Effects of Cofrogliptin on Beta-Cell Function in LADA Patients (NCT07460336) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
China84 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ketoac…
What they're measuring
1
Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Timeframe: Baseline, Week 52
Trial details
NCT IDNCT07460336
SponsorSecond Xiangya Hospital of Central South University