A Phase 2, Multicentre, Open-Label Study to Evaluate the Efficacy, Safety, and Beta-Cell Preserving Effects of MTF-3110 in Adults with Latent Autoimmune Diabetes in Adults (LADA)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000382370

Enrollment

120

Registered

2026-03-27

Start date

2026-04-30

Completion date

2027-03-31

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is investigating whether the medicine exenatide (MTF-3110) can help preserve the body’s natural insulin production in people with latent autoimmune diabetes in adults (LADA). LADA is a form of diabetes in which the immune system gradually damages the insulin-producing cells of the pancreas. Over time, this leads to reduced insulin production and the need for insulin therapy. Exenatide is a medication that mimics a natural hormone called GLP-1, which helps regulate blood sugar levels by increasing insulin release when glucose levels are high, slowing stomach emptying, and reducing appetite. Researchers believe that treatment with exenatide may help protect or preserve the remaining insulin-producing cells in people with LADA. In this study, participants will receive exenatide injections twice daily for 26 weeks. Researchers will measure how well the pancreas produces insulin using a mixed meal tolerance test, as well as monitor blood glucose levels, diabetes control, and safety outcomes during the study. The main hypothesis is that treatment with exenatide for 26 weeks will preserve insulin-producing beta-cell function, as measured by stimulated C-peptide levels, in adults with LADA. The findings from this study may help determine whether exenatide could be a useful treatment to slow the progression of LADA and delay the need for insulin therapy.

Interventions

Participants in this study will receive MTF-3110 (exenatide immediate-release), a glucagon-like peptide-1 (GLP-1) receptor agonist, administered for the treatment of latent autoimmune diabetes in adults (LADA). Exenatide mimics the action of endogenous GLP-1 and enhances glucose-dependent insulin secretion, suppresses glucagon release, slows gastric emptying, and reduces appetite. The study aims to observe the effects of MTF-3110 on pancreatic beta-cell function. MTF-3110 will be administered at a dose of 10 micrograms twice daily (BID) by subcutaneous injection for a total treatment duration of 26 weeks. Injections will be given within 60 minutes before the morning and evening meals to optimise post-prandial glucose control. The investigational product is supplied as a prefilled, single-patient-use injection pen containing a sterile aqueous solution at a concentration of 250 micrograms per millilitre, delivering 10 micrograms per injection. Subcutaneous injections may be administered into the abdomen, thigh, or upper arm, with rotation of injection sites recommended to minimise local reactions. Participants will self-administer the injections after receiving training from qualified study site staff, such as investigators or study nurses experienced in injectable diabetes therapies. The first dose will be administered under supervision at the baseline visit to confirm correct injection technique and ensure participant understanding of administration procedures. Participants will receive study drug at scheduled clinic visits and will administer the injections individually at home for the remainder of the treatment period. The dosing regimen is fixed at 10 micrograms twice daily for all participants, with no planned dose titration or individual dose adjustments. Adherence to the intervention will be monitored through participant dosing diaries, review of injection technique during study visits, and study drug accountability procedures, including return and counting of used and unused injection pens. The intervention will be delivered in the context of a multicentre clinical trial conducted at participating research centres, with ongoing monitoring of safety, glycaemic control, and beta-cell function throughout the treatment period. Adherence to the investigational product (MTF-3110) is monitored by the return of used and unused injection pens at each visit and checking subject diaries at each visit.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Adults aged 30 to 70 years 2. Diagnosis of diabetes within the past 5 years 3. Positive for at least one islet autoantibody: GAD65, IA-2, or ZnT8 4. Insulin-naïve or insulin exposure for less than 6 months 5. HbA1c between 6.5% and 9.0% 6. BMI between 18 and 35 kg/m² 7. Capable of giving informed consent and complying with protocol requirements

Exclusion criteria

1. A clinical diagnosis consistent with classic type 1 diabetes, including history of diabetic ketoacidosis at onset or requirement for continuous insulin therapy within 6 months of diagnosis. 2. Current or recent use of systemic immunosuppressive therapy within the past 12 months. 3. A history of pancreatitis (acute or chronic), clinically significant gastroparesis, or a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). 4. Renal impairment defined as an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m². 5. Hepatic impairment, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN). 6. Pregnancy, intention to become pregnant during the study period, or breastfeeding. 7. Participation in another investigational drug or device trial within 30 days prior to screening. 8. Known allergy or hypersensitivity to exenatide or other GLP-1 receptor agonists. 9. Prior major gastrointestinal surgery (such as gastric bypass) or any condition that could significantly affect gastric emptying or drug absorption, in the opinion of the investigator. 10. History of proliferative retinopathy or maculopathy requiring acute treatment. 11. History of a major cardiovascular event (myocardial infarction, stroke, or unstable angina) within 180 days of screening. 12. Active malignancy within the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ. 13. Any systemic disease or condition which, in the opinion of the investigator, would place the participant at unacceptable risk or compromise study integrity.

Outcome results