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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02623465
• Other study ID #: 15628
• Secondary ID: F3Z-FW-ITCC2015-
• Status: Withdrawn
• Phase: Phase 1
• First received: December 3, 2015
• Last updated: July 12, 2017
• Start date: January 2018
• Est. completion date: April 2018

Study information

• Verified date: July 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Lispro
Administered subcutaneously (SC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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
Primary	(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	(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
Secondary	(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