Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
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What is type 1 diabetes?
Type 1 diabetes is an autoimmune disease. The immune system destroys the beta cells in the pancreas that make insulin, the hormone that moves sugar from the blood into cells. Without insulin, blood sugar rises to dangerous levels, so people with type 1 must take insulin for life, by injection or pump. It is not caused by diet or weight, and it is different from type 2 diabetes, in which the body still makes insulin but responds to it poorly. It most often appears in childhood or young adulthood but can start at any age. Roughly 2 million Americans have it, compared with nearly 30 million with type 2.
What has changed research is staging. Stage 1 means two or more autoantibodies are present but blood sugar is normal; stage 2 adds abnormal blood sugar without symptoms; stage 3 is the clinical diagnosis. About 75 percent of people at stage 2 progress to stage 3 within four to five years, and nearly all do eventually. That window is where teplizumab (Tzield) works: in its trial, people who received a single 14 day course reached stage 3 after a median of 50 months, versus 25 months on placebo. Screening for autoantibodies, once done only in research, is now offered to relatives of people with type 1 and is spreading to the general population, which is why prevention trials can find participants at all. Genes matter, with the risk higher when a parent or sibling has the disease, but most people diagnosed have no family history, and something in the environment appears to trigger the attack in those at risk.
Types of type 1 diabetes clinical trials
Delaying or preventing the disease. Trials in people at stage 1 or 2 test immune medicines to postpone stage 3: teplizumab in new age groups, baricitinib, a pill approved for other autoimmune conditions, and a platform study comparing teplizumab with another immune drug.
Preserving insulin production after diagnosis. Most people still have 10 to 20 percent of their beta cells at diagnosis. Trials test whether immune treatments started in the first months can protect them, which makes blood sugar easier to control.
Cell replacement. Islet cells grown from stem cells and infused into the liver, currently in Phase 3, and donor or animal islets in protective devices. These aim at insulin independence; see stem cell therapy clinical trials.
New medicines alongside insulin. Studies of GLP-1 medicines such as tirzepatide in adults with type 1, and of drugs that improve how insulin works.
Technology. Automated insulin delivery, sensors, and starting technology early in people at stage 2, plus AI eye screening for children.
Long term and registry studies. Following people treated in earlier trials for years, and registries of people at stage 2.
People with type 1 diabetes are also screened for celiac disease and thyroid conditions, which often occur together.
Who can participate in type 1 diabetes clinical trials?
It depends on the stage. Prevention trials enroll people, often children and teenagers, who have autoantibodies but no diagnosis, usually found through screening because a relative has type 1; many accept ages 1 to 35. Preservation trials enroll people diagnosed within the past few weeks or months. Cell therapy trials enroll adults, typically 18 to 65, with severe low blood sugar episodes or trouble sensing lows, because they take on immune suppressing medicine. Technology and medicine studies enroll adults or children already living with type 1. Most drug trials are placebo controlled, so no one is promised the study medicine. Eligibility always varies by study; our guide explains how eligibility criteria work.
The stages of type 1 diabetes, and why they matter for trials
Stage 1. Two or more autoantibodies, normal blood sugar, no symptoms. Found only by screening. Prevention trials start here.
Stage 2. Autoantibodies plus abnormal blood sugar, still no symptoms. This is where teplizumab is approved and where most delay trials enroll.
Stage 3. Clinical diagnosis with high blood sugar and usually symptoms. Insulin begins. Preservation trials enroll in the first months; medicine, device, and cell therapy trials enroll anyone at this stage.
Study titles say "stage 2," "new onset," or "established" type 1 diabetes, and prevention studies ask for autoantibody results. Knowing your stage, or getting screened if you have a relative with type 1, tells you which studies fit.
Do type 1 diabetes trial participants get paid?
Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
How to enroll in a type 1 diabetes clinical trial
Identify your trial. Use the filters and start with the stage: "stage 2" or "at risk" for prevention studies, "new onset" for preservation, and the medicine, device, or cell therapy name for the rest.
Select your preferred location. Enter your city or state. Cell therapy trials run at a few centers and involve hospital stays; device and medicine studies run widely.
Explore study details. Click "Learn More" for the age range, the required stage or time since diagnosis, and any autoantibody or C peptide tests you will need.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your date of diagnosis or your autoantibody results if you were screened, your current insulin plan and devices, and any other autoimmune conditions.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.