A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy

Lilly

Status and phase: Withdrawn; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623465

2015-003353-18 (EudraCT Number)

F3Z-FW-ITCC (Other Identifier)

15628

Details and patient eligibility

About

The study will be conducted in participants with type 2 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female participants with Type 2 Diabetes Mellitus (T2DM)
• Are on stable prandial insulin as a multiple daily injection regimen, plus/minus basal insulin, with or without a stable dose of metformin, for at least 3 months before screening
• Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²)
• 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• Have previously completed or withdrawn from this study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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Part A:Insulin Lispro Test

Experimental group

Description:

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

Treatment:

Drug: Insulin Lispro

Part A:Insulin Lispro Reference

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Lispro

Part B:Insulin Lispro Test

Experimental group

Description:

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

Treatment:

Drug: Insulin Lispro

Part B:Insulin Lispro Reference

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Lispro