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

NCT03166124 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16637I8B-MC-ITRR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm

  Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] 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 Outcomes (1)

• 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

Study Arms (4)

Elderly Adults LY900014

EXPERIMENTAL

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

Drug: LY900014

Elderly Adults Insulin Lispro

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Younger Adults LY900014

EXPERIMENTAL

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

Drug: LY900014

Younger Adults Insulin Lispro

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

Elderly Adults LY900014; Younger Adults LY900014

Insulin Lispro DRUG

Administered SC

Also known as: Humalog, LY275585

Elderly Adults Insulin Lispro; Younger Adults Insulin Lispro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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

Location

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

Related Publications (2)

• Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.

  PMID: 34041713 DERIVED

• Linnebjerg H, Zhang Q, LaBell E, Dellva MA, Coutant DE, Hovelmann U, Plum-Morschel L, Herbrand T, Leohr J. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog(R) (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial. Clin Pharmacokinet. 2020 Dec;59(12):1589-1599. doi: 10.1007/s40262-020-00903-0.

  PMID: 32468447 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: May 24, 2017
• Primary Completion: November 18, 2017
• Study Completion: November 18, 2017
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2017-12

Locations

DE (2)