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 range
18 Years – 70 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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