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NCT06238778

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

A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec
Diasome Pharmaceuticlas, Inc.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Diabetes Mellitus, Type 1
Drug/Device/Intervention
HDV-Lispro
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Diasome Pharmaceuticlas, Inc.
Location
Atlanta,Austin,Round Rock, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Jan 23, 2024
End date
Mar 01, 2026
Enrollment
230 participants
Primary outcome

hypoglycemia events,hypoglycemia percentage of time

Summary

The goal of this study is to see if directing insulin to the liver will improve the low blood
 sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants
 will use continuous glucose monitoring to measure the sugar levels in their blood, and work
 with the doctor to find the best doses. One group of patients will get the liver targeting
 insulin, and the other group will use insulin they normally use for treating Type 1 diabetes.
 The participant will be part of the study for up to 32 weeks.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06238778
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06238778 through Pure Global AI's free database. This Phase 2 trial is sponsored by Diasome Pharmaceuticlas, Inc. and is currently Recruiting. The study focuses on Diabetes Mellitus, Type 1. Target enrollment is 230 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.