Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Xiangya Hospital of Central South University
About this trial
This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs \<0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Voluntarily signed informed consent.
2. Age 18 to 70 years, inclusive.
(1) Meets 1999 WHO criteria for diabetes mellitus.
(2) Age at diagnosis of diabetes ≥ 18 years.
Disqualifiers
1. Pregnant, breastfeeding, or planning to become pregnant during the study.
2. Gestational diabetes or other specific types of diabetes.
3. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.
4. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.
Trial design
Design model
Parallel
Treatments tested in this trial
Cofrogliptin
Drug5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.
Vitamin D3
Drug400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.
Metformin
DrugBackground therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment.
Insulin
DrugBackground therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Cofrogliptin + Vitamin D3 + Background TherapyExperimental treatment 4 interventions
Group B: Vitamin D3 + Background TherapyActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
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.
Time frame
Baseline, Week 52Secondary outcomes
1
Change From Baseline in 2-hour MMTT C-peptide AUC at Weeks 12, 26, and 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.
Time frame
Baseline, Week 12, Week 26, Week 382
Change From Baseline in Fasting C-peptide (FCP)
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.
Time frame
Baseline, Week 12, Week 26, Week 38, Week 523
Change From Baseline in 60-Minute Post-Meal C-peptide
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.
Time frame
Baseline, Week 12, Week 26, Week 38, Week 524
Change From Baseline in 120-Minute Post-Meal C-peptide
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.
Time frame
Baseline, Week 12, Week 26, Week 38, Week 52Other outcomes
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be evaluated by recording the number of participants who experience treatment-emergent adverse events and serious adverse events throughout the study, including events of special interest such as severe hypoglycemia and potential hypercalcemia.
Time frame
Throughout the study (52 weeks)2
Number of participants with Clinically Significant Abnormal Vital Signs, Laboratory Tests, or ECG Findings
Safety will be monitored by assessing the number (and proportion) of participants who experience clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, body temperature), clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), or 12-lead electrocardiogram (ECG) findings. Clinically significant changes will be evaluated by the investigator. Each participant will be counted once if any qualifying abnormality occurs.
Time frame
At scheduled visits through Week 52Sponsors and contacts
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Source ClinicalTrials.gov
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