Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04074317 · ClinicalTrials.gov registry record · Phase 2
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
A Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, sponsored by Xeris Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04074317: Completed Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, sponsored by Xeris Pharmaceuticals.
NCT04074317 is a Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 18 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04074317, a Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, has completed, sponsored by Xeris Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
Primary Outcome
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
Conditions Studied
Interventions
- DRUG Regular Insulin
- DRUG PRAM9
- DRUG Regular Insulin + Pramlintide
Study Locations (1)
Texas
- World Wide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2020-04-02 |
| Phase | Phase 2 |
What the finished NCT04074317 record still lists
NCT04074317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 (99% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Regular Insulin is the first listed.
NCT04074317 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04074317 about?
NCT04074317 is a clinical study titled "Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D". This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
What is the current status of trial NCT04074317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-08-22. Estimated completion is 2020-04-02.
What conditions does trial NCT04074317 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Insulin-dependent Diabetes Mellitus.
What interventions are being tested in trial NCT04074317?
The interventions under investigation include: Regular Insulin (DRUG), PRAM9 (DRUG), Regular Insulin + Pramlintide (DRUG).
Who is sponsoring clinical trial NCT04074317?
This trial is sponsored by Xeris Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04074317 being conducted?
This trial has 1 study location across 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 NCT04074317's enrollment target sits among peer trials
18 104th of 118 higher than 14 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Islet Transplantation in Type 1 Diabetic Kidney Allograft
RECRUITING · Phase 2
-
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
RECRUITING · Phase 2
-
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
ACTIVE NOT RECRUITING · Phase 2
-
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
ACTIVE NOT RECRUITING · Phase 2
-
Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)
ACTIVE NOT RECRUITING · Phase 2
-
Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
COMPLETED · Phase 2
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
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI