Glucokinase Activator in Monogenic Diabetes (RESENSE)

The Chinese University of Hong Kong

Status and phase: Not yet enrolling; Phase 2

Conditions: Diabetes Mellitus; Monogenic Diabetes

Treatments: Drug: Dorzagliatin; Drug: matched placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06976658

RESENSE

Details and patient eligibility

About

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

Full description

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

active drug or placebo in a cross over randomised sequence

Treatment:

Drug: Dorzagliatin

placebo

Placebo Comparator group

Description:

placebo in a cross over randomised sequence

Treatment:

Drug: matched placebo