New pill could help LADA patients keep making insulin longer
NCT ID NCT07460336
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug cofrogliptin to standard treatment (metformin, insulin, and vitamin D3) can help preserve beta-cell function in adults with latent autoimmune diabetes (LADA). Over 52 weeks, 84 participants will take either cofrogliptin or a placebo, and researchers will measure changes in insulin production using a mixed-meal test. The goal is to see if cofrogliptin can slow the loss of the body's ability to make insulin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cofrogliptin
- What this could lead to
- If it works, this could point toward a way to preserve insulin production in people with LADA, potentially delaying the need for insulin therapy.
- What could go wrong
- This is a small, early-stage trial with only 84 participants, and it is not yet recruiting. The results may not apply to all LADA patients, and the drug may not show significant benefit over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ketoacidosis (DKA) or hyperosmolar hyperglycemic state. * 10\. History of pancreatitis or pancreatic surgery. * 11\. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) \< 40%. * 12\. History of malignancy. * 13\. Severe psychiatric illness. * 14\. History of alcohol or illicit drug dependence. * 15\. Any other severe systemic disease that the investigator deems unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410000, China