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

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

Sponsors

Lead Sponsor: Eli Lilly and Company

Source 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.

Overall Status Completed
Start Date February 2013
Completion Date December 2013
Primary Completion Date December 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Concentration of Epinephrine 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Secondary Outcome
Measure Time Frame
Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Amount of Glucose Required to Maintain BG of 72 mg/dL 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Cortisol 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Glucagon 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Growth Hormone 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Norepinephrine 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Enrollment 25
Condition
Intervention

Intervention Type: Biological

Intervention Name: LY2605541

Arm Group Label: LY2605541

Intervention Type: Biological

Intervention Name: Insulin Glargine

Arm Group Label: Insulin Glargine

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Location
Facility: 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.
Location Countries

Germany

Verification Date

March 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: LY2605541

Type: Experimental

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.

Label: Insulin Glargine

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov