NCT01771250

Brief Summary

This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 11, 2019

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

January 16, 2013

Results QC Date

March 17, 2018

Last Update Submit

November 9, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (4)

  • Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

    VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.

    Day 22: 240 minutes (min) to 420 min

  • VLDL-TG Secretion Rate

    VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

    Day 22: 240 min to 420 min

  • VLDL-TG Oxidation Rate

    VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

    Day 22: 240 min to 420 min

  • VLDL-TG Clearance Rate

    VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

    Day 22: 240 min to 420 min

Study Arms (2)

Insulin Peglispro

EXPERIMENTAL

Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram \[U/kg\]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.

Biological: Insulin Peglispro

Insulin Glargine

ACTIVE COMPARATOR

Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.

Biological: Insulin Glargine

Interventions

Insulin PeglisproBIOLOGICAL

Daily doses administered SC.

Also known as: LY2605541
Insulin Peglispro
Insulin GlargineBIOLOGICAL

Daily doses administered SC.

Insulin Glargine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
  • Otherwise fit and healthy
  • Non smoker

You may not qualify if:

  • Taking medication or supplements other than insulin to control diabetes.
  • Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
  • Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

basal insulin peglisproLY2605541Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 11, 2019

Results First Posted

March 11, 2019

Record last verified: 2018-11

Locations

DK(1)