Type 2 DiabetesCARATNCT07122102
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
A study testing Cofrogliptin and Acarbose in people with Type 2 Diabetes, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cofrogliptin and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
He'nan Provincial People's Hospital
Zhengzhou, Henan
Xiaoyang Shi, ashi_1985@163.com
About this study
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Cofrogliptin, Acarbose
- Keywords
- cofrogliptin, acarbose, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CofrogliptinDrug
10mg administered once every two weeks
AcarboseDrug
50mg administered 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Cofrogliptin （HSK7653） | Experimental | Cofrogliptin tablets,10mg administered once every two weeks Receives: Drug: Cofrogliptin |
| Acarbose | Active comparator | Acarbose tablets, 50mg administered three times daily Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The difference in HbA1c from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (10)
FPG (Fasting plasma glucose)
The difference in FPG from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
2h-PPG (2-hour postprandial glucose)
The difference in 2h-PPG from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Fasting C-peptide
The difference in fasting C-peptide from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Insulin sensitivity
The difference in insulin sensitivity from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Islet function
The difference in Islet function from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Body weight
The difference in body weight from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Intestinal microbial composition and functional characteristics
The difference in intestinal microbial composition and functional characteristics from the baseline
Measured: From enrollment to the end of treatment at 12 weeks
Incidence of hypoglycemia
The percentage of subjects who experienced any investigator-defined hypoglycemic adverse event
Measured: From enrollment to the end of safety visitation at 13 weeks
Gastrointestinal adverse events
The percentage of subjects who experienced any investigator-defined gastrointestinal adverse events adverse event
Measured: From enrollment to the end of safety visitation at 13 weeks
Other adverse events
The percentage of subjects who experienced any investigator-defined adverse event
Measured: From enrollment to the end of safety visitation at 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122102
- Sponsor's protocol ID
- HSK7653-503
- Acronym
- CARAT
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07122102
- Acronym / sponsor ID
- CARAT / HSK7653-503
- Conditions
- Type 2 Diabetes
- Keywords
- cofrogliptin, acarbose, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cofrogliptin （HSK7653） | Experimental | Drug: CofrogliptinCofrogliptin tablets,10mg administered once every two weeks |
| Acarbose | Active comparator | Drug: AcarboseAcarbose tablets, 50mg administered three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cofrogliptin10mg administered once every two weeks | Drug | Cofrogliptin （HSK7653） |
| Acarbose50mg administered 3 times daily | Drug | Acarbose |
Primary outcome
HbA1c
Time frame: From enrollment to the end of treatment at 12 weeks
The difference in HbA1c from the baseline
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cofrogliptin and Acarbose in people with Type 2 Diabetes, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fangqiong Li (+86 028-67258, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.