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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

LY900014

Insulin Lispro

Insulin Aspart

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

Profil Institut für Stoffwechselforschung

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

LY900014

Insulin Lispro (Humalog®)

Insulin Aspart (NovoRapid®)

Insulin Aspart (Fiasp®)

Healthy Participants

Arm Description

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

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

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

Healthy participants who received no study drug.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

Full Information

NCT ID

NCT03449433

First Posted

February 23, 2018

Last Updated

April 20, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03449433

Brief Title

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

Official Title

A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

March 15, 2018 (Actual)

Primary Completion Date

August 14, 2018 (Actual)

Study Completion Date

August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY900014

Arm Type

Experimental

Arm Description

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

Arm Title

Insulin Lispro (Humalog®)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Insulin Aspart (NovoRapid®)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Insulin Aspart (Fiasp®)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy Participants

Arm Type

No Intervention

Arm Description

Healthy participants who received no study drug.

Intervention Type

Drug

Intervention Name(s)

LY900014

Other Intervention Name(s)

Ultra-Rapid Lispro

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

Humalog®, LY275585

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Aspart

Other Intervention Name(s)

NovoRapid®

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Aspart

Other Intervention Name(s)

Fiasp®

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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 Outcome Measure Information:

Title

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

Description

PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung

City

Neuss

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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