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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01771250
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: LY2605541 Biological: Insulin Glargine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus
Study Start Date : October 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. VLDL-TG Secretion Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ]
  3. VLDL-TG Oxidation Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ]
  4. VLDL-TG Clearance Rate [ Time Frame: Day 22 of each treatment period from start of TMA procedure (time 0) up to 420 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771250


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.
Aarhus, Denmark, 8000
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01771250     History of Changes
Other Study ID Numbers: 14871
I2R-MC-BIDN ( Other Identifier: Eli Lilly and Company )
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs