Phase 1
Completed N=58
A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants
Healthy
Source: ClinicalTrials.gov NCT03555305 ↗
Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus — 124; 129 picomole per liter (pmol/L)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus |
124; 129 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus |
2170; 2310 | — |
| SECONDARY Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) |
2390; 2680 | — |
| SECONDARY PD: Maximum Glucose Infusion Rate (Rmax) |
2.72; 2.99 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03555305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.