Back to resultsA Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY2605541
Insulin Glargine
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1
Eligibility 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LY2605541
Insulin Glargine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Concentration of Epinephrine
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
Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
Amount of Glucose Required to Maintain BG of 72 mg/dL
The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
Concentration of Cortisol
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.
Concentration of Glucagon
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.
Concentration of Growth Hormone
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.
Concentration of Norepinephrine
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01769404
Brief Title
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2605541
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin Glargine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
LY2605541
Intervention Type
Biological
Intervention Name(s)
Insulin Glargine
Primary Outcome Measure Information:
Title
Concentration of Epinephrine
Description
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.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Secondary Outcome Measure Information:
Title
Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
Description
The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Title
Amount of Glucose Required to Maintain BG of 72 mg/dL
Description
The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Title
Concentration of Cortisol
Description
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.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Title
Concentration of Glucagon
Description
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.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Title
Concentration of Growth Hormone
Description
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.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Title
Concentration of Norepinephrine
Description
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.
Time Frame
30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
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