Dorzagliatin and 1st Phase Insulin and Beta-cell Glucose Sensitivity in IGT and NGT

NCT05468229 | Unknown Phase 1

• 1 other identifier: 2021.516-T
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dorzagliatin, a novel dual allosteric activator of glucokinase. reduces blood glucose by increasing insulin secretion by enhancing sensitivity of beta cells to glucose. In this placebo controlled cross over study, we examined the effects of dorzagliatin in people with impaired glucose tolerance and normal glucose tolerance.

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• 2-hour hyperglycemic clamp

  first phase insulin secretion

  2-hour

Study Arms (2)

dorzagliatin

ACTIVE COMPARATOR

Dorzagliatin 50 mg single dose

Drug: Dorzagliatin

placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

Dorzagliatin DRUG

single oral dose of dorzagliatin 50 mg

dorzagliatin

Placebo DRUG

Matching placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged ≥ 18 years but \< 65years
• Male or female
• Body mass index of over 18 kg/m2 and \< 30 kg/m2
• Fasting plasma glucose \<7.0 mmol/L and HbA1c \< 6.5%
• hour plasma glucose ≥7.8 and \<11.1 mmol/L on 75g oral glucose tolerance test (OGTT)
• Never been treated with glucose lowering drugs (including traditional Chinese medicine for glycemic control)
• Fasting plasma glucose \<5.6 mmol/L and HbA1c \< 5.7%
• hour plasma glucose \<7.8 mmol/L on 75g oral glucose tolerance test (OGTT)
• Never been treated with glucose lowering drugs (including traditional Chinese medicine for glycemic control

You may not qualify if:

• Subjects who do not agree to participate in this study.
• Country of birth is unknown.
• Body weight less than 45kg.
• 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 AST and/or 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.
• History of diabetes mellitus.
• Dehydration, diarrhoea or vomiting at the time of recruitment.
• Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.
• Subjects with anaemia (Haemoglobin \<11.0mg/dL or haematocrit \<0.35 ) at screening, known iron deficiency, haemoglobinopathies or anaemia due to chronic disease.
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind placebo controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share