Glucokinase Activator in Monogenic Diabetes

NCT06976658 | Recruiting Phase 2 DMC

• 1 other identifier: RESENSE
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus; Monogenic Diabetes

Keywords

GCK-MODY; glucokinase activator

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose

  Difference in fasting plasma glucose (FPG) between treatment periods

  8 weeks

Secondary Outcomes (6)

• • HbA1c

  8 weeks

• CGM metrics time in range

  8 weeks

• CGM metric coefficient of variation

  8 weeks

• Glucose area under the curve during OGTT

  8 weeks

• Insulin area under the curve during OGTT

  8 weeks

Other Outcomes (6)

• Treatment-emergent adverse events

  8 weeks

• Hypoglycemia

  8 weeks

• Blood pressure

  8 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

active drug or placebo in a cross over randomised sequence

Drug: Dorzagliatin

placebo

PLACEBO COMPARATOR

placebo in a cross over randomised sequence

Drug: matched placebo

Interventions

Dorzagliatin DRUG

Dorzagliatin 50mg bd

Intervention

matched placebo DRUG

matched placebo

placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and \<75 years
• body mass index (BMI) \>18 and \<30 kg/m2
• fasting plasma glucose \>5.6 mmol/L at screening
• 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) .

You may not qualify if:

• Body weight \<45kg at screening
• Current or planning pregnancy or lactating
• troke or cardiovascular disease within 6 months of recruitment
• severe renal dysfunction (estimated glomerular filtration rate \<30mL/min/1.73m2 or renal replacement therapy)
• severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \> 3 times upper limit of normal)
• history of drug abuse or excessive alcohol intake
• severe hypoglycemia within 6 months prior to screening
• anaemia with Hb \<10 g/dL at screening
• excessive blood loss \>300mL within 1 month of screening
• use of strong or moderate CYP3A4 inhibitors or inducers
• 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
• use of long-term high-dose corticosteroids at randomisation
• serious concurrent infections at time of screening

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

3M, Diabetes and Endocrine Research Center

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Elaine Chow, MD

CONTACT

+852 35051641; e.chow@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators, outcome assessors
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: May 16, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)