Dapagliflozin + Pioglitazone for Type 1 Diabetes

This trial tests how adding two medications, dapagliflozin (an SGLT2 inhibitor) and pioglitazone, to insulin can help manage blood sugar levels in people with type 1 diabetes (T1DM). It aims to determine if this combination can lower blood sugar effectively without causing serious issues like ketoacidosis, a dangerous buildup of acids in the blood. The study compares the effects of pioglitazone to a placebo (a harmless pill that resembles the real treatment) to assess the drug's true impact. People with T1DM who struggle to control their blood sugar with insulin might be suitable candidates, especially if they use multiple insulin injections or an insulin pump daily. As a Phase 4 trial, this research helps to understand how the already FDA-approved treatment benefits more patients.

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking medications other than insulin that affect glucose metabolism, like prednisone.

Research has shown that both dapagliflozin and pioglitazone have been used to treat diabetes, providing information about their safety. Dapagliflozin is approved for type 2 diabetes and has been studied for its ability to control blood sugar without causing major side effects, though it may increase the risk of urinary and genital infections.

Pioglitazone, another medication approved by the FDA for type 2 diabetes, can effectively manage blood sugar levels, according to studies. Some individuals might experience weight gain or swelling. Concerns exist about a higher risk of heart failure and bone fractures with pioglitazone, but for many, the benefits can outweigh these risks.

Researchers are excited about the combination of dapagliflozin and pioglitazone for Type 1 Diabetes because it offers a new approach to managing this condition. Unlike standard treatments that primarily focus on insulin regulation, dapagliflozin works by helping the kidneys remove excess glucose from the bloodstream, which is a unique mechanism for Type 1 Diabetes. Meanwhile, pioglitazone enhances the body's sensitivity to insulin, potentially reducing the amount of insulin needed. This dual-action strategy could lead to better blood sugar control and fewer complications for patients.

Research has shown that dapagliflozin, a type of medication, helps control blood sugar in people with diabetes. Studies have found that it lowers HbA1c levels, a measure of average blood sugar over several months, and can also aid in weight loss—both crucial for managing diabetes. Pioglitazone increases the body's sensitivity to insulin, enhancing its effectiveness. It has improved blood sugar control and lowered the risk of developing type 2 diabetes. In this trial, some participants will receive pioglitazone treatment, while others will receive a placebo. The combination of dapagliflozin and pioglitazone might improve blood sugar control for people with type 1 diabetes without increasing the risk of dangerous acid build-up (ketoacidosis) or low blood sugar (hypoglycemia). This combination therapy aims to provide a more comprehensive approach to managing diabetes by addressing different aspects of the condition.³⁵⁶⁷⁸