CClinicalTrials.gg
Sign In
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

Who can participate

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

Inclusion criteria

  1. Signed and dated informed consent 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. Body Mass Index 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, electrocardiogram (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 contraception. 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 investigational 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 excipients, 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 clinically relevant 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 ECG 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 human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening.
  14. Have positive test results for hepatitis B surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or hepatitis C 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.
04

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

05

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

06

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
07

Study locations

1 site
  • Xentria Investigative Site
    Bloemfontein, 9301, South Africa
08

References and documents

Study documents

  • Study protocol · May 6, 2024
  • Statistical analysis plan · Oct 21, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Xentria, Inc.

Start the discussion