NCT05248841

Brief Summary

This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

January 24, 2022

Last Update Submit

September 13, 2022

Conditions

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Keywords

pharmacokineticpharmacodynamiceuglycemic clamp techniqueinsulin glarginebiosimilarity study

Outcome Measures

Primary Outcomes (4)

  • Area under the concentration-time curve from 0 hours to 24 hours (AUC0-24h) of M1

    The Pharmacokinetics (PK) parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.

    Day 1 and Day 2

  • Maximum observed plasma exogenous insulin glargine concentration (Cmax) of M1

    The PK parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.

    Day 1 and Day 2

  • Area under the Glucose infusion rate (GIR) -time curve (calculated as the exact area under the stepwise constant function) from 0 hours to 24 hours (GIRAUC0-24h)

    The pharmacodynamics (PD) of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.

    Day 1 and Day 2

  • Maximum GIR (GIRmax)

    The PD of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.

    Day 1 and Day 2

Secondary Outcomes (24)

  • Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time (AUC0-t)

    Day 1 and Day 2

  • Area under the concentration-time curve from 0 hours to 6 hours (AUC0-6h)

    Day 1 and Day 2

  • Area under the concentration-time curve from 6 hours to 12 hours (AUC6-12h)

    Day 1 and Day 2

  • Area under the concentration-time curve from 0 hours to 12 hours (AUC0-12h)

    Day 1 and Day 2

  • Area under the concentration-time curve from 12 hours to 18 hours (AUC12-18h)

    Day 1 and Day 2

  • +19 more secondary outcomes

Study Arms (2)

HEC-Glargine Treatment A (Test)

EXPERIMENTAL

Subjects will receive single doses of Test Formulation HEC-Glargine on Day 1 of Treatment periods 1 and 2 followed by at least 7-21 days washout.

Drug: HEC-Glargine

US-Lantus Treatment B (Reference)

ACTIVE COMPARATOR

Subjects will receive single doses of Reference Formulation Lantus on Day 1 followed of Treatment periods 1 and 2 by at least 7-21 days washout.

Drug: US-Lantus

Interventions

HEC-GlargineDRUG

Subjects will receive 0.5 IU/kg of HEC-Glargine subcutaneously as a single morning dose on Day 1.

HEC-Glargine Treatment A (Test)
US-LantusDRUG

Subjects will receive 0.5 IU/kg of Lantus subcutaneously as a single morning dose on Day 1.

Also known as: Insulin glargine
US-Lantus Treatment B (Reference)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant has body weight not less than 60 kg and body mass index between 18.5 and 30.0 kg/m\^2 (both inclusive).
  • Glycohemoglobin (HbA1c) levels are \<6.0%.
  • Normal oral glucose tolerance test conducted within the previous 6 months
  • Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations should be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests
  • Non-smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).

You may not qualify if:

  • 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.
  • Current alcohol use \>21 units of alcohol per week
  • Regular exposure to substances of abuse (other than alcohol) within the past year.
  • Use of any medication, prescribed or over-the-counter or herbal remedies
  • Participation in another study with an experimental drug, where the last administration of the previous study drug was within 12 weeks before administration of study drug in this study.
  • Treatment within the previous 3 months before the first administration of study drug with any drug with a well-defined potential for adversely affecting a major organ or system.
  • A major disease (i.e., a disease that could not be treated at home, but the subject had to be hospitalized or needed general anesthesia usually for a major operation) during the 3 months before commencement of the screening period.
  • Positive test for insulin antibodies.
  • History of bronchial asthma or any other bronchospastic disease, and/or convulsions, and/or porphyria.
  • Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
  • Resting pulse of \>100 beats per minute (bpm) or \<40 bpm during the screening period, either supine or standing.
  • Hypertension diagnosed during screening or current diagnosis of hypertension.
  • Hemoglobin count deviating more than 10% of the lower limit of normal.
  • Clinically relevant abnormalities in the coagulation status.
  • History of bleeding disorders.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FARMOVS Clinical Research Organization

Bloemfontein, Free State, 9301, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 21, 2022

Study Start

March 8, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

ZA(1)