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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T2DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341312
• Other study ID #: 16642
• Secondary ID: I8B-MC-ITRW2017-
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• LY900014
Administered SC
• Insulin Lispro
Administered SC

Locations

Country	Name	City	State
Germany	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BG?AUC) for Each Treatment Arm	GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BG?AUC) 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