Completed

Pharmacokinetic and Pharmacodynamic Similarity Evaluation Between HEC-Glargine and US-Lantus® in Healthy Adult Males

Study Aim

This study aims to evaluate the pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® in healthy adult males, by comparing the area under the concentration-time curve from 0 hours to 24 hours, maximum observed plasma exogenous insulin glargine concentration, and glucose infusion rate profiles after a single subcutaneous dose.

What is being tested

HEC-Glargine

+ US-Lantus

Drug

Who is being recruted

Autoimmune Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 18 to 55 Years

+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: March 2022

See protocol details

Summary

Principal SponsorLannett Company, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 8, 2022

Actual date on which the first participant was enrolled.

This study aims to compare the safety and effectiveness of two insulin products: HEC-Glargine and US-Lantus®. The study focuses on healthy adult males to understand how these two insulin types behave in the body. The main goal is to demonstrate the similarity between HEC-Glargine and US-Lantus®, which could potentially offer more treatment options for people who need insulin therapy, thereby improving patient care. During the study, participants will receive both HEC-Glargine and US-Lantus®, but at different times. Each insulin type will be administered as a single morning dose in a fasting state. The study will measure how the body responds to each insulin type by assessing the rate at which insulin is absorbed and how effectively it controls blood sugar levels. The study will also monitor any potential side effects. Participants will receive either HEC-Glargine or US-Lantus® first, followed by a wash-out period before receiving the other insulin type, ensuring that the first dose does not interfere with the results of the second dose.

Official TitleA Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

NCT05248841

Principal SponsorLannett Company, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

17 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

FARMOVS Clinical Research Organization

Bloemfontein, South AfricaOpen FARMOVS Clinical Research Organization in Google Maps

CompletedOne Study Center