Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorElaine Chow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Dorzagliatin
Drugchronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: IH/T2DExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
At baseline and after 4 weeks of study drug treatmentSecondary outcomes
1
Second phase insulin secretion
The mean incremental insulin levels between 60 to 90 minutes of hyperglycemic clamp
Time frame
At baseline and after 4 weeks of study drug treatment2
Beta cell glucose sensitivity
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
Time frame
At baseline and after 4 weeks of study drug treatment3
Glucagon-like peptide -1 (GLP-1)
GLP-1 secretion Area under the curve (0-270 minute during hyperglyemic- OGTT clamp study)
Time frame
At baseline and after 4 weeks of study drug treatment4
Glucagon
Glucagon area under the curve (0-270 minute) during hyperglyemic- OGTT clamp
Time frame
At baseline and after 4 weeks of study drug treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Elaine Chow
Lead sponsor
Chinese University of Hong Kong
Sponsor institution
Source ClinicalTrials.gov
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