Phase 1
Completed N=11
A Study of Insulin Peglispro in Healthy Male Japanese Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01995526 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro — 3720 picomoles/liter (pmol/L)
Summary
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro |
3720 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro |
280000 | — |
| PRIMARY Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro |
39.00 | — |
| PRIMARY Glucodynamics: Maximum Glucose Infusion Rate (Rmax) |
1.75 | — |
| PRIMARY Glucodynamics: Total Amount of Glucose Infused (Gtot) |
2180 | — |
Eligibility Criteria
Inclusion Criteria
- Participants are overtly healthy male Japanese.
- Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive.
Exclusion Criteria
- Participants have known allergies to insulin peglispro or related compounds.
- Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).
Data sourced from ClinicalTrials.gov (NCT01995526). 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.