Skip to main content
OpenTrials
Completed

NCT Number: NCT01771250

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Peglispro

Biological

Daily doses administered SC.

Other names: LY2605541

Insulin Glargine

Biological

Daily doses administered SC.

Primary outcomes

  1. Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

    Time frame: 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.

  2. VLDL-TG Secretion Rate

    Time frame: Day 22: 240 min to 420 min

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

  3. VLDL-TG Oxidation Rate

    Time frame: Day 22: 240 min to 420 min

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

  4. VLDL-TG Clearance Rate

    Time frame: Day 22: 240 min to 420 min

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.