A Study of LY2605541 and Glargine on Fats in Participants With Type 1 Diabetes

This study is currently recruiting participants.
Verified February 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01771250
First received: January 16, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This study has two parts. Each participant will receive a daily injection of LY2605541 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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Biological: LY2605541
Biological: Insulin Glargine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations [ Time Frame: Day 22 of each treatment period from start of triglyceride metabolism assessment (TMA) procedure (time 0) up to 420 minutes ] [ Designated as safety issue: No ]
  • VLDL-TG Secretion Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ] [ Designated as safety issue: No ]
  • VLDL-TG Oxidation Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ] [ Designated as safety issue: No ]
  • VLDL-TG Clearance Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541
Stable dose of LY2605541 (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
Biological: LY2605541
Daily doses administered SQ.
Active Comparator: Insulin Glargine
Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SQ once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
Biological: Insulin Glargine
Daily doses administered SQ.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771250

Contacts
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
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. Recruiting
Aarhus, Denmark, 8000
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01771250     History of Changes
Other Study ID Numbers: 14871, I2R-MC-BIDN
Study First Received: January 16, 2013
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration
Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014