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

Phase 1

Withdrawn

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Lispro

• Registration Number: NCT02623478
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-13
• Study Start: 2018-01
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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• Have previously participated or withdrawn from this study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Lispro - Test Formulation	Insulin Lispro	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
Insulin Lispro - Reference Formulation	Insulin Lispro	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro	Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period	PK: AUC of Insulin Lispro

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): AUC of Glucose Following a Meal	Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period	PD: AUC of Glucose Following a Meal