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

NCT06671340 | Not Yet Recruiting DMC

• 1 other identifier: SENSITISE-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

clamp; diabetes; glucokinase activator

Outcome Measures

Primary Outcomes (1)

• Acute Insulin secretion

  Acute (first phase) insulin response (AIRg) to glucose will be calculated as the mean incremental responses above baseline (average of -20 and -10 and 0 minutes) to the samples drawn at 2, 4, 6, 8 and 10 minutes of the hyperglycemic clamp.

  At baseline and after 4 weeks of study drug treatment

Secondary Outcomes (5)

• Second phase insulin secretion

  At baseline and after 4 weeks of study drug treatment

• Beta cell glucose sensitivity

  At baseline and after 4 weeks of study drug treatment

• Glucagon-like peptide -1 (GLP-1)

  At baseline and after 4 weeks of study drug treatment

• Glucagon

  At baseline and after 4 weeks of study drug treatment

• Incretin effect

  At baseline and after 4 weeks of study drug treatment

Study Arms (1)

IH/T2D

EXPERIMENTAL

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

Drug: Dorzagliatin

Interventions

Dorzagliatin DRUG

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

IH/T2D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged ≥ 18 years but \< 70 years
• Male or female
• Body mass index of over 18 kg/m2 and \< 35 kg/m2
• Fasting plasma glucose \<7.0 mmol/L and HbA1c \< 6.5%
• 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

You may not qualify if:

• \. 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).
• \. 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).
• \. Severe hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times upper limit of normal.
• \. Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months.
• \. History of drug abuse or excessive alcohol intake based on investigator judgment.
• \. 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.
• \. 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.
• \. Participation in a clinical trial with investigational product within 30 days before enrolment.
• \. 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.
• \. Subjects judged unsuitable for the study based on investigator judgment. 16. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.
• \. Unwilling or unable to follow protocol requirements.

Sponsors & Collaborators

• Elaine Chow: lead

Study Sites (1)

Phase 1 Clinical Trial Centre

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

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

Study Officials

• Elaine Chow, MBChB, PhD, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Chow

CONTACT

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

Elaine Chow

CONTACT

+852 35051642

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: April 2, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 4, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)