A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus

NCT03407118 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16645I8B-MC-ITRZ
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm

  PK: Insulin Lispro AUC from time zero to 10 hours

  Predose, 5 minutes (min), 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 70 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min, 540 min, and 600 min postdose

Secondary Outcomes (1)

• Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Treatment Arm

  Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose

Study Arms (2)

LY900014

EXPERIMENTAL

Single, 15 units (U)LY900014 administered subcutaneously (SC) in one of two study periods in Japanese Patients With Type 1 Diabetes Mellitus (T1DM).

Drug: LY900014

Insulin Lispro (Humalog)

ACTIVE COMPARATOR

Single, 15 U insulin lispro administered SC in one of two study periods in Japanese Patients With Type 1 Diabetes Mellitus.

Drug: Insulin Lispro

Interventions

LY900014 DRUG

Administered SC.

Also known as: Ultra-Rapid Lispro

LY900014

Insulin Lispro DRUG

Administered SC.

Also known as: LY275585, Humalog

Insulin Lispro (Humalog)

Eligibility Criteria

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

You may qualify if:

• Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening
• Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²)
• Have a glycated hemoglobin \<9.0% at screening

You may not qualify if:

• Have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
• Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening
• Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator
• Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination
• Have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator
• Require daily insulin treatment \>1.5 units per kilogram (U/kg)

Sponsors & Collaborators

• Eli Lilly and Company: lead

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Fukuoka, 812-0025, Japan

Location

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: January 16, 2018
• First Posted: January 23, 2018
• Study Start: February 17, 2018
• Primary Completion: June 23, 2018
• Study Completion: July 12, 2018
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2018-08

Locations

JP (1)