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Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec

Study comparing HDV-Insulin Lispro and Insulin Lispro in Type 1 Diabetes.

Recruiting
18-79 years
All
Phase 2

This study is testing if a new type of insulin can help people with Type 1 diabetes. **Type 1 diabetes** is when the body doesn't make insulin, a hormone that helps sugar get into cells for energy. The study compares a new insulin called **HDV-Insulin Lispro** to regular insulin, **Insulin Lispro**. HDV stands for **Hepatocyte-Directed Vesicles**, which help deliver insulin to the liver. Participants will undergo blood sugar monitoring using a device on their skin, called **Continuous Glucose Monitoring (CGM)**. The study lasts up to 32 weeks, with different phases to adjust insulin doses and check effects.

**Key Points for Participation:**

  • The study will last up to 32 weeks, including different phases for testing and monitoring.
  • Participants must use the study-provided insulin and device, and meet certain health criteria.
  • Excludes those with allergies to study drugs, pregnant, using certain medications, or with specific health issues.

Participants should be ready for regular check-ups and blood sugar monitoring. The main goal is to see if HDV-Insulin can improve blood sugar control, especially at night, without causing more low blood sugar episodes.

Study details
    Diabetes Mellitus
    Type 1

NCT06238778

Diasome Pharmaceuticlas, Inc.

22 December 2024

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