Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07341373 · ClinicalTrials.gov registry record · Phase 1
A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
A Phase 1 study of Type 1 Diabetes, sponsored by Portal Diabetes.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT07341373: Recruiting Phase 1 study of Type 1 Diabetes, sponsored by Portal Diabetes.
NCT07341373 is a Phase 1 study of Type 1 Diabetes that is actively recruiting participants, run by Portal Diabetes. The registered enrollment target is 25 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07341373, a Phase 1 study of Type 1 Diabetes, is actively recruiting participants, sponsored by Portal Diabetes.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to assess the safety of a new U500 insulin formulation and to determine how rapidly it is absorbed and how long it takes to act when administered intraperitoneally. The trial will be conducted in people with Type 1 Diabetes. The main questions it aims to answer are: Is the drug safe and tolerable when administered intraperitoneally? How fast is it absorbed, and how long does it take to act? Researchers will compare the investigational product (PI-U500) with Humulin R U500 administered intraperitoneally and Lyumjev U100 administered subcutaneously. Participants will undergo a 12-hour clamp procedure in which their blood glucose will be maintained stable via glucose infusion at variable rates after a single intraperitoneal injection of the insulin formulation.
Conditions Studied
Interventions
- DRUG Lyumjev U-100 Insulin
- DRUG Portal Insulin U-500
- DRUG Humulin R U-500
Study Locations (1)
California
- ProSciento, Inc. - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-01 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What NCT07341373 shows while recruiting
NCT07341373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Lyumjev U-100 Insulin is the first listed.
NCT07341373 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07341373 about?
NCT07341373 is a clinical study titled "A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500". The goal of this clinical trial is to assess the safety of a new U500 insulin formulation and to determine how rapidly it is absorbed and how long it takes to act when administered intraperitoneally. The trial will be conducted in people with Type 1 Diabetes. The main questions it aims to answer are...
What is the current status of trial NCT07341373?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2026-01. Estimated completion is 2026-08.
What conditions does trial NCT07341373 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT07341373?
The interventions under investigation include: Lyumjev U-100 Insulin (DRUG), Portal Insulin U-500 (DRUG), Humulin R U-500 (DRUG).
Who is sponsoring clinical trial NCT07341373?
This trial is sponsored by Portal Diabetes, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07341373 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
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 NCT07341373's enrollment target sits among peer trials
25 136th of 198 higher than 59 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
RECRUITING · Phase 1
-
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
RECRUITING · Phase 1
-
Denosumab for Type 1 Diabetes
RECRUITING · Phase 1
-
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
RECRUITING · Phase 1
-
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
RECRUITING · Phase 1
-
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia