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

NCT02623452 | Withdrawn Phase 1

• 3 other identifiers: 15627F3Z-FW-ITCB2015-003351-21
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• (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

  (Part B) PK: AUC of Insulin Lispro

  Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment

Secondary Outcomes (2)

• (Part A) Pharmacodynamics (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

  Time 0 to 5 hours post meal on Day1 and Day14 of study treatment

Study Arms (4)

Part A:Insulin Lispro Test

EXPERIMENTAL

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

Drug: Insulin Lispro

Part A:Insulin Lispro Reference

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Part B:Insulin Lispro Test

EXPERIMENTAL

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

Drug: Insulin Lispro

Part B:Insulin Lispro Reference

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Interventions

Insulin Lispro DRUG

Administered subcutaneously (SC)

Part A:Insulin Lispro Reference; Part A:Insulin Lispro Test; Part B:Insulin Lispro Reference; Part B:Insulin Lispro Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 7, 2015
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 13, 2017

Record last verified: 2017-07