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 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 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07341373
The ClinicalTrials.gov registry entry for NCT07341373 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The listed sponsor is Portal Diabetes, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.