Clinical Trials for Diabetic Complications

High blood sugar levels caused by diabetes can lead to a number of health complications, including eye problems, kidney problems, and nerve damage. As doctors and researchers continue to learn more about these conditions, they discover new ways to treat them as well. Before treatments can be given to the general public, they must first undergo clinical trials.

Clinical trials are studies that last months to years that investigate a new drug, medical procedure, or medical device. Investigators recruit healthy participants and people with certain health conditions to take part in these studies to determine if a treatment, device, or procedure is safe and effective.

There are currently several clinical trials being conducted to treat and diagnose diabetic complications, including new and previously approved medications and new diagnostic tests. The drugs and tools listed below are just some of the current clinical trials for diabetic complications that are being conducted.

Clinical Trials for Eye Problems from Diabetes

Diabetes can cause several eye conditions to develop, including diabetic retinopathy (DR), glaucoma, and cataracts.

In DR, high blood sugar levels damage the blood vessels in the eye, in turn damaging some of the tissues. Clinical trials currently recruiting participants for diabetic retinopathy include:

• A phase 2 study investigating runcaciguat (which also treats chronic kidney disease) for treating moderately severe to severe non-proliferative DR (NPDR, early DR)²
• A phase 2 trial studying the investigational drug OTT166 in a medicated eye drop for treating moderately severe to severe NPDR or mild proliferative DR (advanced DR)³
• A clinical trial studying the use of artificial intelligence (AI) for analyzing retina images for early signs of DR⁴

Glaucoma is usually caused by increased pressure in the eye, resulting in damage to the optic nerve. A cataract is a cloudy film on the lens in the eye. Cataracts are more likely to occur in people with diabetes because high blood sugar levels can cause the deposits on the eye that result in cataracts. Clinical trials currently recruiting participants for treating open-angle glaucoma (the most common form of glaucoma in people with diabetes) and cataracts include:

• A clinical trial investigating a microstent (small mesh tube to allow fluid to drain) in combination with cataract surgery in people with open-angle glaucoma⁵
• A phase 3 study comparing the investigational drug NCX 470 to latanoprost (Xalatan®) for lowering eye pressure in people with open-angle glaucoma⁶

All clinical trials have inclusion and exclusion criteria that people must meet to participate in a study. Inclusion criteria are requirements you must meet to participate in a particular clinical trial. In clinical trials for diabetic eye complications, inclusion criteria might include:

• Males and females ages 18 to 84 years old
• Open-angle glaucoma in one or both eyes
• No prior eye surgeries

Exclusion criteria prevent you from joining a study if any of them apply to you. Examples of exclusion criteria in some clinical trials for eye complications from diabetes may include:

• Uncontrolled eye pressure (intraocular pressure, IOP)
• Disease in your cornea (the clear outer layer of your eye)
• Severe eye trauma within the past six months of the study

Clinical Trials for Kidney Problems from Diabetes

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High blood sugar levels from diabetes can also damage the tiny blood vessels in the kidney that help filter waste and excess fluid. This can result in diabetic nephropathy (kidney damage) and, if left untreated, can progress to chronic kidney disease (CKD).

Clinical trials investigating treatments for diabetic nephropathy include:

• A phase 2 study investigating the use of fenofibrate (a cholesterol-lowering medication) to help prevent loss of kidney function in people with type 1 diabetes (T1D)⁷
• A phase 1 study investigating the use of computed tomography (CT) with an injection of the drug Tc-99m-tilmanocept to diagnose suspected cases of diabetic nephropathy⁸
• A phase 1 study investigating the use of stem cells from a healthy donor to help treat CKD associated with diabetes⁹

Inclusion criteria for these studies might include:

• Males and females ages 30 to 80 years old
• Living with type 1 diabetes for at least 8 years
• Body mass index (BMI) between 18 to 49.9 kilograms per meter² (kg/m²)

Exclusion criteria for such clinical trials might include:

• Pregnancy or breastfeeding
• Cancer treatment within the past two years
• Hemoglobin A1c (HbA1c) levels at or greater than 11 percent in people with type 2 diabetes

Clinical Trials for Nerve Damage from Diabetes

People living with diabetes can also experience nerve damage from high blood sugar levels. This can affect several nerves around the body, some in your hands and feet (peripheral neuropathy), or others affecting your organs (autonomic neuropathy).

Ongoing clinical trials for these nerve complications from diabetes include:

• A clinical trial comparing the effects of intraneural facilitation (treatment that restores blood supply to nerves) to a sham (“fake”) treatment in people with peripheral neuropathy caused by T2D¹⁰
• An early phase 1 study investigating the needed doses of fish oil supplements with or without the pain reliever salsalate, which may help reduce inflammation and protect nerves in people with peripheral neuropathy¹¹
• A clinical trial investigating the effects of an intense exercise and diet program for treating autonomic neuropathy¹²

Inclusion criteria for such clinical trials could include, for example:

• Males and females ages 30 to 80 years old
• Moderate to severe T2D neuropathy with one or more symptoms of the condition
• HbA1c levels of less than 9.5 percent

Exclusion criteria that might bar you from participating in clinical trials studying interventions for nerve complications from diabetes could include, depending on the study:

• Neuropathy from other causes, including medications, hepatitis C infection, or other neurological conditions
• Having radiation or chemotherapy to treat cancer
• Pregnancy or breastfeeding