Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

NCT ID: NCT06671340

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2026-01-31

Brief Summary

A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.

Conditions

Diabetes Mellitus; Prediabetes / Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IH/T2D

partipiants with intermediate hyperglycemia (IH) n=15 or T2D (n=15)

Group Type: EXPERIMENTAL

Dorzagliatin

Intervention Type: DRUG

chronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)

Interventions

Dorzagliatin

chronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Individuals aged ≥ 18 years but < 70 years

2. Male or female

3. Body mass index of over 18 kg/m2 and < 35 kg/m2

• Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
• 1 hour plasma glucose ≥8.6 and <11.6 mmol/L on 75g oral glucose tolerance test (OGTT)
• No use of glucose lowering drugs in past 6 months

• HbA1c 6.5 to 10% at screening
• On diet control, or stable dose of oral glucose lowering drugs metformin for at least 8 weeks

Exclusion Criteria

• 1. Subjects who do not agree to participate in this study. 2. Country of birth is unknown. 3. Body weight less than 45kg. 4. Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment).

5. Subjects with severe renal dysfunction as defined by eGFR <30 ml/min/1.73m2 or patients receiving renal dialysis (such as haemodialysis or continuous ambulatory peritoneal dialysis).

6. Severe hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times upper limit of normal.

7. Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months.

8. History of drug abuse or excessive alcohol intake based on investigator judgment.

9. Dehydration, diarrhoea or vomiting at the time of recruitment. 10. Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.

11. Subjects with anaemia (Haemoglobin <9.0mg/dL). 12. Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.

13. Participation in a clinical trial with investigational product within 30 days before enrolment.

14. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥300 mL of blood within 30 days prior to study drug administration.

15. Subjects judged unsuitable for the study based on investigator judgment. 16. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.

17. Unwilling or unable to follow protocol requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elaine Chow

OTHER

Sponsor Role: lead

Responsible Party

Elaine Chow

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elaine Chow, MBChB, PhD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Phase 1 Clinical Trial Centre

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Elaine Chow

Role: CONTACT

e.chow@cuhk.edu.hk

+852 35051641

Elaine Chow

Role: CONTACT

+852 35051642

Facility Contacts

Michelle Wong

Role: primary

michellewong27@cuhk.edu.hk

+852 35051641

Other Identifiers

SENSITISE-3

Identifier Type: -

Identifier Source: org_study_id