Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03465878
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 9, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE March 26, 2018
Estimated Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve (AUC) following Each Treatment Arm for Each Study Part [ Time Frame: Baseline through 7 hours post administration of study drug ]
Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve (AUC) following Each Treatment Arm for Each Study Part
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03465878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration versus Time Curve Following each Treatment Arm for Each Study Part [ Time Frame: Pre dose through 5 hours post administration of study drug ]
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration versus Time Curve Following each Treatment Arm for Each Study Part
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Official Title  ICMJE A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
Brief Summary

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Biological: LY900014
    Administered via SC injection
  • Biological: Insulin Lispro
    Administered via SC injection
    Other Names:
    • Humalog
    • LY275585
Study Arms  ICMJE
  • Experimental: LY900014 Subcutaneous
    Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods
    Intervention: Biological: LY900014
  • Active Comparator: Insulin Lispro (Humalog) SC
    Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods
    Intervention: Biological: Insulin Lispro
  • Experimental: LY900014
    Single, SC bolus dose of LY900014 via continuous subcutaneous insulin infusion (CSII) in one of two study periods
    Intervention: Biological: LY900014
  • Active Comparator: Insulin Lispro (Humalog)
    Single, SC bolus dose of insulin lispro (Humalog) via CSII in one of two study periods
    Intervention: Biological: Insulin Lispro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2019
Estimated Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
  • Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria:

  • Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
  • More than one episode of severe hypoglycaemia in the last 6 months
  • Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
  • Have obvious clinical signs or symptoms of liver disease
  • Have a history of renal impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Canada,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465878
Other Study ID Numbers  ICMJE 16695
I8B-MC-ITSA ( Other Identifier: Eli Lilly and Company )
2017-003220-78 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 15, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP