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

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Lispro

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Have previously completed or withdrawn from this study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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A:Insulin Lispro Test; Individualized doses of insulin lispro test formulation administered by injection under the skin once in each of 3 periods	Drug: Insulin Lispro; Administered subcutaneously (SC)
Active Comparator: Part A:Insulin Lispro Reference; Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods	Drug: Insulin Lispro; Administered subcutaneously (SC)
Experimental: Part B:Insulin Lispro Test; Individualized doses of insulin lispro test formulation administered by injection under the skin with each meal for 14 days	Drug: Insulin Lispro; Administered subcutaneously (SC)
Active Comparator: Part B:Insulin Lispro Reference; Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days	Drug: Insulin Lispro; Administered subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro	(Part A) PK: AUC of Insulin Lispro	Time 0 to 5 hours post dose for each treatment on Day 1
(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal	(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal	Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal	(Part A) PD: AUC of Glucose Following a Meal	Time 0 to 5 hours post meal for each treatment on Day 1
(Part B) PD: AUC of Glucose Following a Meal	(Part B) PD: AUC of Glucose Following a Meal	Time 0 to 5 hours post meal on Day1 and Day14 of study treatment

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 15628; F3Z-FW-ITCC (Other Identifier: Eli Lilly and Company); 2015-003353-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No