A Study of Insulin Peglispro in Healthy Male Japanese Participants

NCT01995526 | Completed Phase 1 Results

• 2 other identifiers: 14682I2R-JE-BIDK
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro

  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

  AUC from time zero to infinity (AUC\[0-∞\]) of insulin peglispro was evaluated.

  Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

• Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro

  Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

• Glucodynamics: Maximum Glucose Infusion Rate (Rmax)

  Predose up to 36 hours post clamp procedure

• Glucodynamics: Total Amount of Glucose Infused (Gtot)

  Predose up to 36 hours post clamp procedure.

Study Arms (1)

Insulin Peglispro

EXPERIMENTAL

Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.

Drug: Insulin Peglispro

Interventions

Insulin Peglispro DRUG

Also known as: LY2605541

Insulin Peglispro

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[mmol/L\]).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 812-0025, Japan

Location

MeSH Terms

Interventions

basal insulin peglispro; LY2605541

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-03

Locations

JP (1)