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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771250
• Other study ID #: 14871
• Secondary ID: I2R-MC-BIDN
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Insulin Peglispro
Daily doses administered SC.
• Insulin Glargine
Daily doses administered SC.

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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