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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769404
• Other study ID #: 14870
• Secondary ID: I2R-MC-BIDM
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• LY2605541

• Insulin Glargine

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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