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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Biological: Insulin Peglispro; Biological: Insulin Glargine

• Registration Number: NCT01771250
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-03-17
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Peglispro	Insulin Peglispro	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.
Insulin Glargine	Insulin Glargine	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.

Primary Outcome Measures

Name	Time	Method
Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations	Day 22: 240 minutes (min) to 420 min	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	Day 22: 240 min to 420 min	VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Oxidation Rate	Day 22: 240 min to 420 min	VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Clearance Rate	Day 22: 240 min to 420 min	VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

Trial Locations

Locations (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, Denmark