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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Biological: LY2605541
* Biological: Insulin Glargine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2605541<br>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<br> <br> |
| Active Comparator: Insulin Glargine<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp | 
| 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. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |