A Phase IIA , Multi-center, Randomized, Double-blind, Placebo and Positive Drug Parallel Control Study of TQ-F3083 Capsules With Different Doses in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
TQ-F3083 capsule is a new type inhibitor of DPP-IV, which is currently a very effective target for the treatment of type 2 diabetes mellitus at clinical. In addition, it can promote insulin secretion with low potential toxicity, and half-life is shorter than Linagliptin.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Understood and signed an informed consent form; 2.18 and 70 years old; 3.Body mass index (BMI) of 19 to 37.5 kg/m2; 4.Type 2 diabetes mellitus confirmed at least 6 weeks before screen by WHO (1999) diabetes mellitus diagnostic criteria; 5.Has inadequate glycemic control on diet/exercise therapy and irregular use hypoglycemic agents before screening, HbA1c ≥7.0% and ≤10.0% ; Has regular hypoglycemic agents with stable dose within 6 weeks before screening, HbA1c ≥7.0% and ≤9 %; 6.PFG ≤ 13.3 mmol / L;
- •Adequate laboratory inspection standards.
排除标准
- •Has any contraindications, allergies or hypersensitivity for taking research medication ;
- •Has used at lest two oral medications to treat diabetes mellitus 6 weeks before screening;
- •Has other endocrine-related history or evidence before screening;
- •Has history of organ transplantation;
- •Has mental or neurological diseases;
- •Has received systemic corticosteroids within 2 weeks;
- •Has received GLP-1 analogues, DPP-4 inhibitors or anti-obesity drugs 3 months ;
- •Has alcohol abuse history within 6 months before screening;
- •Has participated in any clinical trial within 3 months;
- •Has received blood transfusions, or blood donation ≥ 400 mL , or got severe blood loss ≥ 400 mL within 8 weeks;
- •Pregnant or lactating woman.
研究组 & 干预措施
Low dose group
Subjects in the low dose group administrated one TQ-F3083 capsule 10mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: TQ-F3083 capsule 10 mg (Drug)
Low dose group
Subjects in the low dose group administrated one TQ-F3083 capsule 10mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: TQ-F3083 blank analog capsule (Drug)
Low dose group
Subjects in the low dose group administrated one TQ-F3083 capsule 10mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: Linagliptin blank analog tablet (Drug)
High dose group
Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: TQ-F3083 capsule 20 mg (Drug)
High dose group
Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: Linagliptin blank analog tablet (Drug)
Positive drug control group
Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks.
干预措施: TQ-F3083 blank analog capsule (Drug)
Positive drug control group
Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks.
干预措施: Linagliptin tablet (Drug)
Placebo group
Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: TQ-F3083 blank analog capsule (Drug)
Placebo group
Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
干预措施: Linagliptin blank analog tablet (Drug)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: up to approximately 15 weeks
Changes in HbA1c compared with baseline after 12 weeks of treatment
次要结局
- Fasting plasma glucose (FPG)(up to approximately 15 weeks)
- HbA1c(up to approximately 15 weeks)
- 2 hours-postprandial blood sugar (2h-PPG）(up to approximately 15 weeks)
- Weight(up to approximately 7, 11, 15 weeks)
- DPP-4 activity ( dipeptidyl peptidase-4)(baseline up to 4, 8, 12 weeks)
- GLP-1 (glucagon-like peptide-1)(baseline up to 4, 8, 12 weeks)