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

NCT07364669 | Completed Phase 1 FDA Drug

• 1 other identifier: PROT/01-INSR-24/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

Recombinant Human Insulin; Bioequivalence; Euglycemic Clamp; Pharmacokinetics (PK); Pharmacodynamics (PD); Short-Acting Insulin

Outcome Measures

Primary Outcomes (4)

• 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

  12 hours

• Cmax

  Maximum insulin concentration; primary endpoint to assess the PK profile according EMA guideline

  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

  12 hours

• GIRmax

  Maximum Glucose Infusion Rate; primary endpoint to assess PD profile according EMA guideline

  12 hours

Secondary Outcomes (25)

• AUCINS_0-2h

  4 hours

• AUCINS_0-6h

  6 hours

• AUCINS_6-12h

  6 hours

• AUCINS_0-∞

  12 hours

• Tmax

  12 hours

Study Arms (2)

Insulex® R

EXPERIMENTAL

Soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight

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

Drug: Humulin® R (soluble human insulin, biosimilar)

Interventions

Insulex® R (soluble human insulin, biosimilar) DRUG

Investigational insulin, Insulex® R (soluble human insulin, biosimilar)

Insulex® R

Humulin® R (soluble human insulin, biosimilar) DRUG

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

Humulin® R

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Pisa S.A. de C.V.: lead
• ProSciento, Inc.: collaborator

Study Sites (1)

Prosciento, Inc

San Diego, California, 92121, United States

Location

Related Publications (7)

• 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.

  PMID: 12734137 BACKGROUND

• 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.

  PMID: 382871 BACKGROUND

• 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.

  PMID: 8299470 BACKGROUND

• 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.

  PMID: 10146588 RESULT

• 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.

  PMID: 9303355 RESULT

• 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.

  PMID: 5813452 RESULT

• 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.

  PMID: 16389894 RESULT

MeSH Terms

Interventions

Biosimilar Pharmaceuticals

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PK/PD euglycemic glucose clamp

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 23, 2026
• Study Start: October 24, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 7, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)