Type 1 DiabetesPhase 1NCT07341373
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 testing Portal Insulin U-500, Humulin R U-500 and Lyumjev U-100 Insulin in people with Type 1 Diabetes, run by Portal Diabetes, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Portal Insulin U-500, Humulin R U-500 and Lyumjev U-100 Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who meet all the following criteria at Screening will be included in the study:
- Subjects ≥18 to ≤60 years of age at the time of signing the informed consent.
- Subjects diagnosed with T1DM for at least 12 months.
- Subjects who have been using an approved insulin pump or use MDI with basal and bolus insulin (stable use for 3 months).
- Fasting C-peptide concentration of ≤0.3 nmol/L (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL. (If necessary, the subject may consume carbohydrates to raise BG over 90 mg/dL as measured by YSI (glucose analyzer) prior to drawing blood for C-peptide. This may be repeated as needed to ensure C-peptide is assessed when plasma glucose concentration is >90 mg/dL).
- HbA1c concentration of ≤8.5%.
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- Body mass index (BMI) within the range ≥18.5 to ≤30.0 kg/m2.
- Weight ≥ 50 kg.
- Female subjects must be non-pregnant and non-lactating and postmenopausal (no menses >12 months); postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at Screening for all female subjects.
- Male subjects must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject and his partner must be using acceptable methods of contraception.
- Has venous access sufficient to allow for blood sampling.
- Capable of giving signed informed consent and willing to follow study procedures and commitment to the study duration.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participating in the study:
- A subject who has proliferative retinopathy or maculopathy (based on records/documentation of ophthalmologic exam within 18 months of Screening or ophthalmologic exam during Screening), severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- History of ≥2 episodes of severe hypoglycemia (as defined per ADA criteria) or ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to Screening.
- Subject is not able to avoid major dietary changes for the duration of the study.
- Systolic blood pressure >150 mm Hg and/or diastolic blood pressure >90 mm Hg at Screening. Treatment with no more than 2 antihypertensive medications must be with stable doses for at least 3 months prior to Screening.
- Current use of any drugs as listed in the table of prohibited medications.
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- History of any major surgery within 6 months prior to Screening.
- History of any serious allergic adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or abnormal kidney function tests at Screening (GFR <60 mL/min/1.73m2 as estimated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]).
- Triglycerides >500 mg/dL at Screening.
- Clinically significant abnormal hematology or biochemistry screening tests. Subjects may have these labs be redrawn once on a separate day.
- Any history of heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, coronary artery bypass graft surgery, or angioplasty, unstable angina requiring medication, transient ischemic attack, cerebral infarct, or cerebral hemorrhage.
- Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF >450 msec for males, QTcF >470 msec for females) at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results.
- History or presence of malignant neoplasms within the past 5 years prior to the day of Screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
- Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the Investigator.
- Personal or family history of hypercoagulability or thromboembolic disease.
- History of any active infection, other than mild viral illness within 30 days prior to dosing as judged by the Investigator.
- Administration of any vaccinations in the 2 weeks prior to admission to the clinic.
- History of alcohol abuse as judged by the Investigator within approximately 1 year or consuming >2 standard drinks on average per day in men, and >1 standard drinks on average per day in women, and/or positive alcohol breath test at Screening or upon clinic admission. (One drink is defined as 12 fluid ounces of regular beer [5% alcohol], 5 fluid ounces of wine [12% alcohol], or 1.5 fluid ounces of 80 proof [40% alcohol] distilled spirits.)
- History of illicit/recreational drug abuse within approximately 1 year as judged by the Investigator. Frequent use of marijuana or other tetrahydrocannabinol (THC) products within 6 weeks, or clinically under the effect at Screening or upon clinic admission, as per Investigator evaluation or a positive urine drug test at Screening or upon clinic admission.
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); or non- or occasional smoker who is not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period.
- Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C antibody test (anti-HCV), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody at Screening.
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution or metabolism of the drugs or the tolerability/safety measurements.
- Any subject who, per the opinion of the Investigator, will not make a good study subject relative to mental disorder, history of poor treatment adherence, etc.
- Participation in an investigational study within 30 days prior to dosing or within 5 half-lives of the last dose of study drug whichever is longer.
- Donation or loss of >500 mL of blood or blood product within 56 days of Screening.
- Poor venous access as judged by the study team.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Type 1 Diabetes
- Being tested
- Portal Insulin U-500, Humulin R U-500, Lyumjev U-100 Insulin
- Keywords
- Type 1 Diabetes, Insulin, Intraperitoneal, Euglycemic Clamp, Diabetes Mellitus, Human Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal Insulin U-500Drug
Also called PI-U500
Intraperitoneal delivery of a single dose at 0.1 U/kg during an euglycemic clamp
Portal Insulin U-500Drug
Also called PI-U500
Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
Portal Insulin U-500Drug
Also called PI-U500
Intraperitoneal delivery of a single dose at 0.3 U/kg during an euglycemic clamp
Humulin R U-500Drug
Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
Lyumjev U-100 InsulinDrug
Subcutaneous delivery of a single dose at 0.2 U/kg during an euglycemic clamp
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1, Single Ascending Dose | Experimental | Participants will receive PI-U500 intraperitoneally at 0.1 U/kg, then 0.2 U/kg and lastly 0.3 U/kg Receives: Drug: Portal Insulin U-500 |
| Part B, Group 2 | Other | A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.2 U/kg of PI-U500. All administered intraperitoneally. Receives: Drug: Portal Insulin U-500; Drug: Humulin R U-500 |
| Part B, Group 3 | Other | A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.3 U/kg of PI-U500. All administered intraperitoneally. Receives: Drug: Portal Insulin U-500; Drug: Humulin R U-500 |
| Part B, Group 4 | Other | A three-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.3 U/kg of PI-U500, also intraperitoneally. Receives: Drug: Portal Insulin U-500; Drug: Lyumjev U-100 Insulin |
| Part B, Group 5 | Other | A two-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally. Receives: Drug: Portal Insulin U-500; Drug: Lyumjev U-100 Insulin |
| Part B, Group 6 | Other | A three-way crossover where participants will receive 0.2 U/kg of each of the drugs sequentially, but the order will be randomized into three options:
* Option 1: 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally, and finally 0.2 U/kg of PI-U500 intraperitoneally.
* Option 2: 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally , followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously.
* Option 3: 0.2 U/kg of PI-U500 intraperitoneally , followed by 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, and finally 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally. Receives: Drug: Portal Insulin U-500; Drug: Humulin R U-500; Drug: Lyumjev U-100 Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: From enrollment until the follow-up visit, an average of 2 months
Safety: Change from baseline in systolic and diastolic blood pressure
Measured: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in temperature
Measured: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in respiratory rate
Measured: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in heart rate
Measured: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in 12-lead electrocardiogram (ECG) parameters
The following parameters will be recorded from the subject's ECG trace as calculated by the machine algorithm: heart rate, QT interval, PR interval, QRS interval, RR interval, and QTc (corrected) using the Fridericia correction (QTcF = QT ÷ cube root of the R-R interval [where R-R is the duration of the entire cardiac cycle]).
Measured: Pre-dose and after the end of PK-sampling (720 minutes post-dose)
Safety: Incidence and severity of clinical findings on physical examination
Measured: Pre-dose and after the end of PK-sampling (720 minutes post-dose)
Tolerability: Pain assessments per Visual Analogue Scale (VAS)
VAS assessment will target the assessment of abdominal pain. The scale will go from 0 to 10, with 10 being the maximum pain.
Measured: 10 min and 1 hour post-dosing
Tolerability: Change in Interleukin 6 [IL-6] levels
Measured: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Tolerability: Change in tumor necrosis factor [TNF-α] levels
Measured: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Tolerability: Change in high sensitivity C-reactive protein [hsCRP] levels
Measured: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Pharmacokinetic: Area under the insulin concentration-time curve (AUC)
For the duration of the euglycemic clamp
Measured: From the time of dose (time 0) until 12 hours post-dose (AUCIns,0-12h)
Pharmacokinetic: Maximum insulin concentration (Cmax)
Measured: Over 12 hours post-dosing
Pharmacokinetic: Time to maximum insulin concentration (Tmax)
Measured: Over 12 hours post-dosing
Glucodynamic: Area under the glucose infusion rate (GIR) time curve
Measured: From the time of dose (time 0) until 12 hours post-dose (AUCGIR,0-12h)
Glucodynamic: Maximum GIR (GIRmax)
Measured: Over 12 hours post-dosing
Glucodynamic: Time to maximum GIR (TGIRmax)
Measured: Over 12 hours post-dosing
Secondary outcomes (7)
Pharmacokinetic: Area under the partial insulin concentration-time curves (AUC) in time intervals
Measured: From 0 to 15 minutes (AUCIns,0-15 min), from 0-30 minutes (AUCIns,0-30 min) and from 3 hours to end (AUCIns,3h-end)
Pharmacokinetic: Time to half-maximum insulin concentration before Cmax (t50%-INS (early))
Measured: Over 12 hour post-dosing
Pharmacokinetic: Time to half-maximum insulin concentration after Cmax (t50%-INS (late))
Measured: Over 12 hours post-dosing
Pharmacokinetic: Onset of appearance
Defined as time from study drug administration until the first time insulin concentrations were equal to or higher than the lower limit of quantification
Measured: Over 12 hours post-dosing
Glucodynamic: Area under GIR time curve in time intervals
Measured: From 0-30 minutes (AUCGIR,0-30 min), from 0 to 1 hour (AUCGIR,0-1h), from 4 hours to end (AUCGIR,4h-end), from 0 to 6 hours (AUCGIR,0-6h) and from 0 to end (AUCGIR,0-end)
Glucodynamic: Time to half-maximum GIR before GIRmax (t50%-GIR (early))
Measured: Over 12 hours post-dosing
Glucodynamic: Time to half-maximum GIR after GIRmax (t50%-GIR (late))
Measured: Over 12 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Feb 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be conducted in 2 parts. Part A will comprise of a three-way crossover, single ascending doses (SAD) of 3 different dose levels of PI-U500 using a euglycemic clamp. Part B will comprise of a randomized, open-label, two-way and three-way crossover comparative single dose assessment of PI-U500 versus Humulin® R U-500 administered IP versus Lyumjev® U-100 subcutaneously (SC) using a euglycemic clamp.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portal Diabetes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341373
- Sponsor's protocol ID
- PDI-PIU500-C001
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
- ClinicalTrials.gov ID
- NCT07341373
- Acronym / sponsor ID
- PDI-PIU500-C001
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Insulin, Intraperitoneal, Euglycemic Clamp, Diabetes Mellitus, Human Insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Portal Diabetes, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study will be conducted in 2 parts. Part A will comprise of a three-way crossover, single ascending doses (SAD) of 3 different dose levels of PI-U500 using a euglycemic clamp. Part B will comprise of a randomized, open-label, two-way and three-way crossover comparative single dose assessment of PI-U500 versus Humulin® R U-500 administered IP versus Lyumjev® U-100 subcutaneously (SC) using a euglycemic clamp.
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1, Single Ascending Dose | Experimental | Drug: Portal Insulin U-500Participants will receive PI-U500 intraperitoneally at 0.1 U/kg, then 0.2 U/kg and lastly 0.3 U/kg |
| Part B, Group 2 | Other | Drug: Portal Insulin U-500, Drug: Humulin R U-500A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.2 U/kg of PI-U500. All administered intraperitoneally. |
| Part B, Group 3 | Other | Drug: Portal Insulin U-500, Drug: Humulin R U-500A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.3 U/kg of PI-U500. All administered intraperitoneally. |
| Part B, Group 4 | Other | Drug: Portal Insulin U-500, Drug: Lyumjev U-100 InsulinA three-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.3 U/kg of PI-U500, also intraperitoneally. |
| Part B, Group 5 | Other | Drug: Portal Insulin U-500, Drug: Lyumjev U-100 InsulinA two-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally. |
| Part B, Group 6 | Other | Drug: Portal Insulin U-500, Drug: Humulin R U-500, Drug: Lyumjev U-100 InsulinA three-way crossover where participants will receive 0.2 U/kg of each of the drugs sequentially, but the order will be randomized into three options: * Option 1: 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally, and finally 0.2 U/kg of PI-U500 intraperitoneally. * Option 2: 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally , followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously. * Option 3: 0.2 U/kg of PI-U500 intraperitoneally , followed by 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, and finally 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects who meet all the following criteria at Screening will be included in the study:
Key exclusion criteria (27 listed)
- Subjects who meet any of the following criteria will be excluded from participating in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal Insulin U-500Also: PI-U500Intraperitoneal delivery of a single dose at 0.1 U/kg during an euglycemic clamp | Drug | Part A, Group 1, Single Ascending Dose, Part B, Group 2, Part B, Group 3 |
| Portal Insulin U-500Also: PI-U500Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp | Drug | Part A, Group 1, Single Ascending Dose, Part B, Group 2, Part B, Group 4, Part B, Group 5, Part B, Group 6 |
| Portal Insulin U-500Also: PI-U500Intraperitoneal delivery of a single dose at 0.3 U/kg during an euglycemic clamp | Drug | Part A, Group 1, Single Ascending Dose, Part B, Group 3, Part B, Group 4 |
| Humulin R U-500Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp | Drug | Part B, Group 2, Part B, Group 3, Part B, Group 6 |
| Lyumjev U-100 InsulinSubcutaneous delivery of a single dose at 0.2 U/kg during an euglycemic clamp | Drug | Part B, Group 4, Part B, Group 5, Part B, Group 6 |
Primary outcome
Safety: Incidence of adverse events
Time frame: From enrollment until the follow-up visit, an average of 2 months
Safety: Change from baseline in systolic and diastolic blood pressure
Time frame: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in temperature
Time frame: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in respiratory rate
Time frame: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in heart rate
Time frame: Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
Safety: Change from baseline in 12-lead electrocardiogram (ECG) parameters
Time frame: Pre-dose and after the end of PK-sampling (720 minutes post-dose)
The following parameters will be recorded from the subject's ECG trace as calculated by the machine algorithm: heart rate, QT interval, PR interval, QRS interval, RR interval, and QTc (corrected) using the Fridericia correction (QTcF = QT ÷ cube root of the R-R interval [where R-R is the duration of the entire cardiac cycle]).
Safety: Incidence and severity of clinical findings on physical examination
Time frame: Pre-dose and after the end of PK-sampling (720 minutes post-dose)
Tolerability: Pain assessments per Visual Analogue Scale (VAS)
Time frame: 10 min and 1 hour post-dosing
VAS assessment will target the assessment of abdominal pain. The scale will go from 0 to 10, with 10 being the maximum pain.
Tolerability: Change in Interleukin 6 [IL-6] levels
Time frame: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Tolerability: Change in tumor necrosis factor [TNF-α] levels
Time frame: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Tolerability: Change in high sensitivity C-reactive protein [hsCRP] levels
Time frame: Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
Pharmacokinetic: Area under the insulin concentration-time curve (AUC)
Time frame: From the time of dose (time 0) until 12 hours post-dose (AUCIns,0-12h)
For the duration of the euglycemic clamp
Pharmacokinetic: Maximum insulin concentration (Cmax)
Time frame: Over 12 hours post-dosing
Pharmacokinetic: Time to maximum insulin concentration (Tmax)
Time frame: Over 12 hours post-dosing
Glucodynamic: Area under the glucose infusion rate (GIR) time curve
Time frame: From the time of dose (time 0) until 12 hours post-dose (AUCGIR,0-12h)
Glucodynamic: Maximum GIR (GIRmax)
Time frame: Over 12 hours post-dosing
Glucodynamic: Time to maximum GIR (TGIRmax)
Time frame: Over 12 hours post-dosing
7 secondary outcomes
Pharmacokinetic: Area under the partial insulin concentration-time curves (AUC) in time intervals
Time frame: From 0 to 15 minutes (AUCIns,0-15 min), from 0-30 minutes (AUCIns,0-30 min) and from 3 hours to end (AUCIns,3h-end)
Pharmacokinetic: Time to half-maximum insulin concentration before Cmax (t50%-INS (early))
Time frame: Over 12 hour post-dosing
Pharmacokinetic: Time to half-maximum insulin concentration after Cmax (t50%-INS (late))
Time frame: Over 12 hours post-dosing
Pharmacokinetic: Onset of appearance
Time frame: Over 12 hours post-dosing
Glucodynamic: Area under GIR time curve in time intervals
Time frame: From 0-30 minutes (AUCGIR,0-30 min), from 0 to 1 hour (AUCGIR,0-1h), from 4 hours to end (AUCGIR,4h-end), from 0 to 6 hours (AUCGIR,0-6h) and from 0 to end (AUCGIR,0-end)
Glucodynamic: Time to half-maximum GIR before GIRmax (t50%-GIR (early))
Time frame: Over 12 hours post-dosing
Glucodynamic: Time to half-maximum GIR after GIRmax (t50%-GIR (late))
Time frame: Over 12 hours post-dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Portal Insulin U-500, Humulin R U-500 and Lyumjev U-100 Insulin in people with Type 1 Diabetes, run by Portal Diabetes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: From enrollment until the follow-up visit, an average of 2 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.