- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769404
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
March 27, 2019 updated by: Eli Lilly and Company
Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Epinephrine
Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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
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The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Cortisol
Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Glucagon
Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Growth Hormone
Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Norepinephrine
Time Frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 14, 2013
First Submitted That Met QC Criteria
January 14, 2013
First Posted (Estimate)
January 16, 2013
Study Record Updates
Last Update Posted (Actual)
June 24, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14870
- I2R-MC-BIDM (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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