search
Back to results

A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Peglispro
Insulin Glargine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Peglispro

Insulin Glargine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
VLDL-TG Secretion Rate
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Oxidation Rate
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Clearance Rate
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2013
Last Updated
November 9, 2018
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01771250
Brief Title
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Official Title
Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Peglispro
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin Glargine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Insulin Peglispro
Other Intervention Name(s)
LY2605541
Intervention Description
Daily doses administered SC.
Intervention Type
Biological
Intervention Name(s)
Insulin Glargine
Intervention Description
Daily doses administered SC.
Primary Outcome Measure Information:
Title
Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
Description
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
Time Frame
Day 22: 240 minutes (min) to 420 min
Title
VLDL-TG Secretion Rate
Description
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time Frame
Day 22: 240 min to 420 min
Title
VLDL-TG Oxidation Rate
Description
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time Frame
Day 22: 240 min to 420 min
Title
VLDL-TG Clearance Rate
Description
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time Frame
Day 22: 240 min to 420 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5% Otherwise fit and healthy Non smoker Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

We'll reach out to this number within 24 hrs