within 30 days of screening
- •Inability to read or write; unwillingness to understand and follow the protocol procedures
研究组 & 干预措施
Gosogliptin treatment group
Experimental
12 weeks of monotherapy and 24 weeks of combination with Metformin
干预措施: Gosogliptin (Drug)
Gosogliptin treatment group
Experimental
12 weeks of monotherapy and 24 weeks of combination with Metformin
干预措施: Metformin (Drug)
Vildagliptin treatment group
Active Comparator
12 weeks of monotherapy and 24 weeks of combination with Metformin
干预措施: Vildagliptin (Drug)
Vildagliptin treatment group
Active Comparator
12 weeks of monotherapy and 24 weeks of combination with Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Mean change of HbA1c
时间窗: at Weeks 12 and 36 from baseline
Gosogliptin treatment group vs. Vildagliptin treatment group
次要结局
- HbA1c level of ≤7%(at Weeks 12 and 36 from baseline)
- Hypoglycemic episodes(up to 36 week)
- Fasting plasma glucose(at Weeks 12 and 36)
- Change of Body Mass(at Weeks 12 and 36)
- Adverse event(up to 40 week)
研究者
研究点 (27)
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