Effects of Cofrogliptin on Beta-Cell Function in LADA Patients

NCT07460336 · tracked via the Priya Life Science China tracker

Sponsor

Second Xiangya Hospital of Central South University

Phase

Not applicable

Started

2026-05-15

Last updated

2026-05-08

Condition(s) studied

Latent Autoimmune Diabetes in Adults (LADA)

Investigational drug(s) / intervention(s)

Cofrogliptin →Vitamin D3 →Metformin →Insulin

Cofrogliptin: 5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.

Vitamin D3: 400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.

Metformin: Background therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment.

Insulin: Background therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 1\. Voluntarily signed informed consent. * 2\. Age 18 to 70 years, inclusive. * 3\. Diagnosed with LADA, defined as meeting all of the following: * (1) Meets 1999 WHO criteria for diabetes mellitus. * (2) Age at diagnosis of diabetes ≥ 18 years. * (3) Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A). * (4) Did not require continuous insulin therapy for at least 6 months after diagnosis. * 4\. Stimulated C-peptide ≥ 200 pmol/L. * 5\. Glycated Hemoglobin (HbA1c) ≤ 9.0%. * 6\. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study. Exclusion Criteria: * 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. * 5\. Hypercalcemia (serum calcium above the upper limit of the normal range). * 6\. Systemic corticosteroid therapy (oral or IV) for more than 7 consecutive days within 6 months prior to screening. * 7\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal (ULN), or total bilirubin \> 2 times ULN. * 8\. Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m². * 9\. History of acute diabetic complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state. * 10\. History of pancreatitis or pancreatic surgery. * 11\. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) \< 40%. * 12\. History of malignancy. * 13\. Severe psychiatric illness. * 14\. History of alcohol or illicit drug dependence. * 15\. Any other severe systemic disease that the investigator deems unsuitable for enrollment.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
The Second Xiangya Hospital, Central South University	Changsha	Hunan

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07460336 on ClinicalTrials.gov ↗ ← All trials in China