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Trial record 1 of 1 for:    NCT02623465
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A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623465
Recruitment Status : Withdrawn (Change in clinical strategy)
First Posted : December 7, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Lispro Phase 1

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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 2 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

Resource links provided by the National Library of Medicine


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)




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 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


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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623465


Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02623465    
Other Study ID Numbers: 15628
F3Z-FW-ITCC ( Other Identifier: Eli Lilly and Company )
2015-003353-18 ( EudraCT Number )
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs