A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants

NCT03555305 | Completed Phase 1 Results

• 2 other identifiers: 13877I4L-MC-ABEF
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in healthy Chinese participants. Blood samples will be taken to compare how the body handles the drugs and how they affect blood sugar levels. Side effects and tolerability will be documented. The study will last at least 18 days, not including screening. Screening is required within 4 weeks prior to the start of the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus

  Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.

  -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

• PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus

  PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC\[0-24\]) of Insulin glargine and Lantus.

  -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Secondary Outcomes (2)

• Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)

  30 minutes predose through 24 hours postdose

• PD: Maximum Glucose Infusion Rate (Rmax)

  30 minutes predose through 24 hours postdose

Study Arms (2)

Insulin Glargine

EXPERIMENTAL

Participants received 0.5 units per kilogram (U/kg) of Insulin Glargine subcutaneously (SC).

Drug: Insulin Glargine

Lantus

ACTIVE COMPARATOR

Participants received 0.5 U/Kg of Lantus subcutaneously.

Drug: Lantus

Interventions

Insulin Glargine DRUG

Administered SC

Also known as: LY2963016, Basaglar

Insulin Glargine

Lantus DRUG

Administered SC

Also known as: Insulin Glargine

Lantus

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are native Chinese men or women. Native Chinese is defined as a participant who has both parents and all 4 grandparents of Chinese origin.
• For females of childbearing potential (defined as not surgically sterilised and between menarche and 1-year postmenopause) only:
• Negative serum pregnancy test at the time of screening.
• Are not lactating.
• Intend not to become pregnant during the study.
• Are sexually inactive or have practiced a reliable method of birth control for at least 6 weeks prior to screening.
• Agree to continue to use a reliable method of birth control (as determined by the investigator) during the study.
• For females not of childbearing potential, must be:
• Surgically sterile, defined as having had a hysterectomy or bilateral oophorectomy or tubal ligation, and/or
• Menopausal, defined as having had no menses for at least 1 year, or a plasma follicular stimulating hormone value of \>40 milli-international units per milliliter (mIU/mL) and no menses for at least 6 months, unless the participant is taking hormone-replacement therapy.
• Having fasting plasma glucose \<110 milligrams per deciliter (mg/dL) (\<6.1 millimoles per liter \[mmol/L\]) and 2-hour glucose level \<140 mg/dL (\<7.8 mmol/L) on the 75 grams (g) oral glucose tolerance test.
• Have a body mass index (BMI) between 18 and 28 kilograms per meter squared (kg/m²), inclusive, at screening.
• Are nonsmokers, have not smoked for at least 6 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study.
• Have normal blood pressure and pulse rate at screening, as determined by the investigator.
• Have an electrocardiogram (ECG), at screening, considered as within normal limits by the investigator.

You may not qualify if:

• Have a history of first-degree relatives known to have diabetes mellitus.
• Have known allergies to insulin glargine or its excipients, or related drugs, or heparin, or have a history of relevant allergic reactions of any origin.
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
• Show evidence of human immunodeficiency virus infection (HIV) and/or positive human HIV antibodies.
• Have positive hepatitis B surface antigen.
• Have donated \>400 mL of blood in the last 6 months or donated \>100 mL within the last 30 days.
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption while resident in the clinical research unit (CRU) (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits).
• Intend to use: prescription medication or over-the-counter medication or Chinese traditional medicine within 14 days before dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods). If this situation arises, an otherwise suitable participant may be included at the discretion of the investigator.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Liu H, Wang F, Ji Y, Ma T, Li H, Linnebjerg H, Chua L, Tham LS, Yu Y. A Euglycemic Glucose Clamp Study to Evaluate the Bioavailability of LY2963016 Relative to Insulin Glargine in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2021 Dec;10(12):1452-1459. doi: 10.1002/cpdd.1014. Epub 2021 Aug 19.

  PMID: 34410042 DERIVED

MeSH Terms

Interventions

Insulin Glargine; LY2963016 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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: September 26, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2019-11-15

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)