Healthy SubjectsPhase 1NCT07364669

Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

A Phase 1 study testing Insulex® R (soluble human insulin, biosimilar) and Humulin® R (soluble human insulin, biosimilar) in people with Healthy Subjects, run by Laboratorios Pisa S.A. de C.V. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Insulex® R (soluble human insulin, biosimilar) and Humulin® R (soluble human insulin, biosimilar)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2024to 7 May 2025
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female and male adults, ages ≥ 18 and ≤ 55 years
Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 27.0 kg/m2 and stable body weight by history for ≥ 3 months (defined as change < 5%)
Fasting plasma glucose < 100 mg/dL and HbA1c < 5.7% (based on American Diabetes Association [ADA] criteria; American Diabetes Association, 2023)
Female subjects of childbearing potential (WOCBP) must use highly effective contraception as defined in section 9.1.9 Contraception. For surgically sterile subjects (e.g., those who have undergone bilateral tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), the site will attempt to retrieve medical records that document the sterility; however, the absence of records will not exclude the participant. If medical records cannot be obtained, serum and urine pregnancy tests will be performed. For postmenopausal females (no menses > 12 months), postmenopausal status will be confirmed through testing for FSH levels in the menopausal range (as specified by the responsible laboratory) for amenorrheic subjects.
Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Who cannot join

Pregnant, lactating or intending to become pregnant during the study.
Subjects with confirmed diabetes type 1 or type 2.
Presence of any clinically significant co-morbidities, or physical exam, ECG, or laboratory findings at screening or upon clinic admission that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of the study results.
Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
Supine heart rate > 100 or < 40 beats per minute at screening, based on the average of 3 consecutive measurements.
Supine systolic blood pressure > 140 mm Hg or < 90 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at Screening or upon clinic admission. If blood pressure is outside of the specified ranges, it may be repeated once 20-30 minutes later the same day.

Show all 19Show fewer

Subjects with a prior history of any serious adverse reaction, hypersensitivity to study drugs or drug components.
History of any major surgery within 6 months prior to screening, per Investigator discretion.
History of any active infection, other than mild viral illness within 30 days prior to the first dose of study drug as judged by the Investigator.
History of any active infection, other than mild viral illness within 30 days prior to the first dose of study drug as judged by the Investigator.
History of regular use of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 3 months prior to check-in for the first in-house period. Subjects must refrain from using nicotine-containing products until after the completion of the Follow-Up Visit after the last dose of study drug.
History of drug abuse as judged by the Investigator or a positive urine drug test at Screening or upon clinic admission. 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.
History of or positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody.
Subject is not able to avoid physical activity, avoid alcohol, caffeinated drinks, smoking or medication other than the study medication for 24 hours prior to and throughout the treatment period. (Herbal products and non-routine vitamins are not allowed within 14 days prior to dosing. Routine vitamins are permitted up to 48 hours prior to dosing. Chronic use of acetaminophen is excluded, but occasional use is permitted.) Adequate washout for any concomitant medication that may impact insulin's effect on blood glucose must be ensured and such medications cannot be used throughout the treatment period.
Laboratory or clinical evidence of current infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), i.e., COVID-19, at Screening or upon clinic admission or administration of an approved, authorized, or emergency use approved COVID-19 vaccine within 14 days prior to dosing with study drug.
Any anticipated/planned procedures (e.g., surgery), that interfere with the compliance or the subject's ability to complete the study.
Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
Have previously participated, completed, or withdrawn from this study.
Donation or loss of > 500 mL of whole blood within 8 weeks, platelets within 2 weeks and plasma within 4 weeks of the first dose of study drug. Receipt of blood products within 2 months prior to check-in.

Trial locations and contacts

1 site in 1 country.

United States1 site

Prosciento, Inc
San Diego, California, 92121

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

Read the detailed description

This Phase 1, randomized, double-blind, two-period, two-sequence crossover clinical trial aims to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of Insulex® R compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult subjects. The study was designed in accordance with international regulatory guidelines, including the U.S. Food and Drug Administration (FDA) guidance for demonstrating biosimilarity of insulin products and the European Medicines Agency (EMA) guidelines for the clinical development of biosimilar insulins. Each subject underwent a Screening Visit (Visit 1), two 1-day in-house Treatment Periods (Visit 2 and Visit 3), and a Follow-up Visit (Visit 4) to performed safety procedures. The washout period between Treatment Periods was 7 to 14 days. During each Treatment Period, subjects will receive a single subcutaneous dose of either Insulex® R or Humulin® R under euglycemic glucose clamp conditions. Blood samples will be collected at prespecified intervals to measure serum insulin and C-peptide concentrations. Glucose infusion rates will be monitored continuously to assess PD response. The rigorous assessment of PK and PD profiles under controlled clamp conditions is essential to confirm biosimilarity and ensure therapeutic equivalence. Successful demonstration of bioequivalence will provide a safe, effective, and cost-accessible recombinant human rapid-acting insulin option for patients requiring insulin therapy.

Conditions: Healthy Subjects
Being tested: Insulex® R (soluble human insulin, biosimilar), Humulin® R (soluble human insulin, biosimilar)
Keywords: Recombinant Human Insulin, Bioequivalence, Euglycemic Clamp, Pharmacokinetics (PK), Pharmacodynamics (PD), Short-Acting Insulin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulex® R (soluble human insulin, biosimilar)Drug
Investigational insulin, Insulex® R (soluble human insulin, biosimilar)
Humulin® R (soluble human insulin, biosimilar)Drug
Marketed reference insulin, Humulin® R (soluble human insulin, biosimilar)

Study groups in NCT07364669
Study group	Role	What they receive
Insulex® R	Experimental	Soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight Receives: Drug: Insulex® R (soluble human insulin, biosimilar)
Humulin® R	Active comparator	Soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight Receives: Drug: Humulin® R (soluble human insulin, biosimilar)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCINS_0-12h
Area under the insulin concentration - time curve (AUC) from 0 to 12 hours; primary endpoint to assess PK profile according EMA guideline
Measured: 12 hours
Cmax
Maximum insulin concentration; primary endpoint to assess the PK profile according EMA guideline
Measured: 12 hours
AUCGIR_0-12h
Area under the glucose infusion rate (GIR) time curve from 0 to 12 hours; primary endpoint to assess the PD profile according EMA guideline
Measured: 12 hours
GIRmax
Maximum Glucose Infusion Rate; primary endpoint to assess PD profile according EMA guideline
Measured: 12 hours

Secondary outcomes (25)

AUCINS_0-2h
Area under the partial insulin concentration - time curves (AUC) from 0 to 4 hours; to assess PK profile
Measured: 4 hours
AUCINS_0-6h
Area under the partial insulin concentration - time curves (AUC) from 0 to 6 hours, to assess PK profile
Measured: 6 hours
AUCINS_6-12h
Area under the partial insulin concentration - time curves (AUC) from 6 to 12 hours; to assess PK profile
Measured: 6 hours
AUCINS_0-∞
Area under the serum insulin concentration curve from 0 to infinity (if possible); to assess PK profile
Measured: 12 hours
Tmax
Time to maximum insulin concentration; to assess PK profile
Measured: 12 hours
t50%-INS (early)
Time to half-maximum insulin concentration before maximum insulin concentration (Cmax); to assess PK profile
Measured: 12 hours
t50%-INS (late)
Time to half-maximum insulin concentration after maximum insulin concentration(Cmax); to assess PK profile
Measured: 12 hours
t½
Terminal elimination half - life; to assess PK profile
Measured: 12 hours
λz
Terminal elimination rate constant; to assess PK profile
Measured: 12 hours
AUCGIR_0-2h
Area under glucose infusion rate (GIR) time curve from 0 to 2 hours; to assess PD profile
Measured: 2 hours
AUCGIR_0-6h
Area under glucose infusion rate (GIR) time curve from 0 to 6 hours; to assess PD profile
Measured: 6 hours
AUCGIR_6-12h
Area under glucose infusion rate (GIR) time curve from 6 to 12 hours; to assess PD profile
Measured: 6 hours
tGIR_max
Time to maximum glucose infusion rate (GIR); to assess PD profile
Measured: 12 hours
t50%-GIR (early)
Time to half - maximum glucose infusion rate (GIR) before maximum glucose infusion rate (GIRmax); to assess PD profile
Measured: 12 hours
t50%-GIR (late)
Time to half - maximum glucose infusion rate (GIR) after maximum glucose infusion rate (GIRmax); to assess PD profile
Measured: 12 hours
tGIR_onset
Time to start of glucose infusion rate (GIR) post - dose; to assess PD profile
Measured: 12 hours
Adverse Events
The number and percentage of subjects with TEAEs will be summarized by MedDRA-coded SOCs and PTs. All TEAEs will be assessed for severity and for relation to study drug.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with clinical findings on physical examination from baseline (screening) to follow-up visit.
Physical examination findings considered clinically significant by the PI will be summarized by body system with counts and percentages of subjects for values at treatment visits.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in safety laboratory results (hematology, biochemistry, and urinalysis) for each analite.
Value outside the normal range (as defined by the laboratory) or deemed clinically significant at the Investigator's discretion in safety laboratory results (hematology, serum chemistry, urinalysis) will be recorded and reported as the number of participants with significant changes in safety laboratoriy results.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in ECG parameters.
The following parameters will be recorded from thsubject'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.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Injection site reactions
Evaluated quantitatively using the Grading Scale for Injection Site Reaction (based on the Guidance for Industry-Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, 2007); which assesses pain, tenderness, erythema/redness, and swelling on a four-point scale: Grade 1 - Mild (does not interfere with activity), Grade 2 - Moderate (interferes with activity/discomfort when moving), Grade 3 - Severe (significant discomfort at rest), and Grade 4 - Potentially Life Threatening (Emergency Room visit or hospitalization). For erythema and swelling, the local reaction measured at the single largest diameter should be recorded.
.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in body temperature.
Body temperature in °C. Any clinically significant findings at the investigator's discretion and/or outside the range identified for the vital sign assessment.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in blood pressure.
Given by the measurement of systolic and diastolic blood pressure in mmHg. Any clinically significant findings at the investigator's discretion and/or outside the range identified for the vital sign assessment.
Measured: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in heart rate.
Reading taken in beats per minute (bpm) obtained from the oximeter placed on the tip of the index finger. Any clinically significant findings at the investigator's discretion and/or outside the range identified for the vital sign assessment.
Measured: From screening to follow-up visit (up to 30 days after Visit 1).
Number of participants with significant changes observed from baseline (screening) to follow-up visit in respiratory rate.
Reading taken in breaths per minute (bpm) obtained from the oximeter placed on the tip of the index finger. Any clinically significant findings at the investigator's discretion and/or outside the range identified for the vital sign assessment.
Measured: From screening to follow-up visit (up to 30 days after Visit 1).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 20247 May 2025

First posted23 Jan 2026
Study start24 Oct 2024
Primary completion1 Feb 2025
Study completion7 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies 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: PK/PD euglycemic glucose clamp
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07364669
Sponsor's protocol ID: PROT/01-INSR-24/01
Status last verified: Jan 2026
First submitted: 3 Dec 2025
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA. 2003 May 7;289(17):2254-64. doi: 10.1001/jama.289.17.2254.
PubMed 12734137
DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871
Chance RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.
PubMed 8299470
Vocelka CR, Burdge EC, Kunzelman KS, Thomas R, Verrier ED. An in vitro protocol for evaluation and comparison of membrane oxygenators. J Extra Corpor Technol. 1993;25(4):161-6.
PubMed 10146588
Yamada N, Chung YS, Takatsuka S, Arimoto Y, Sawada T, Dohi T, Sowa M. Increased sialyl Lewis A expression and fucosyltransferase activity with acquisition of a high metastatic capacity in a colon cancer cell line. Br J Cancer. 1997;76(5):582-7. doi: 10.1038/bjc.1997.429.
PubMed 9303355
Colombo TJ, Saward EW, Greenlick MR. The integration of an OEO health program into a prepaid comprehensive group practice plan. Am J Public Health Nations Health. 1969 Apr;59(4):641-50. doi: 10.2105/ajph.59.4.641. No abstract available.
PubMed 5813452
Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes Metab. 2005 Sep;31(4 Pt 2):4S7-4S24. doi: 10.1016/s1262-3636(05)88263-1.
PubMed 16389894

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects
ClinicalTrials.gov ID: NCT07364669
Acronym / sponsor ID: PROT/01-INSR-24/01
Conditions: Healthy Subjects
Keywords: Recombinant Human Insulin, Bioequivalence, Euglycemic Clamp, Pharmacokinetics (PK), Pharmacodynamics (PD), Short-Acting Insulin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Laboratorios Pisa S.A. de C.V.Industry (pharma, biotech, devices)
Collaborators: ProSciento, Inc.
Study start: 24 Oct 2024 (actual)
Primary completion: 1 Feb 2025 (actual)
Study completion: 7 May 2025 (actual)
First posted: 23 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: PK/PD euglycemic glucose clamp

Arm	Type	Receives
Insulex® R	Experimental	Drug: Insulex® R (soluble human insulin, biosimilar)Soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight
Humulin® R	Active comparator	Drug: Humulin® R (soluble human insulin, biosimilar)Soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy female and male adults, ages ≥ 18 and ≤ 55 years
Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 27.0 kg/m2 and stable body weight by history for ≥ 3 months (defined as change < 5%)
Fasting plasma glucose < 100 mg/dL and HbA1c < 5.7% (based on American Diabetes Association [ADA] criteria; American Diabetes Association, 2023)
Female subjects of childbearing potential (WOCBP) must use highly effective contraception as defined in section 9.1.9 Contraception. For surgically sterile subjects (e.g., those who have undergone bilateral tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), the site will attempt to retrieve medical records that document the sterility; however, the absence of records will not exclude the participant. If medical records cannot be obtained, serum and urine pregnancy tests will be performed. For postmenopausal females (no menses > 12 months), postmenopausal status will be confirmed through testing for FSH levels in the menopausal range (as specified by the responsible laboratory) for amenorrheic subjects.
Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Key exclusion criteria (19 listed)

Pregnant, lactating or intending to become pregnant during the study.
Subjects with confirmed diabetes type 1 or type 2.
Presence of any clinically significant co-morbidities, or physical exam, ECG, or laboratory findings at screening or upon clinic admission that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of the study results.
Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
Supine heart rate > 100 or < 40 beats per minute at screening, based on the average of 3 consecutive measurements.

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
Insulex® R (soluble human insulin, biosimilar)Investigational insulin, Insulex® R (soluble human insulin, biosimilar)	Drug	Insulex® R
Humulin® R (soluble human insulin, biosimilar)Marketed reference insulin, Humulin® R (soluble human insulin, biosimilar)	Drug	Humulin® R

Primary outcome

AUCINS_0-12h
Time frame: 12 hours
Area under the insulin concentration - time curve (AUC) from 0 to 12 hours; primary endpoint to assess PK profile according EMA guideline
Cmax
Time frame: 12 hours
Maximum insulin concentration; primary endpoint to assess the PK profile according EMA guideline
AUCGIR_0-12h
Time frame: 12 hours
Area under the glucose infusion rate (GIR) time curve from 0 to 12 hours; primary endpoint to assess the PD profile according EMA guideline
GIRmax
Time frame: 12 hours
Maximum Glucose Infusion Rate; primary endpoint to assess PD profile according EMA guideline

25 secondary outcomes

AUCINS_0-2h
Time frame: 4 hours
AUCINS_0-6h
Time frame: 6 hours
AUCINS_6-12h
Time frame: 6 hours
AUCINS_0-∞
Time frame: 12 hours
Tmax
Time frame: 12 hours
t50%-INS (early)
Time frame: 12 hours
t50%-INS (late)
Time frame: 12 hours
t½
Time frame: 12 hours
λz
Time frame: 12 hours
AUCGIR_0-2h
Time frame: 2 hours
AUCGIR_0-6h
Time frame: 6 hours
AUCGIR_6-12h
Time frame: 6 hours
tGIR_max
Time frame: 12 hours
t50%-GIR (early)
Time frame: 12 hours
t50%-GIR (late)
Time frame: 12 hours
tGIR_onset
Time frame: 12 hours
Adverse Events
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with clinical findings on physical examination from baseline (screening) to follow-up visit.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in safety laboratory results (hematology, biochemistry, and urinalysis) for each analite.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in ECG parameters.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Injection site reactions
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in body temperature.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in blood pressure.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1)
Number of participants with significant changes observed from baseline (screening) to follow-up visit in heart rate.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1).
Number of participants with significant changes observed from baseline (screening) to follow-up visit in respiratory rate.
Time frame: From screening to follow-up visit (up to 30 days after Visit 1).

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 23 Jan 2026.
Background: PubMed 12734137DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA. 2003 May 7;289(17):2254-64. doi: 10.1001/jama.289.17.2254.
Background: PubMed 382871DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
Background: PubMed 8299470Chance RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.
Results publication: PubMed 10146588Vocelka CR, Burdge EC, Kunzelman KS, Thomas R, Verrier ED. An in vitro protocol for evaluation and comparison of membrane oxygenators. J Extra Corpor Technol. 1993;25(4):161-6.
Results publication: PubMed 9303355Yamada N, Chung YS, Takatsuka S, Arimoto Y, Sawada T, Dohi T, Sowa M. Increased sialyl Lewis A expression and fucosyltransferase activity with acquisition of a high metastatic capacity in a colon cancer cell line. Br J Cancer. 1997;76(5):582-7. doi: 10.1038/bjc.1997.429.
Results publication: PubMed 5813452Colombo TJ, Saward EW, Greenlick MR. The integration of an OEO health program into a prepaid comprehensive group practice plan. Am J Public Health Nations Health. 1969 Apr;59(4):641-50. doi: 10.2105/ajph.59.4.641. No abstract available.
Results publication: PubMed 16389894Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes Metab. 2005 Sep;31(4 Pt 2):4S7-4S24. doi: 10.1016/s1262-3636(05)88263-1.
Individual participant dataSharing planned: No

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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?

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 5 inclusion and 19 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 23 Jan 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?

AUCINS_0-12h (time frame: 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364669, which also lists 7 linked publications.

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 23 Jan 2026.