NCT07460336

Effects of Cofrogliptin on Beta-Cell Function in LADA Patients

Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Latent autoimmune diabetes in adults (LADA) is a form of autoimmune diabetes characterized by the progressive destruction of pancreatic beta cells. Preclinical and clinical evidence suggests that dipeptidyl peptidase-4 (DPP-4) inhibitors and vitamin D possess immunomodulatory effects that may help preserve residual beta-cell function. Cofrogliptin is a novel, ultra-long-acting DPP-4 inhibitor. This study will enroll patients with LADA who will first enter a screening period. Eligible participants will be randomized (1:1) into two parallel arms on Day 1. The experimental group will receive cofrogliptin and vitamin D3 in addition to their background therapy. The active comparator group will receive vitamin D3 plus background therapy. Background therapy includes metformin, with insulin permitted and adjusted per investigator's judgment. Follow-up clinic visits are scheduled at Weeks 12, 26, 38, and 52. Efficacy will be assessed through MMTT-derived C-peptide and glucose measurements, as well as other glycemic indices. Safety will be monitored through the recording of adverse events, laboratory tests, and vital signs throughout the 52-week treatment period.

Conditions

• Latent Autoimmune Diabetes in Adults (LADA)

Interventions

Type	Name	Description
DRUG	Cofrogliptin	5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.
DRUG	Vitamin D3	400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.
DRUG	Metformin	Background therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment.
DRUG	Insulin	Background therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-10
• Last updated: 2026-03-20

Locations

1 site across 1 country: China