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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014