A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus

Sponsors

Lead Sponsor: Eli Lilly and Company

Source Eli Lilly and Company
Brief Summary

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

Overall Status Completed
Start Date May 24, 2017
Completion Date November 18, 2017
Primary Completion Date November 18, 2017
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Secondary Outcome
Measure Time Frame
Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: LY900014

Description: Administered SC

Other Name: Ultra-Rapid Lispro

Intervention Type: Drug

Intervention Name: Insulin Lispro

Description: Administered SC

Eligibility

Criteria:

Inclusion Criteria:

- Are male or female participants with Type 1 Diabetes Mellitus (T1DM)

- Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)

- Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

- Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

- Have a history of renal impairment

- Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives

- Have proliferative retinopathy or maculopathy and/or severe neuropathy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Mainz, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss, Germany
Location Countries

Germany

Verification Date

December 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Elderly Adults LY900014

Type: Experimental

Description: Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.

Label: Elderly Adults Insulin Lispro

Type: Active Comparator

Description: Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.

Label: Younger Adults LY900014

Type: Experimental

Description: Single, SC 15-U dose of LY900014 in the younger adult group.

Label: Younger Adults Insulin Lispro

Type: Active Comparator

Description: Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov