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
Qualifiers
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
Treatments tested in this trial
- Cofrogliptin
- Vitamin D3
- Metformin
- Insulin
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov