Glucokinase Activator in Monogenic Diabetes

NCT ID: NCT06976658

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-12-31

Brief Summary

Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

Detailed Description

Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

Conditions

Diabetes Mellitus; Monogenic Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

active drug or placebo in a cross over randomised sequence

Group Type: ACTIVE_COMPARATOR

Dorzagliatin

Intervention Type: DRUG

Dorzagliatin 50mg bd

placebo

placebo in a cross over randomised sequence

Group Type: PLACEBO_COMPARATOR

matched placebo

Intervention Type: DRUG

matched placebo

Interventions

Dorzagliatin

Dorzagliatin 50mg bd

Intervention Type: DRUG

matched placebo

matched placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 and <75 years

2. body mass index (BMI) >18 and <30 kg/m2

3. fasting plasma glucose >5.6 mmol/L at screening

4. Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) .

Exclusion Criteria

1. Body weight <45kg at screening

2. Current or planning pregnancy or lactating

3. troke or cardiovascular disease within 6 months of recruitment

4. severe renal dysfunction (estimated glomerular filtration rate <30mL/min/1.73m2 or renal replacement therapy)

5. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase > 3 times upper limit of normal)

6. history of drug abuse or excessive alcohol intake

7. severe hypoglycemia within 6 months prior to screening

8. anaemia with Hb <10 g/dL at screening

9. excessive blood loss >300mL within 1 month of screening

10. use of strong or moderate CYP3A4 inhibitors or inducers

11. use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation

12. use of long-term high-dose corticosteroids at randomisation

13. serious concurrent infections at time of screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Elaine Chow

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

3M, Diabetes and Endocrine Research Center

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Elaine Chow, MD

Role: CONTACT

e.chow@cuhk.edu.hk

+852 35051641

Shun Ling KONG, MSc

Role: CONTACT

slkong@cuhk.edu.hk

+85235051648

Facility Contacts

Shun Ling KONG, MSc

Role: primary

slkong@cuhk.edu.hk

+852 35052648

Other Identifiers

RESENSE

Identifier Type: -

Identifier Source: org_study_id