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

NCT ID: NCT03555305

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2019-11-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insulin Glargine

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

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

Administered SC

Lantus

Participants received 0.5 U/Kg of Lantus subcutaneously.

Group Type: ACTIVE_COMPARATOR

Lantus

Intervention Type: DRUG

Administered SC

Interventions

Insulin Glargine

Administered SC

Intervention Type: DRUG

Lantus

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2963016; Basaglar; Insulin Glargine

Eligibility Criteria

Inclusion Criteria

• 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.
• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34410042 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I4L-MC-ABEF

Identifier Type: OTHER

Identifier Source: secondary_id

13877

Identifier Type: -

Identifier Source: org_study_id