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NCT03096392 · ClinicalTrials.gov registry record · Phase 2
Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Diasome Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 5
- Study locations
NCT03096392: Completed Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Diasome Pharmaceuticals.
NCT03096392 is a Phase 2 study of Diabetes Mellitus, Type 1 that has completed, run by Diasome Pharmaceuticals. The registered enrollment target is 46 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03096392, a Phase 2 study of Diabetes Mellitus, Type 1, has completed, sponsored by Diasome Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 5
- Study locations
Study Summary
Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study
Primary Outcome
evaluate continuous glucose monitoring (CGM) profiles during treatment with HDV insulin lispro versus insulin lispro alone, with specific focus on time in range (70-180 mg/dL)
Conditions Studied
Interventions
- DRUG HDV insulin lispro 100 UNT/ML
- DRUG Insulin Lispro 100 UNT/ML
Study Locations (5)
Texas
- Texas Diabetes and Endocrinology - Austin
- Texas Diabetes and Endocrinology - Austin
Colorado
- Barbara Davis Center for Diabetes, University of Colorado - Aurora
Florida
- Baptist Diabetes Associates - Miami
North Carolina
- Lucas Research, Inc. - Morehead City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2018-03-18 |
| Phase | Phase 2 |
What the finished NCT03096392 record still lists
NCT03096392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% 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 insulin lispro 100 UNT/ML is the first listed.
NCT03096392 lists 5 locations in 4 states (Texas, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT03096392 about?
NCT03096392 is a clinical study titled "Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control". Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study
What is the current status of trial NCT03096392?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2017-04-18. Estimated completion is 2018-03-18.
What conditions does trial NCT03096392 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT03096392?
The interventions under investigation include: HDV insulin lispro 100 UNT/ML (DRUG), Insulin Lispro 100 UNT/ML (DRUG).
Who is sponsoring clinical trial NCT03096392?
This trial is sponsored by Diasome Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03096392 being conducted?
This trial has 5 study locations across Colorado, Florida, North Carolina, Texas. 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 NCT03096392's enrollment target sits among peer trials
46 80th of 118 higher than 39 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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