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Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
Sponsor: Second Xiangya Hospital of Central South University
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.
Official title: Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-03-15
Completion Date
2027-12-31
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
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.
Locations (1)
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China