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A Study of LY900014 in a Medtronic Pump

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ClinicalTrials.gov Identifier: NCT03760640
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: LY900014 Drug: Insulin Lispro Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of LY900014 in a Medtronic Pump
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY900014
LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G System for 4 weeks.
Drug: LY900014
Administered SC

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G System for 4 weeks.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585




Primary Outcome Measures :
  1. Percentage of Time with Sensor Glucose Values Between 70 and 180 Milligrams per Deciliter (mg/dL) [ Time Frame: Week 2 through Week 4 ]
    Percentage of time with sensor glucose values between 70 and 180 mg/dL


Secondary Outcome Measures :
  1. Mean Sensor Glucose Value [ Time Frame: Week 2 through Week 4 ]
    Mean sensor glucose value

  2. Percentage of Time Spent in Auto Mode [ Time Frame: Week 2 through Week 4 ]
    Percentage of time spent in auto mode

  3. Percentage of Time with Sensor Glucose Values <54 mg/dL [ Time Frame: Week 2 through Week 4 ]
    Percentage of time with sensor glucose values <54 mg/dL

  4. Rate of Severe Hypoglycemic Events [ Time Frame: Week 2 through Week 4 ]
    Rate of severe hypoglycemic events

  5. Total Daily Insulin Dose [ Time Frame: Week 2 through Week 4 ]
    Total daily insulin dose



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
  • Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
  • Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
  • Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
  • Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time

Exclusion Criteria:

  • Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
  • Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
  • Participants must not have a total daily insulin dose >100 units
  • Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
  • Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder

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): NCT03760640


Contacts
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
United States, Georgia
Atlanta Diabetes Associates Not yet recruiting
Atlanta, Georgia, United States, 30318
Principal Investigator: Bruce W Bode         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03760640     History of Changes
Other Study ID Numbers: 16917
I8B-MC-ITSM ( Other Identifier: Eli Lilly and Company )
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs