A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)

NCT03341312 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 16642I8B-MC-ITRW2017-001501-33
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)

  PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

  Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose

Secondary Outcomes (1)

• Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm

  -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal

Study Arms (4)

LY900014 Before Meal

EXPERIMENTAL

Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.

Biological: LY900014

LY900014 After Meal

EXPERIMENTAL

Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.

Biological: LY900014

Insulin Lispro (Humalog) Before Meal

ACTIVE COMPARATOR

Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.

Biological: Insulin Lispro

Insulin Lispro (Humalog) After Meal

ACTIVE COMPARATOR

Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.

Biological: Insulin Lispro

Interventions

LY900014 BIOLOGICAL

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014 After Meal; LY900014 Before Meal

Insulin Lispro BIOLOGICAL

Administered SC

Also known as: LY275585, Humalog

Insulin Lispro (Humalog) After Meal; Insulin Lispro (Humalog) Before Meal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
• Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
• Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
• Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening

You may not qualify if:

• Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
• Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
• Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
• Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
• Are treated with a CSII (insulin pump)
• Require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (U/kg/body weight)

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: November 9, 2017
• First Posted: November 14, 2017
• Study Start: November 13, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)