An interventional study of Cofrogliptin and Vitamin D3 in Latent Autoimmune Diabetes in Adults (LADA), sponsored by Second Xiangya Hospital of Central South University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Second Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
Latent autoimmune diabetes in adults (LADA) is a form of autoimmune diabetes characterized by the progressive destruction of pancreatic beta cells. Preclinical and clinical evidence suggests that dipeptidyl peptidase-4 (DPP-4) inhibitors and vitamin D possess immunomodulatory effects that may help preserve residual beta-cell function. Cofrogliptin is a novel, ultra-long-acting DPP-4 inhibitor.
This study will enroll patients with LADA who will first enter a screening period. Eligible participants will be randomized (1:1) into two parallel arms on Day 1. The experimental group will receive cofrogliptin and vitamin D3 in addition to their background therapy. The active comparator group will receive vitamin D3 plus background therapy. Background therapy includes metformin, with insulin permitted and adjusted per investigator's judgment. Follow-up clinic visits are scheduled at Weeks 12, 26, 38, and 52. Efficacy will be assessed through MMTT-derived C-peptide and glucose measurements, as well as other glycemic indices. Safety will be monitored through the recording of adverse events, laboratory tests, and vital signs throughout the 52-week treatment period.
Second Xiangya Hospital of Central South University is the lead sponsor of 82 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Cofrogliptin (10 mg orally every 2 weeks) and Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), over a period of 52 weeks.
Drug: Cofrogliptin · Drug: Vitamin D3 · Drug: Metformin · Drug: Insulin
Participants will receive Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), for a total duration of 52 weeks.
Drug: Vitamin D3 · Drug: Metformin · Drug: Insulin
5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.
400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.
Background therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment.
Background therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.
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 52
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 38
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 52
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 52
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 52
Change From Baseline in Glycated Hemoglobin (HbA1c)
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.
Time frame: Baseline, Week 26, Week 52
Proportion of Participants Achieving HbA1c < 7.0%
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.
Time frame: Week 12, Week 26, Week 38, Week 52
Change From Baseline in Mean Daily Insulin Dose
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.
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of β-cell function (HOMA-β)
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.
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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.
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Glutamic Acid Decarboxylase Autoantibody (GADA) Titers
GADA is a marker of the autoimmune process in LADA. Change from baseline is defined as the Week 52 value minus the baseline value. Changes in its titers may reflect modulation of the autoimmune response.
Time frame: Baseline, Week 52
Change From Baseline in Insulinoma-Associated Antigen-2 Autoantibody (IA-2A) Titers
IA-2A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value.
Time frame: Baseline, Week 52
Change From Baseline in Zinc Transporter 8 Autoantibody (ZnT8A) Titers
ZnT8A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value.
Time frame: Baseline, Week 52
Change From Baseline in Body Weight
Body weight will be measured in kilograms (kg) at scheduled visits. Change from baseline is defined as the post-baseline value minus the baseline value.
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m²) to assess changes in body composition. Change from baseline is defined as the post-baseline value minus the baseline value.
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
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)
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 52
Plan to share: No
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Latent Autoimmune Diabetes in Adults
Second Xiangya Hospital of Central South University