West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT03555305
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.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Other names: LY2963016, Basaglar
Administered SC
Other names: Insulin Glargine
Time frame: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.
Time frame: -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.
Time frame: 30 minutes predose through 24 hours postdose
Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Time frame: 30 minutes predose through 24 hours postdose
Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Eli Lilly and Company
Industry
Relative Bioavailability of LY2963016 to LANTUS® After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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