Trial · NCT07460336
Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
NCT07460336, Not applicable, Not yet recruiting, Second Xiangya Hospital of Central South University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Cofrogliptin on Beta-Cell Function in LADA Patients. Trials, record NCT07460336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07460336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
- NCT number
- NCT07460336
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 84 participants, estimated
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Conditions
- Latent Autoimmune Diabetes in Adults (LADA)
- Interventions
- Cofrogliptin, Vitamin D3, Metformin, Insulin
- First posted
- 2026-03-10
- Last updated
- 2026-05-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) | Baseline, Week 52 | Change from baseline in the area under the curve from 0 to 120 minutes (AUC0-120) for serum C-peptide during a mixed-meal tolerance test (MMTT), calculated using the trapezoidal rule from C-peptide measured at 0, 60, and 120 minutes. |
| Secondary | Change From Baseline in 2-hour MMTT C-peptide AUC at Weeks 12, 26, and 38 | Baseline, Week 12, Week 26, Week 38 | The 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) will be calculated using the trapezoidal rule from C-peptide levels measured at 0, 60, and 120 minutes during the MMTT. Change from baseline is defined as the post-baseline value minus the baseline value. This outcome assesses the overall C-peptide response to a standardized meal stimulus. |
| Secondary | Change From Baseline in Fasting C-peptide (FCP) | Baseline, Week 12, Week 26, Week 38, Week 52 | Fasting C-peptide (FCP) is measured from a blood sample taken after an overnight fast of at least 8 hours. It reflects the basal insulin secretion capacity of pancreatic β-cells. |
| Secondary | Change From Baseline in 60-Minute Post-Meal C-peptide | Baseline, Week 12, Week 26, Week 38, Week 52 | Serum C-peptide will be measured at 60 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 60-minute C-peptide value minus the baseline 60-minute C-peptide value. This measurement assesses the early dynamic response of pancreatic β-cells to a meal stimulus. |
| Secondary | Change From Baseline in 120-Minute Post-Meal C-peptide | Baseline, Week 12, Week 26, Week 38, Week 52 | Serum C-peptide will be measured at 120 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 120-minute C-peptide value minus the baseline 120-minute C-peptide value. This measurement assesses the late dynamic response of pancreatic β-cells to a meal stimulus. |
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 26, Week 52 | HbA1c provides an indication of the average blood glucose levels over the preceding 2-3 months. This outcome measures the long-term glycemic control in participants. |
| Secondary | Proportion of Participants Achieving HbA1c < 7.0% | Week 12, Week 26, Week 38, Week 52 | The percentage of participants in each group who achieve a target HbA1c level of less than 7.0% (53 mmol/mol), which is a standard therapeutic goal for glycemic control in adults with diabetes. |
| Secondary | Change From Baseline in Mean Daily Insulin Dose | Baseline, Week 12, Week 26, Week 38, Week 52 | The change from baseline in the mean daily insulindose will be calculated as units per kilogram per day (u/kg/day), based on data recorded in participant diaries. This outcome is designed to evaluate the effect of the intervention on the requirement for exogenous insulin. |
| Secondary | Change From Baseline in Homeostatic Model Assessment of β-cell function (HOMA-β) | Baseline, Week 12, Week 26, Week 38, Week 52 | HOMA-β is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of basal pancreatic β-cell function. Change from baseline is defined as the post-baseline value minus the baseline value. |
| Secondary | Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, Week 12, Week 26, Week 38, Week 52 | HOMA-IR is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of insulin resistance. Change from baseline is defined as the post-baseline value minus the baseline value. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07460336
GET https://conductscience.org/api/trials/v1/NCT07460336/registered