Type 1 Diabetes Mellitus Clinical Trials

Type 1 Diabetes Mellitus Clinical Trials – Overview

Type 1 diabetes mellitus is a less common endocrine and metabolic disorder compared to Type 2 diabetes. It is a multisystem disorder characterized by persistent hyperglycemia, which can manifest in the form of increased thirst, hunger, and frequent urination.

Diabetes also increases susceptibility to infection from bacteria and fungi. Diabetes has been classified into two major and other minor categories, which are:

1. Type 1 Diabetes Mellitus (Insulin Dependent DM)
2. Type 2 diabetes mellitus (non‑insulin‑dependent DM)
3. Other forms include Secondary diabetes, Gestational diabetes, and pre‑diabetes

What is Type 1 Diabetes

Type 1 Diabetes, also known as insulin-dependent diabetes, is less common than Type 2 diabetes. It presents in a slightly different manner from Type 2 Diabetes.

Type 2 diabetes often presents in middle‑aged and older adults and is frequently associated with obesity, while Type 1 diabetes can present at any age, including adults.

This is due to the difference in the underlying pathophysiology of Type 1 and Type 2 Diabetes.

While Type 2 Diabetes occurs due to increased insulin resistance in obese people, Type 1 Diabetes occurs due to a deficiency of insulin. In Type 1 diabetes, autoimmune destruction of pancreatic beta cells causes insulin production to drop to very low or undetectable levels.

Insulin is essential to maintain normal blood glucose levels. Severe insulin deficiency can lead to diabetic ketoacidosis, a life‑threatening condition.

Management of Type 1 Diabetes requires insulin replacement therapy as oral hypoglycemic agents are not effective.

There are many medications for treating diabetes, but only insulin replacement is used in Type 1 diabetes, and it requires careful dosing to avoid potentially fatal hypoglycemia.

Numerous studies continue to evaluate optimal management and disease‑modifying therapies for Type 1 diabetes.

Type 1 Diabetes Mellitus Clinical Trials and Research

1. Vitamin D and residual beta-cell function in type 1 DM

This study is being carried out to evaluate the role of vitamin D supplementation in type 1 diabetes in children who are on standardized insulin treatment.

In this trial, the participants in standardized insulin treatment will be divided into two groups. One group will receive vitamin D (Ergocalciferol), and the other will receive a placebo.

The effects of this will be studied to see if vitamin D users experience a reduction in the long-term complications of type 1 DM.

2. Islet allotransplantation (now zimislecel) in Type 1 DM is in Phase 3; Vertex expects pivotal trial completion in H1 2025 and regulatory filings in 2026

This study aims to achieve insulin independence in patients with type 1 Diabetes.

This study is being carried out to see whether insulin independence can be achieved among those receiving islet transplantation in combination with an immunosuppressive regimen of cyclosporine and sirolimus.

3. Tauroursodeoxycholic acid (TUDCA) in new-onset Type 1 DM (ongoing early‑phase research, no results yet)

A study is currently underway to evaluate whether slowing or preventing beta cell demise can prevent or improve the course of type 1 DM.

This study’s participants will be divided randomly into two groups. One group will receive TUDCA, whereas the other will receive a placebo.

This trial aims to evaluate whether endoplasmic reticulum stress will be reduced by TUDCA and this will, in turn, promote beta-cell survival in new-onset type 1 DM.

4. Safety, tolerability, and potential efficacy of AVT001 (Autologous Dendritic Cell therapy) in a patient with Type 1 DM (no data published as of mid‑2025)

This is a double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of AVT001 and to assess it as a potential treatment for type 1 DM.

Among the participants, one group will be infused with AVT001 and the other will be infused with a placebo.

This trial will then be studied and compared for the safety, tolerability, and potential efficacy of AVT001 in the first group receiving AVT001.

5. Intravenous insulin vs subcutaneous insulin in intrapartum management of Type 1 DM (study ongoing, no results published as of mid‑2025)

This study aims to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduce adverse outcomes associated with type 1 diabetes in pregnancy. Here, investigators are making comparisons between IV insulin and SC insulin therapy.

The participants of this study will be given IV and SC insulin randomly.

The participants will be observed and studied to determine which insulin therapy pathway minimizes risk in the intrapartum management of type 1 DM patients.

See Also

Clinical Trials for Pulmonary Fibrosis Treatment

Tooth Regeneration Clinical Trials

Grants for Diabetics