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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01769404

Enrollment

Registered

2013-01-16

Start date

2013-02-28

Completion date

2013-12-31

Last updated

2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

BIOLOGICALLY2605541

BIOLOGICALInsulin Glargine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of Epinephrine	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	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

Measure	Time frame	Description
Amount of Glucose Required to Maintain BG of 72 mg/dL	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
Concentration of Cortisol	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	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.
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	The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
Concentration of Growth Hormone	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	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	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	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.
Concentration of Glucagon	30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp	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.

Countries

Germany

Participant flow

Pre-assignment details

As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.

Participants by arm

Arm	Count
All Participants All participants who received at least 1 dose of study drug.	22
Total	22

Withdrawals & dropouts

Period	Reason	FG000
Treatment Period 1	Did not meet eligibility criteria	1
Treatment Period 1	Sponsor decision	1
Treatment Period 1	Withdrawal by Subject	3
Treatment Period 2	Sponsor decision	7

Baseline characteristics

Characteristic	All Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	22 Participants
Region of Enrollment Germany	22 Participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	1 / 9	3 / 7	1 / 13	3 / 13
serious Total, serious adverse events	0 / 9	0 / 7	0 / 13	0 / 13

Outcome results

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.