NCT01769404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

June 24, 2019

Completed
Last Updated

June 24, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

January 14, 2013

Results QC Date

March 17, 2018

Last Update Submit

March 27, 2019

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

LY2605541

EXPERIMENTAL

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

Insulin Glargine

ACTIVE COMPARATOR

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

Interventions

LY2605541BIOLOGICAL
LY2605541
Insulin GlargineBIOLOGICAL
Insulin Glargine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%
  • Otherwise fit and healthy
  • Nonsmoker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

LY2605541Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 24, 2019

Results First Posted

June 24, 2019

Record last verified: 2019-03

Locations

DE(1)