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

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ClinicalTrials.gov Identifier: NCT01769404
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: LY2605541 Biological: Insulin Glargine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY2605541
Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.
Biological: LY2605541
Active Comparator: Insulin Glargine
Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.
Biological: Insulin Glargine



Primary Outcome Measures :
  1. Concentration of Epinephrine [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.


Secondary Outcome Measures :
  1. Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.

  2. Amount of Glucose Required to Maintain BG of 72 mg/dL [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.

  3. Concentration of Cortisol [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  4. Concentration of Glucagon [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  5. Concentration of Growth Hormone [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  6. Concentration of Norepinephrine [ Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp ]
    Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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) less than 9%
  • Otherwise fit and healthy
  • Nonsmoker

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 has poor awareness of hypoglycemia

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): NCT01769404


Locations
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Germany
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.
Neuss, Germany, 41460
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01769404     History of Changes
Other Study ID Numbers: 14870
I2R-MC-BIDM ( Other Identifier: Eli Lilly and Company )
First Posted: January 16, 2013    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs