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CompletedNCT06492226Updated Jan 21, 2026Results posted

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

A Phase 1 interventional study of NKF-INS(A) and EU-NovoRapid® in Healthy Participants, sponsored by Xentria, Inc.. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

Read the detailed description

A single-center, single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® using the euglycemic clamp technique in healthy male adult volunteers

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Xentria, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant
  2. Healthy male participants
  3. Age between 18 and 50 years, both inclusive
  4. between 18.5 and 29.0 kg/m2, both inclusive
  5. Body weight ≥ 50 kg
  6. Fasting plasma glucose concentration ≤ 5.5 mmol/L at screening
  7. Considered generally healthy upon completion of medical history, physical examination, vital signs, (ECG), and analysis of laboratory safety variables, as judged by the Investigator
  8. Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
  9. Participants must agree to use condoms during sexual intercourse. Additionally, female partners of male participants should use highly effective . All contraceptive measures apply from screening until 90 days after study
  10. Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Exclusion criteria

Exclusion Criteria:

  1. Positive for human insulin antibodies at Screening
  2. Are currently enrolled in or have discontinued within 3 months or 5 half-lives (whichever is longer) of any drug or device or are concurrently enrolled in any other type of medical research study and judged not to be scientifically or medically compatible with this study.
  3. Have known allergies to insulin, its , or related drugs or have history of relevant allergic reactions of any origin.
  4. History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
  5. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
  6. Have history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data.
  7. Increased risk of thrombosis, e.g., individuals with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
  8. Clinically significant abnormal at screening.
  9. Glycemia level ≥140.4 mg/dL 2 hours after the glucose load.
  10. Show evidence of significant active neuropsychiatric disease.
  11. Positive urine drug test at screening and/or evidence of current use of known drugs of abuse or have a history of use within the past year.
  12. Show evidence of an acute infection with fever or infectious disease at the time of enrollment.
  13. Show evidence of (HIV) infection and/or positive human HIV antibodies at screening.
  14. Have positive test results for surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or virus (HCV) antibodies at screening.
  15. Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement).
  16. Have donated blood or had a blood loss of 450 mL 3 months prior to study enrollment.
  17. Have an average weekly alcohol intake that exceeds 21 units per week or is unwilling to stop alcohol consumption from 48 hours prior to each dosing until being discharged from the CRU.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    NKF-INS(A)

    Single subcutaneous dose administration over three treatment periods

    Drug: NKF-INS(A)

  • Active comparator
    EU-NovoRapid®

    Single subcutaneous dose administration over three treatment periods

    Drug: EU-NovoRapid®

  • Active comparator
    US-NovoLog®

    Single subcutaneous dose administration over three treatment periods

    Drug: US-NovoLog®

Interventions

  • DrugNKF-INS(A)

    Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

  • DrugEU-NovoRapid®

    Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

  • DrugUS-NovoLog®

    Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

06

What researchers measure

Primary outcomes

  1. Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).

    Compared the Pharmacokinetics (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

    Time frame: Day 1 for 12 Hours

  2. Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)

    Compared the Pharmacokinetic (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

    Time frame: Day 1 for 12 Hours

  3. Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).

    Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

    Time frame: Day 1 for 12 Hours

  4. Maximum GIR (GIRmax) of Glucose

    Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

    Time frame: Day 1 for 12 Hours

Secondary outcomes

  1. PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞

    Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

    Time frame: Day 1 for 12 Hours

  2. Time to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)

    Evaluated Additional Pharmacokinetic (PK) Parameters of NKF-INS(A) Compared to United States (US)-Approved and European (EU)-Authorized Insulin Aspart.

    Time frame: Day 1 for 12 Hours

  3. Time to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)

    Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

    Time frame: Day 1 for 12 Hours

  4. The Terminal Elimination Half-life (t1/2)

    Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

    Time frame: Day 1 for 12 Hours

  5. PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)

    Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

    Time frame: Day 1 for 12 Hours

  6. PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h

    Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

    Time frame: Day 1 for 12 Hours

07

Results

Posted Jan 21, 2026

Participant flow

Participant flow — Overall Study
MilestoneNKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog, EU-NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)
Started999999
Completed898999
Not completed101000
Withdrew: Protocol violation101000

Outcome measures

PrimaryAspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).

Compared the Pharmacokinetics (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · min*ng/ml
Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).
min*ng/mlEU-NovoRapid®US-NovoLog®NKF-INS(A)
Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).894.971 ± 18.426899.163 ± 18.711904.131 ± 17.174
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 101.024 · 95% CI 98.754 to 103.346
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 100.682 · 90% CI 98.567 to 102.843
PrimaryMaximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)

Compared the Pharmacokinetic (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · ng/ml
Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)
ng/mlEU-NovoRapid®US-NovoLog®NKF-INS(A)
Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)1.754 ± 16.3311.754 ± 17.4921.805 ± 15.255
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 104.931 · 95% CI 99.630 to 110.514
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 105.000 · 90% CI 100.827 to 109.345
PrimaryArea Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).

Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · min*mg/min
Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).
min*mg/minEU-NovoRapid®US-NovoLog®NKF-INS(A)
Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).166278.835 ± 25.467167245.347 ± 26.287171020.184 ± 26.779
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 102.851 · 95% CI 96.749 to 109.339
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 102.006 · 90% CI 97.308 to 106.930
PrimaryMaximum GIR (GIRmax) of Glucose

Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · mg/min
Maximum GIR (GIRmax) of Glucose
mg/minEU-NovoRapid®US-NovoLog®NKF-INS(A)
Maximum GIR (GIRmax) of Glucose604.789 ± 26.670619.459 ± 29.184608.934 ± 26.825
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 100.685 · 95% CI 94.956 to 106.760
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 97.980 · 90% CI 92.554 to 103.723
SecondaryPK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞

Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · min*ng/mL
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
min*ng/mLEU-NovoRapid®US-NovoLog®NKF-INS(A)
Area Under the Insulin Aspart Concentration-Time Curve (AUC0 -4h)828.375 ± 19.345834.396 ± 20.308845.061 ± 17.616
Area Under the Insulin Aspart Concentration-Time Curve (AUC0 -6h)891.162 ± 18.308899.163 ± 18.711899.437 ± 17.172
Area Under the Insulin Aspart Concentration-Time Curve AUC0-12h894.971 ± 18.426899.163 ± 18.711904.131 ± 17.174
Area Under the Insulin Aspart Concentration-Time Curve AUC0-∞965.874 ± 19.327988.791 ± 19.146959.327 ± 17.480
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 102.014 · 95% CI 99.090 to 105.025
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 101.419 · 90% CI 99.062 to 103.833
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 100.929 · 95% CI 98.393 to 103.529
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 100.127 · 90% CI 98.080 to 102.217
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 101.024 · 95% CI 98.754 to 103.346
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 100.682 · 90% CI 98.567 to 102.843
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 98.881 · 95% CI 96.400 to 101.426
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 97.023 · 90% CI 94.863 to 99.232
SecondaryTime to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)

Evaluated Additional Pharmacokinetic (PK) Parameters of NKF-INS(A) Compared to United States (US)-Approved and European (EU)-Authorized Insulin Aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · minutes
Time to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)
minutesEU-NovoRapid®US-NovoLog®NKF-INS(A)
Time to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)24.515 ± 22.91926.597 ± 25.39521.980 ± 27.890
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 89.656 · 95% CI 84.557 to 95.064
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 82.086 · 90% CI 76.699 to 87.851
SecondaryTime to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)

Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · minutes
Time to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)
minutesEU-NovoRapid®US-NovoLog®NKF-INS(A)
Time to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)169.891 ± 30.545177.331 ± 29.442161.226 ± 27.896
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 94.900 · 95% CI 89.997 to 100.070
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 90.601 · 90% CI 86.356 to 95.054
SecondaryThe Terminal Elimination Half-life (t1/2)

Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · minutes
The Terminal Elimination Half-life (t1/2)
minutesEU-NovoRapid®US-NovoLog®NKF-INS(A)
The Terminal Elimination Half-life (t1/2)55.742 ± 38.08358.096 ± 47.79553.348 ± 33.361
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 95.232 · 95% CI 88.411 to 102.580
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 91.300 · 90% CI 83.291 to 100.079
SecondaryPK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)

Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · minutes
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)
minutesEU-NovoRapid®US-NovoLog®NKF-INS(A)
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)64.411 ± 37.34469.888 ± 37.38053.904 ± 34.668
Statistical analysis
  • EU-NovoRapid® vs NKF-INS(A) · Geometric mean ratio: 83.687 · 95% CI 76.783 to 91.213
  • US-NovoLog® vs NKF-INS(A) · Geometric mean ratio: 76.497 · 90% CI 69.750 to 83.897
SecondaryPK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h

Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.

Time frame:
Day 1 for 12 Hours
Reported as:
Geometric mean · min*ng/ml
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h
min*ng/mlEU-NovoRapid®NKF-INS(A)
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h36.36 ± NA30.360 ± NA

Adverse events

Collected over Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NKF-INS(A)0/53 (0%)0/53 (0%)8/53 (15.1%)
EU-NovoRapid®0/53 (0%)0/53 (0%)6/53 (11.3%)
US-NovoLog®0/52 (0%)0/52 (0%)4/52 (7.7%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventNKF-INS(A)EU-NovoRapid®US-NovoLog®
HeadacheNervous system disorders3/531/533/52
ThrombophlebitisVascular disorders0/532/530/52
Shoulder girdle painMusculoskeletal and connective tissue disorders0/530/531/52
HaematomaVascular disorders0/531/530/52
Peripheral swellingGeneral disorders1/530/530/52
Infusion site painGeneral disorders1/530/530/52
Musculoskeletal painMusculoskeletal and connective tissue disorders1/530/530/52
AcneSkin and subcutaneous tissue disorders0/531/530/52
PruritusSkin and subcutaneous tissue disorders0/531/530/52
Upper respiratory tract infectionInfections and infestations1/530/530/52

Baseline characteristics

Age, Customized
Age, Customized(years)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Mean36.3 ± 6.230.2 ± 6.334.2 ± 9.832.1 ± 5.730.4 ± 8.435.1 ± 7.833.1 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Female0000000
Male99999954
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Black or African American89697645
Other0020013
White1010226
Not Hispanic or Latino99999954
BMI (kg/m^2)
BMI (kg/m^2)(kg/m^2)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Mean25.1 ± 2.924.7 ± 2.124.3 ± 2.723.9 ± 2.124.7 ± 2.023.7 ± 2.724.4 ± 2.4
Height (cm)
Height (cm)(cm)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Mean171.6 ± 8.9172.2 ± 7.9173.9 ± 7.4172.6 ± 3.9172.4 ± 7.3171.0 ± 9.4172.3 ± 7.4
Weight (kg)
Weight (kg)(kg)NKF-INS(A), EU-NovoRapid, US-NovoLogNKF-INS(A), US-NovoLog-EU, NovoRapidEU-NovoRapid, NKF-INS(A), US-NovoLogEU-NovoRapid, US-NovoLog, NKF-INS(A)US-NovoLog, NKF-INS(A), EU-NovoRapidUS-NovoLog, EU-NovoRapid, NKF-INS(A)Total
Mean73.9 ± 8.873.5 ± 10.673.4 ± 10.271.4 ± 7.173.6 ± 7.769.0 ± 6.972.5 ± 8.5
08

Study locations

1 site
  • Xentria Investigative Site
    Bloemfontein, 9301, South Africa
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06492226
Lead sponsor
Xentria, Inc.
Responsible party
Sponsor
First posted
Jul 9, 2024
Start date
Jul 30, 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Results posted
Jan 21, 2026
Last update
Jan 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Xentria, Inc.

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