NCT07122102尚未招募不适用
A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes
详细描述
This study will enroll treatment-naïve patients with type 2 diabetes who meet inclusion criteria, and randomize them 1:1 to either the coglitin treatment group or the acarbose treatment group for a 12-week open-label parallel-controlled treatment period, with the coglitin group receiving 10mg coglitin tablets once every two weeks and the acarbose group receiving 50mg acarbose tablets three times daily; the primary endpoint is the change in glycated hemoglobin (HbA1c) from baseline at week 12, followed by a 1-week safety follow-up visit after treatment completion, with study conclusion upon completion of this safety visit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Capable of understanding and voluntarily signing the written informed consent form.
- •2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications.
- •5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol/L. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg/m². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period.
排除标准
- •1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients.
- •2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy.
- •3.Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent.
- •4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP >3×ULN at screening. 7.Severe renal impairment (eGFR <25 mL/min/1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration).
- •10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years.
- •11.Anti-obesity medications within 3 months prior to consent or weight instability at screening.
- •12.Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy.
- •13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).
- •16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM).
- •17.Substance abuse within 3 months or chronic conditions potentially compromising compliance.
- •18.Pregnancy, lactation, or unwillingness to use effective contraception (females/males).
- •19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.
研究组 & 干预措施
Cofrogliptin （HSK7653）
Experimental
Cofrogliptin tablets,10mg administered once every two weeks
干预措施: Cofrogliptin (Drug)
Acarbose
Active Comparator
Acarbose tablets, 50mg administered three times daily
干预措施: Acarbose (Drug)
结局指标
主要结局
HbA1c
时间窗: From enrollment to the end of treatment at 12 weeks
The difference in HbA1c from the baseline
次要结局
- FPG (Fasting plasma glucose)(From enrollment to the end of treatment at 12 weeks)
- 2h-PPG (2-hour postprandial glucose)(From enrollment to the end of treatment at 12 weeks)
- Fasting C-peptide(From enrollment to the end of treatment at 12 weeks)
- Insulin sensitivity(From enrollment to the end of treatment at 12 weeks)
- Islet function(From enrollment to the end of treatment at 12 weeks)
- Body weight(From enrollment to the end of treatment at 12 weeks)
- Intestinal microbial composition and functional characteristics(From enrollment to the end of treatment at 12 weeks)
- Incidence of hypoglycemia(From enrollment to the end of safety visitation at 13 weeks)
- Gastrointestinal adverse events(From enrollment to the end of safety visitation at 13 weeks)
- Other adverse events(From enrollment to the end of safety visitation at 13 weeks)
研究者
研究点 (1)
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