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

March 1, 2025 updated by: Elaine Chow

Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elaine Chow
  • Phone Number: +852 35051642

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Additional inclusion criteria for IH group

  • 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

Additional inclusion criteria for T2D group

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IH/T2D
partipiants with intermediate hyperglycemia (IH) n=15 or T2D (n=15)
Drug: Dorzagliatin
chronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Insulin secretion
Time Frame: At baseline and after 4 weeks of study drug treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second phase insulin secretion
Time Frame: At baseline and after 4 weeks of study drug treatment
The mean incremental insulin levels between 60 to 90 minutes of hyperglycemic clamp
At baseline and after 4 weeks of study drug treatment
Beta cell glucose sensitivity
Time Frame: At baseline and after 4 weeks of study drug treatment
Beta cell glucose sensitivity will be calculated as increment of insulin secretion in 60-90 minutes of the clamp minus basal insulin divided by glucose change in the same period
At baseline and after 4 weeks of study drug treatment
Glucagon-like peptide -1 (GLP-1)
Time Frame: At baseline and after 4 weeks of study drug treatment
GLP-1 secretion Area under the curve (0-270 minute during hyperglyemic- OGTT clamp study)
At baseline and after 4 weeks of study drug treatment
Glucagon
Time Frame: At baseline and after 4 weeks of study drug treatment
Glucagon area under the curve (0-270 minute) during hyperglyemic- OGTT clamp
At baseline and after 4 weeks of study drug treatment
Incretin effect
Time Frame: At baseline and after 4 weeks of study drug treatment
Difference between the post prandial (100-270min) and preprandial (60-90min) C peptide response
At baseline and after 4 weeks of study drug treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elaine Chow

Investigators

  • Principal Investigator: Elaine Chow, MBChB, PhD, FRCP, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 1, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENSITISE-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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