A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703350
• Other study ID #: 16068
• Secondary ID: I8B-FW-ITRG2015-
• Status: Completed
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: July 2016

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin

• Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening

• Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study

• Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)

• Have venous access sufficient to allow for blood sampling

• Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

• Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study

• Have previously completed or withdrawn from this study

• Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study

• Had blood loss of more than 500 milliliters (mL) within the last month

• Are treated with a continuous subcutaneous insulin infusion (insulin pump)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY900014
Administered subcutaneously (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

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 From Time Zero to 5 Hours (AUC[0-5h]) (Part A)	PK: Insulin Lispro AUC(0-5h) (Part A)	Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Primary	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)	PK: Insulin Lispro AUC(0-5h) (Part B)	Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Secondary	Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)	PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)	Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes
Secondary	Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)	PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)	Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period

External Links

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