NCT04218734已完成3 期
A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2020年1月14日最近更新:
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
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Change in HbA1c (%) from baseline to week 24
研究概览
简要总结
This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;
- •Age 18-75 years, men and women;
- •BMI 19-35 kg/m2;
- •HbA1c 7.0%-9.5%;
- •Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.
- •Signed informed consent from the patient;
- •Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.
排除标准
- •FPG > 13.9 mmol/L;
- •Insulin treatment required in the investigator's opinion;
- •Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;
- •Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- •Severe hypoglycemia;
- •Serious diabetic complications (such as diabetic foot, etc.);
- •History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
- •History of being allergic to DPP-4 inhibitors;
- •Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;
- •Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;
- •Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;
- •Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3*upper limit of normal (ULN), or total bilirubin > 1.5ULN;
- •Abnormal renal function;
- •White blood cells (WBC) < 3.0109/l, neutrophil count of peripheral blood < 1.5109/l, hemoglobin < 100g / L, triglyceride > 5.7 mmol/l;
- •HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;
- •Pregnant or lactating women;
- •History of alcohol or drug abuse;
- •Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;
- •Significant unstable diseases;
- •Any condition that in the investigator's opinion might render the patient unable to participate the trial.
研究组 & 干预措施
metformin hydrochloride+DBPR108
Experimental
metformin hydrochloride 500 mg+DBPR108 100 mg
干预措施: metformin hydrochloride (Drug)
metformin hydrochloride+DBPR108
Experimental
metformin hydrochloride 500 mg+DBPR108 100 mg
干预措施: DBPR108 (Drug)
metformin hydrochloride+placepo
Placebo Comparator
metformin hydrochloride 500 mg+placebo 100 mg
干预措施: metformin hydrochloride (Drug)
metformin hydrochloride+placepo
Placebo Comparator
metformin hydrochloride 500 mg+placebo 100 mg
干预措施: placepo (Drug)
结局指标
主要结局
Change in HbA1c (%) from baseline to week 24
时间窗: baseline, 24 weeks
The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo
次要结局
- Percentage of HbA1c ≤ 6.5%(24 weeks)
- Percentage of HbA1c ≤ 7%(24 weeks)
- Change in HbA1c (%) from baseline to week 12(baseline, 12 weeks)
- Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24(Baseline, 12 weeks and 24 weeks)
- Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24(Baseline, 12 weeks and 24 weeks)
- Change in body weight from baseline to week 12 and week 24(Baseline, 12 weeks and 24 weeks)
研究者
研究点 (1)
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