A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Comparator, Placebo-Controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 766
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c (%) compared to placebo comparator at week 24
研究概览
简要总结
This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce hemoglobin A1C levels in T2DM subjects.
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
- •Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
- •18 ≤ age ≤ 75 years old, male or female;
- •19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
- •Subjects with type 2 diabetes mellitus who did not regularly take oral hypoglycemic drugs at least 8 weeks before screening (i.e., continuous medication for <1 week);
- •7.0% ≤ HbA1c ≤ 9.5%;
- •Subjects voluntarily participate in the trial and sign the informed consent form;
- •Subjects agree to use contraception from the signing of the informed consent form to the end of 1 month of the last medication.
排除标准
- •FPG > 13.9 mmol/L;
- •A history of severe hypoglycemia (that is, hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
- •A history of allergy to similar drugs (DPP-4 inhibitors) or those who have been judged by the investigator to be allergic to tested drugs;
- •Uncured hyperthyroidism or other diseases may cause secondary blood sugar elevation;
- •Continuous use of glucocorticoids within 4 weeks prior to screening or may uninterrupted use glucocorticoids ≥14 days during the trial (except for external use and inhalation)
- •Subjects with chronic bowel disease associated with inflammatory bowel disease, partial intestinal obstruction, or obvious digestive and absorption disorders;
- •Subjects with infectious diseases(all positive for HBsAg, HBeAg, HBcAb, or positive for hepatitis C antibody, or positive for anti-HIV antibody); Female subjects of childbearing age are positive in pregnancy test or are lactating;
- •Subjects with a history of alcoholism or drug abuse;
- •Subjects have the clinically significant unstable diseases;
- •Not suitable for this clinical trial judged by the investigator.
研究组 & 干预措施
DRBP108
Phase A (Weeks 1-24): DBPR108 100mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
干预措施: DBPR108; Placebo matching sitagliptin (Drug)
Sitagliptin
Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
干预措施: Placebo matching DBPR108; Sitagliptin; DBPR108 (Drug)
Placebo
Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
干预措施: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108 (Drug)
结局指标
主要结局
Change from baseline in HbA1c (%) compared to placebo comparator at week 24
时间窗: Baseline, week 24
Change reflects the experimental value (baseline subtract) minus the placebo comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.
次要结局
- The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24(Week 24)
- Change from baseline in HbA1c (%) compared to active comparator at week 24(Baseline, week 24)
- The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52(Week 12, week 40, week 52)
- Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24(Baseline, week 12, week 24)
- Change from baseline in HbA1c (%) at week 12, week 40, week 52(Baseline, week 12, week 40, week 52)