A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

NCT03449433 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 16911I8B-MC-ITSL2017-003459-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm

  PK: Insulin Lispro or Insulin Aspart AUC(0-7h)

  0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose

Secondary Outcomes (1)

• Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

  Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose

Study Arms (5)

LY900014

EXPERIMENTAL

T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.

Drug: LY900014

Insulin Lispro (Humalog®)

ACTIVE COMPARATOR

T1DM participants received a single, individualized, SC dose of insulin lispro.

Drug: Insulin Lispro

Insulin Aspart (NovoRapid®)

ACTIVE COMPARATOR

T1DM participants received a single, individualized, SC dose of insulin aspart.

Drug: Insulin Aspart

Insulin Aspart (Fiasp®)

ACTIVE COMPARATOR

T1DM participants received a single, individualized, SC dose of insulin aspart.

Drug: Insulin Aspart

Healthy Participants

NO INTERVENTION

Healthy participants who received no study drug.

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014

Insulin Lispro DRUG

Administered SC

Also known as: Humalog®, LY275585

Insulin Lispro (Humalog®)

Insulin Aspart DRUG

Administered SC

Also known as: NovoRapid®

Insulin Aspart (NovoRapid®)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
• Have a body mass index (BMI) of 18.5 to 35.0 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro; Insulin Aspart

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: February 23, 2018
• First Posted: February 28, 2018
• Study Start: March 15, 2018
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)