Clinical trial NCT03555305: A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants
Official title: Relative Bioavailability of LY2963016 to LANTUS® After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus
timeFrame: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus
timeFrame: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose
Secondary outcomes:
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
timeFrame: 30 minutes predose through 24 hours postdose
measure: PD: Maximum Glucose Infusion Rate (Rmax)
timeFrame: 30 minutes predose through 24 hours postdose
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.