A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients

NCT04101383 | Completed

• 1 other identifier: GLARGIN-CL
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)

Conditions

Clamp Study

Keywords

Pharmacokinetics; Pharmacodynamics; Insulin glargine

Outcome Measures

Primary Outcomes (2)

• AUC GIR(0-t)

  Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose

• AUC(0-t)

  Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose

Study Arms (2)

RinGlar®

EXPERIMENTAL

Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg

Drug: RinGlar®

Lantus®

ACTIVE COMPARATOR

Single subcutaneous administration of Lantus® in dose 0.6 Units/kg

Drug: Lantus®

Interventions

RinGlar® DRUG

Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg

Also known as: insulin glargine

RinGlar®

Lantus® DRUG

Single subcutaneous administration of Lantus® in dose 0.6 Units/kg

Also known as: insulin glargine

Lantus®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening.
• Age of 18-65 (both incl.).
• HbA1С ≤ 8,0 %.
• Insulin therapy in stable doses at least 3 months. Total dose of insulin ≤ 1,2 IU/kg per day.
• At least 6 months of Lantus use.
• C-peptide ≤ 0,3 nM/L (or 0,5 ng/mL).
• Body mass index equal to 18.5-32.0 kg/m2.
• Subject must use, with their partner, methods of highly effective contraception throughout the study.
• Subject is able and willing to comply with the requirements of the study protocol.

You may not qualify if:

• Acute inflammatory diseases within 3 weeks before the screening period.
• History or presence of uncontrolled diabetes mellitus for 6 months prior to screening.
• Clinically significant diabetes mellitus complications (proliferative retinopathy, severe diabetic neuropathy, diabetic nephropathy (CKD-EPI \< 60 mL/min/1,73 m2), diabetic foot).
• Clinically significant deviations in basic vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG and lab tests.
• Deep vein thrombosis of lower extremities in a history of life or in a family history.
• Taking medications (excl. insulin and ACE-inhibitors), phytopreparations, biologically active supplements less than 14 days before screening.
• Donor blood donation or another blood loss, less than 3 months before the study.
• Recovery after surgery process.
• Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol, including psychiatric disorders.
• History of significant drugs abuse conditions for 3 years prior to screening.
• Positive testing for drugs.
• Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
• Positive testing for alcohol.
• Nicotine dependence (use of tobacco less than 6 months before the start of screening).
• Positive test results for hepatitis C or hepatitis B, HIV, syphilis.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (2)

Endocrinology Research Centre

Moscow, 117036, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Interventions

Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was blinded for Sponsor, investigators and analytical laboratory
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 24, 2019
• Study Start: October 16, 2017
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)