- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02623465
A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy
July 12, 2017 updated by: Eli Lilly and Company
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
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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- Have previously completed or withdrawn from this study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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
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
|
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
|
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
|
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
|
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
Time Frame: Time 0 to 5 hours post dose for each treatment on Day 1
|
(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
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 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
Time Frame: Time 0 to 5 hours post meal for each treatment on Day 1
|
(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
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
|
Time 0 to 5 hours post meal on Day1 and Day14 of study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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