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NCT06238778 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Diasome Pharmaceuticlas.
- Active
- Registry status
- Phase 2
- Development phase
- 227
- Enrollment target
- 20
- Study locations
NCT06238778: Active Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Diasome Pharmaceuticlas.
NCT06238778 is a Phase 2 study of Diabetes Mellitus, Type 1 that is active but no longer recruiting, run by Diasome Pharmaceuticlas. The registered enrollment target is 227 participants, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06238778, a Phase 2 study of Diabetes Mellitus, Type 1, is active but no longer recruiting, sponsored by Diasome Pharmaceuticlas.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 227 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
CGM-measured rates of nocturnal level 2 hypoglycemia events
Conditions Studied
Interventions
- DRUG HDV-Lispro
- DRUG Lispro
Study Locations (20)
Georgia
- Atlanta Diabetes Associates - Atlanta
- East Coast Institute for Research - Canton
- Physicians Research Associates, LLC - Lawrenceville
- Endocrine Research Solutions, Inc. - Roswell
California
- Marvel Clinical Research - Huntington Beach
- Pasadena Clinical Trials - Pasadena
- Diabetes Research Center - Tustin
Florida
- East Coast Institute for Research - Jacksonville
- University of Miami Diabetes Research Institute - Miami
- Metabolic Research Institute - West Palm Beach
North Carolina
- Asheville Clinical Research - Asheville
- UNC EnDO Clinical Research Unit - Chapel Hill
- Physician's East - Greenville
Illinois
- University of Chicago Kovler Diabetes Center - Chicago
- Endeavor Health - Skokie
Colorado
- University of Colorado, Barbara Davis Center - Denver
Indiana
- Indiana Medical Research Institute - Merrillville
New York
- SUNY Upstate Medical University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT06238778 still lists
NCT06238778 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which HDV-Lispro is the first listed.
NCT06238778 names 20 study sites across 10 states, led by Georgia, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06238778 about?
NCT06238778 is a clinical study titled "Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec". 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 f...
What is the current status of trial NCT06238778?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2024-01-23. Estimated completion is 2025-12.
What conditions does trial NCT06238778 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT06238778?
The interventions under investigation include: HDV-Lispro (DRUG), Lispro (DRUG).
Who is sponsoring clinical trial NCT06238778?
This trial is sponsored by Diasome Pharmaceuticlas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06238778 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06238778's enrollment target sits among peer trials
227 30th of 118 higher than 89 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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