A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

NCT ID: NCT02623478

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-04-30

Brief Summary

This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Insulin Lispro - Test Formulation

Novel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Insulin Lispro - Reference Formulation

Marketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Interventions

Insulin Lispro

Administered subcutaneously (SC)

Intervention Type: DRUG

Other Intervention Names

Humalog

Eligibility Criteria

Inclusion Criteria

• Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
• Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
• Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are 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 participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems, laboratory test results, blood pressure or ECG readings 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Other Identifiers

F3Z-FW-ITCD

Identifier Type: OTHER

Identifier Source: secondary_id

2015-003353-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15639

Identifier Type: -

Identifier Source: org_study_id