Safety and Dose Ranging Study of HP-211 Botanical Extract for Treatment of Type 2 Diabetes

What this Trial Is About

Researchers are studying type 2 diabetes, a condition where the body cannot properly use insulin to control blood sugar, leading to complications like heart disease, kidney failure, and nerve damage. This research evaluates a botanical extract called HP-211, which has shown promise in lab and animal studies for helping insulin work better to lower blood sugar and insulin levels. The goal is to see if HP-211 can reduce blood glucose and insulin responses in people with type 2 diabetes, especially those with insulin resistance. Participants will be randomly assigned to receive different doses of HP-2110.98 grams, 1.96 grams, or 2.94 grams twice dailyor a placebo, taken as tablets in the morning and evening for 90 days, preferably at least 60 minutes before meals. The study includes a dose-ranging phase to test safety and proof of concept by comparing these doses. Researchers will monitor changes in blood sugar control and insulin levels during the treatment period. Throughout the trial, participants will have blood tests to measure hemoglobin A1c HbA1c, which reflects average blood sugar over time, as well as fasting blood glucose and self-monitored blood glucose profiles. Safety assessments will track adverse events, body weight, and quality of life related to diabetes treatment. The study lasts 12 weeks of treatment plus 4 weeks of withdrawal monitoring, with ongoing evaluations to assess the effects and safety of HP-211 on blood sugar control.

HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes