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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 two types of insulin for adults with Type 1 Diabetes.

Recruiting
18-79 years
All
Phase 2

Study Purpose: This study looks at a new way to give insulin for adults with Type 1 diabetes. We want to see if sending insulin straight to the liver helps reduce low blood sugar (also called hypoglycemia) when compared to regular insulin shots.

How It Works: Participants will be split into two groups. One group will get liver-targeting insulin (HDV-Insulin Lispro), and the other group will use their regular insulin (Insulin Lispro). Both groups will also use Insulin Degludec, a type of long-acting insulin. The study lasts up to 32 weeks, which includes several periods for screening and adjusting insulin doses.

Eligibility:

  • Must be between 18 and 80 years old with Type 1 diabetes.
  • Use of certain insulins and a Continuous Glucose Monitor (CGM) is required.
  • Cannot be pregnant or using certain medications.

Things to Consider:

  • The study lasts about 32 weeks with several visit requirements.
  • You will need to use specific insulin and a CGM device provided by the study.
  • There may be risks, such as low blood sugar or reactions to insulin.
Study details
    Diabetes Mellitus
    Type 1

NCT06238778

Diasome Pharmaceuticlas, Inc.

22 December 2024

Step 1 Get in touch with the nearest study center
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