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

NCT ID: NCT02623452

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• Recruitment Status: WITHDRAWN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

The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

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

Study Groups

Part A:Insulin Lispro Test

Individualized doses of Insulin Lispro test formulation administered by injection under the skin once in each of 3 periods

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Part A:Insulin Lispro Reference

Individualized doses of Insulin Lispro reference formulation administered by injection under the skin once in each of 3 periods

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Part B:Insulin Lispro Test

Individualized doses of Insulin Lispro test formulation administered by injection under the skin with each meal for 14 days

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Part B:Insulin Lispro Reference

Individualized doses of Insulin Lispro reference formulation administered by injection under the skin with each meal for 14 days

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC)

Interventions

Insulin Lispro

Administered subcutaneously (SC)

Intervention Type: DRUG

Eligibility Criteria

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)

• 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-ITCB

Identifier Type: OTHER

Identifier Source: secondary_id

2015-003351-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15627

Identifier Type: -

Identifier Source: org_study_id