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

• ClinicalTrials.gov Identifier: NCT02623452
• Recruitment Status: Withdrawn
• First Posted: December 7, 2015
• Last Update Posted: July 13, 2017
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: Insulin Lispro	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
• Estimated Study Start Date: January 2018
• Estimated Primary Completion Date: April 2018
• Estimated Study Completion Date: April 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro [ Time Frame: Time 0 to 5 hours post dose for each treatment on Day 1 ]
   (Part A) PK: AUC of Insulin Lispro
2. (Part B) PK: AUC of Insulin Lispro [ Time Frame: Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment ]
   (Part B) PK: AUC of Insulin Lispro

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02623452
• Other Study ID Numbers: 15627; F3Z-FW-ITCB ( Other Identifier: Eli Lilly and Company ); 2015-003351-21 ( EudraCT Number )
• First Posted: December 7, 2015
• Last Update Posted: July 13, 2017
• Last Verified: July 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin Lispro; Hypoglycemic Agents; Physiological Effects of Drugs