Healthy ParticipantsPhase 1NCT06627478

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®

A Phase 1 study testing NKF-INS(G), US-Lantus® and EU-Lantus® in people with Healthy Participants, run by Xentria, Inc. at 1 site in South Africa.

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

Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus® Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: NKF-INS(G), US-Lantus® and EU-Lantus®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteSouth Africa
Study dates: 29 Oct 2024to 3 Jul 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.
Healthy male participants
Age between 18 and 50 years, both inclusive
Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
Body weight ≥ 59 kg
Fasting glucose concentration ≤ 5.5 mmol/L at screening

Show all 10Show fewer

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
Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
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 treatment. Male participants must refrain from donating or banking sperm for 90 days after administration of study treatment.
Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Who cannot join

Positive for human insulin antibodies at Screening
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.
Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin, or any specific investigational product safety concern.
History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
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.
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.

Show all 19Show fewer

Clinically significant abnormal ECG at screening.
Glycemia level ≥140 mg/dL 2 hours after the glucose load.
Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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.
Show evidence of an acute infection with fever or infectious disease at the time of enrollment.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening.
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.
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).
Have donated blood or had a blood loss of 500 mL 3 months prior to study enrollment.
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 Clinical Research Unit (CRU).
Employees or close relatives of the Sponsor, contract research organization (CRO), third-party vendors. or affiliates of the above-mentioned parties.
Inadequate venous access.
Vulnerable populations, e.g., persons in detention.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

FARMOVS Clinical Research Organisation
Bloemfontein, 9301

Other trials in South Africa

About this study

Official title: Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(G), US-Lantus®, and EU-Lantus®

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(G), US-Lantus®, and EU-Lantus® using the euglycemic clamp technique in healthy male adult volunteers

Conditions: Healthy Participants
Being tested: NKF-INS(G), US-Lantus®, EU-Lantus®

What participants receive

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

NKF-INS(G)Drug
Single subcutaneous dose of 0.5 IU/kg administered over three periods
US-Lantus®Drug
Single subcutaneous dose of 0.5 IU/kg administered over three periods
EU-Lantus®Drug
Single subcutaneous dose of 0.5 IU/kg administered over three periods

Study groups in NCT06627478
Study group	Role	What they receive
United States (US)-Lantus®	Active comparator	Single subcutaneous dose administered over three treatment periods Receives: Drug: US-Lantus®
European Union (EU)-Lantus®	Active comparator	Single subcutaneous dose administered over three treatment periods Receives: Drug: EU-Lantus®
NKF-INS Glargine (G)	Experimental	Single subcutaneous dose administered over three treatment periods Receives: Drug: NKF-INS(G)

What is being measured

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

Area Under the M1 Concentration-Time Curve From 0 to 12 Hours (AUC0-12h of M1)
Compared the pharmacokinetics (PK) of NKF-INS Glargine(G) to United States (US)-approved and European Union (EU)-authorized Lantus to demonstrate PK similarity for metabolite 21A-Gly-human insulin (M1)
Measured: 0 to 12 hours post-dose

Secondary outcomes (23)

Maximum Capacity (Cmax) of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-6h, AUC6-12h and AUC0-12h of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 12 hours post-dose
Area Under the Concentration-Time Curve AUC12-18h and AUC12-24h of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 12 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC18-24h of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 18 to 24 hours post-dose
Time to Maximum Concentration (Tmax) of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M1
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Maximum Concentration (Cmax) of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-12h and AUC0-24h of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-6hr of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 6 hours post-dose
Area Under the Concentration-Time Curve AUC6-12h of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 6 to 12 hours post-dose
Area Under the Concentration-Time Curve AUC12-18h of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 12 to 18 hours post-dose
Area Under the Concentration-Time Curve AUC18-24h of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 18 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC12-24h of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 12 to 24 hours post-dose
Time to Maximum Concentration (Tmax) of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Insulin Glargine
Evaluated additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine and/or M1.
Measured: 0 to 24 hours post-dose
GIRAUC0-24h, GIRAUC0-end of Clamp up to 24hours, GIRAUC0-6h, GIRAUC0-12h
Compared the pharmacodynamics (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Glucose infusion rate (GIR) was recorded in mg/min throughout the clamp procedure. The area under the GIR-vs-time curve (GIRAUC) was calculated by integrating GIR (mg/min) over time (min). Consistent with the finalized Clinical Study Report and prior trials in this program, the resulting unit is expressed as min*mg/min to explicitly denote the time-integration of the rate variable, rather than simplifying to the mathematically equivalent unit of mg. This notation reflects that GIRAUC represents the integral of an infusion rate over the study duration, consistent with standard reporting conventions for glucose clamp studies
Measured: 0 to 24 hours post-dose
GIRAUC0-∞
Compared the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Glucose infusion rate (GIR) was recorded in mg/min throughout the clamp procedure. The area under the GIR-vs-time curve (GIRAUC) was calculated by integrating GIR (mg/min) over time (min). Consistent with the finalized Clinical Study Report and prior trials in this program, the resulting unit is expressed as min*mg/min to explicitly denote the time-integration of the rate variable, rather than simplifying to the mathematically equivalent unit of mg. This notation reflects that GIRAUC represents the integral of an infusion rate over the study duration, consistent with standard reporting conventions for glucose clamp studies
Measured: 0 to 24 hours post-dose
GIRAUC6-12h
Compared the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Glucose infusion rate (GIR) was recorded in mg/min throughout the clamp procedure. The area under the GIR-vs-time curve (GIRAUC) was calculated by integrating GIR (mg/min) over time (min). Consistent with the finalized Clinical Study Report and prior trials in this program, the resulting unit is expressed as min*mg/min to explicitly denote the time-integration of the rate variable, rather than simplifying to the mathematically equivalent unit of mg. This notation reflects that GIRAUC represents the integral of an infusion rate over the study duration, consistent with standard reporting conventions for glucose clamp studies
Measured: 6 to 12 hours post-dose
GIRAUC12-18h and GIRAUC12-24h
Compared the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Glucose infusion rate (GIR) was recorded in mg/min throughout the clamp procedure. The area under the GIR-vs-time curve (GIRAUC) was calculated by integrating GIR (mg/min) over time (min). Consistent with the finalized Clinical Study Report and prior trials in this program, the resulting unit is expressed as min*mg/min to explicitly denote the time-integration of the rate variable, rather than simplifying to the mathematically equivalent unit of mg. This notation reflects that GIRAUC represents the integral of an infusion rate over the study duration, consistent with standard reporting conventions for glucose clamp studies
Measured: 12 to 24 hours post-dose
GIRAUC18-24h
Compared the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Glucose infusion rate (GIR) was recorded in mg/min throughout the clamp procedure. The area under the GIR-vs-time curve (GIRAUC) was calculated by integrating GIR (mg/min) over time (min). Consistent with the finalized Clinical Study Report and prior trials in this program, the resulting unit is expressed as min*mg/min to explicitly denote the time-integration of the rate variable, rather than simplifying to the mathematically equivalent unit of mg. This notation reflects that GIRAUC represents the integral of an infusion rate over the study duration, consistent with standard reporting conventions for glucose clamp studies
Measured: 18 to 24 hours post-dose
GIRmax
Compared the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Measured: 0 to 24 hours post-dose
Time to GIRmax
Compared the pharmacodynamics (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Measured: 0 to 24 hours post-dose
Total Amount of Glucose Infused During Clamp Procedure (Gtot)
Compared the pharmacodynamics (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
Measured: 0 to 24 hours post-dose

Timeline

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

29 Oct 20243 Jul 2025

First posted4 Oct 2024
Study start29 Oct 2024
Primary completion3 Jul 2025
Study completion3 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06627478
Sponsor's protocol ID: NKF-INS(G)-101
Status last verified: Jul 2026
First submitted: 30 Sep 2024
Last updated: 23 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(G), US-Lantus®, and EU-Lantus®
ClinicalTrials.gov ID: NCT06627478
Acronym / sponsor ID: NKF-INS(G)-101
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Xentria, Inc.Industry (pharma, biotech, devices)
Study start: 29 Oct 2024 (actual)
Primary completion: 3 Jul 2025 (actual)
Study completion: 3 Jul 2025 (actual)
First posted: 4 Oct 2024 (actual)
Results: Posted 23 Oct 2026

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
United States (US)-Lantus®	Active comparator	Drug: US-Lantus®Single subcutaneous dose administered over three treatment periods
European Union (EU)-Lantus®	Active comparator	Drug: EU-Lantus®Single subcutaneous dose administered over three treatment periods
NKF-INS Glargine (G)	Experimental	Drug: NKF-INS(G)Single subcutaneous dose administered over three treatment periods

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.
Healthy male participants
Age between 18 and 50 years, both inclusive
Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
Body weight ≥ 59 kg

Key exclusion criteria (19 listed)

Positive for human insulin antibodies at Screening
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.
Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin, or any specific investigational product safety concern.
History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
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.

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
NKF-INS(G)Single subcutaneous dose of 0.5 IU/kg administered over three periods	Drug	NKF-INS Glargine (G)
US-Lantus®Single subcutaneous dose of 0.5 IU/kg administered over three periods	Drug	United States (US)-Lantus®
EU-Lantus®Single subcutaneous dose of 0.5 IU/kg administered over three periods	Drug	European Union (EU)-Lantus®

Primary outcome

Area Under the M1 Concentration-Time Curve From 0 to 12 Hours (AUC0-12h of M1)
Time frame: 0 to 12 hours post-dose
Compared the pharmacokinetics (PK) of NKF-INS Glargine(G) to United States (US)-approved and European Union (EU)-authorized Lantus to demonstrate PK similarity for metabolite 21A-Gly-human insulin (M1)

23 secondary outcomes

Maximum Capacity (Cmax) of M1
Time frame: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-6h, AUC6-12h and AUC0-12h of M1
Time frame: 0 to 12 hours post-dose
Area Under the Concentration-Time Curve AUC12-18h and AUC12-24h of M1
Time frame: 12 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC18-24h of M1
Time frame: 18 to 24 hours post-dose
Time to Maximum Concentration (Tmax) of M1
Time frame: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M1
Time frame: 0 to 24 hours post-dose
Maximum Concentration (Cmax) of Insulin Glargine
Time frame: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-12h and AUC0-24h of Insulin Glargine
Time frame: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC0-6hr of Insulin Glargine
Time frame: 0 to 6 hours post-dose
Area Under the Concentration-Time Curve AUC6-12h of Insulin Glargine
Time frame: 6 to 12 hours post-dose
Area Under the Concentration-Time Curve AUC12-18h of Insulin Glargine
Time frame: 12 to 18 hours post-dose
Area Under the Concentration-Time Curve AUC18-24h of Insulin Glargine
Time frame: 18 to 24 hours post-dose
Area Under the Concentration-Time Curve AUC12-24h of Insulin Glargine
Time frame: 12 to 24 hours post-dose
Time to Maximum Concentration (Tmax) of Insulin Glargine
Time frame: 0 to 24 hours post-dose
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Insulin Glargine
Time frame: 0 to 24 hours post-dose
GIRAUC0-24h, GIRAUC0-end of Clamp up to 24hours, GIRAUC0-6h, GIRAUC0-12h
Time frame: 0 to 24 hours post-dose
GIRAUC0-∞
Time frame: 0 to 24 hours post-dose
GIRAUC6-12h
Time frame: 6 to 12 hours post-dose
GIRAUC12-18h and GIRAUC12-24h
Time frame: 12 to 24 hours post-dose
GIRAUC18-24h
Time frame: 18 to 24 hours post-dose
GIRmax
Time frame: 0 to 24 hours post-dose
Time to GIRmax
Time frame: 0 to 24 hours post-dose
Total Amount of Glucose Infused During Clamp Procedure (Gtot)
Time frame: 0 to 24 hours post-dose

Results and safety

Results posted to the registry on 23 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NKF-INS(G), EU-Lantus, US-Lantus	19	18
NKF-INS(G), US-Lantus, EU-Lantus	19	18
EU-Lantus, NKF-INS(G), US-Lantus	19	19
EU-Lantus, US-Lantus, NKF-INS(G)	19	19
US-Lantus, NKF-INS(G), EU-Lantus	19	18
US-Lantus, EU-Lantus, NKF-INS(G)	19	19

Primary outcome: Area Under the M1 Concentration-Time Curve From 0 to 12 Hours (AUC0-12h of M1)

Time frame: 0 to 12 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	US-Lantus® n = 111	NKF-INS(G) n = 111	EU-Lantus® n = 111
Value	7.970 (32.479)	7.781 (33.428)	7.564 (33.488)

NKF-INS(G) vs EU-Lantus®: Geometric Mean Ratio]: 102.914 (90% CI 96.886 to 109.318)
US-Lantus® vs NKF-INS(G): Geometric Mean Ratio: 97.723 (90% CI 93.153 to 102.518)

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to EOS visit (2-11 days after last administration of study drug), up to 7 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
United States (US)-Lantus®	0 of 113 (0%)	20 of 113 (17.7%)	0 of 113
NKF-INS Glargine (G)	0 of 114 (0%)	20 of 114 (17.5%)	0 of 114
European Union (EU)-Lantus®	0 of 111 (0%)	31 of 111 (27.9%)	0 of 111

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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?

A Phase 1 study testing NKF-INS(G), US-Lantus® and EU-Lantus® in people with Healthy Participants, run by Xentria, Inc. at 1 site in South Africa.

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 10 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 Oct 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 South Africa. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the M1 Concentration-Time Curve From 0 to 12 Hours (AUC0-12h of M1) (time frame: 0 to 12 hours post-dose). 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 NCT06627478.

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 Oct 2026.