A Study of Insulin Peglispro in Healthy Male Japanese Participants
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ClinicalTrials.gov Identifier: NCT01995526 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: Insulin Peglispro | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Insulin Peglispro
Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
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Drug: Insulin Peglispro
Other Name: LY2605541 |
- Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated.
- Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]
- Glucodynamics: Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Predose up to 36 hours post clamp procedure ]
- Glucodynamics: Total Amount of Glucose Infused (Gtot) [ Time Frame: Predose up to 36 hours post clamp procedure. ]

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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]).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995526
Japan | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Fukuoka, Japan, 812-0025 |
Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01995526 |
Other Study ID Numbers: |
14682 I2R-JE-BIDK ( Other Identifier: Eli Lilly and Company ) |
First Posted: | November 26, 2013 Key Record Dates |
Results First Posted: | October 19, 2018 |
Last Update Posted: | October 19, 2018 |
Last Verified: | March 2018 |
Insulin Hypoglycemic Agents Physiological Effects of Drugs |