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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cofrogliptin, Acarbose.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes
Detailed description
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.
Interventions
- Drug Cofrogliptin
10mg administered once every two weeks - Drug Acarbose
50mg administered 3 times daily
Primary outcome measures
- HbA1c [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (10)
- FPG (Fasting plasma glucose) [Time frame: From enrollment to the end of treatment at 12 weeks]
- 2h-PPG (2-hour postprandial glucose) [Time frame: From enrollment to the end of treatment at 12 weeks]
- Fasting C-peptide [Time frame: From enrollment to the end of treatment at 12 weeks]
- Insulin sensitivity [Time frame: From enrollment to the end of treatment at 12 weeks]
- Islet function [Time frame: From enrollment to the end of treatment at 12 weeks]
- Body weight [Time frame: From enrollment to the end of treatment at 12 weeks]
- Intestinal microbial composition and functional characteristics [Time frame: From enrollment to the end of treatment at 12 weeks]
- Incidence of hypoglycemia [Time frame: From enrollment to the end of safety visitation at 13 weeks]
- Gastrointestinal adverse events [Time frame: From enrollment to the end of safety visitation at 13 weeks]
- Other adverse events [Time frame: From enrollment to the end of safety visitation at 13 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- He'nan Provincial People's Hospital — Zhengzhou
Identifiers
NCT: NCT07122102 · HSK7653-503