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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01784211

Diabetes Mellitus, Type 1

COMPLETED PHASE1

A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

NCT01792284

Type 1 Diabetes Mellitus

COMPLETED PHASE3

A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

NCT03056456

Diabetes Mellitus, Type 1

COMPLETED PHASE1

A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

NCT02703324

Diabetes Mellitus, Type 1

COMPLETED PHASE1

A Study of LY900014 in a Medtronic Pump

NCT03760640

Type1 Diabetes Mellitus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY2605541

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type BIOLOGICAL

Insulin Glargine

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.

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY2605541

Intervention Type BIOLOGICAL

Insulin Glargine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No