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

Обзор

This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes

Подробное описание

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.

Вмешательства

• Препарат Cofrogliptin
  10mg administered once every two weeks
• Препарат Acarbose
  50mg administered 3 times daily

Первичные конечные точки

• HbA1c [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (10)

• FPG (Fasting plasma glucose) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• 2h-PPG (2-hour postprandial glucose) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Fasting C-peptide [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Insulin sensitivity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Islet function [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Body weight [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Intestinal microbial composition and functional characteristics [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Incidence of hypoglycemia [Срок оценки: From enrollment to the end of safety visitation at 13 weeks]
• Gastrointestinal adverse events [Срок оценки: From enrollment to the end of safety visitation at 13 weeks]
• Other adverse events [Срок оценки: From enrollment to the end of safety visitation at 13 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• He'nan Provincial People's Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT07122102 · HSK7653-503

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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