Back to resultsA Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY900014
Insulin Degludec
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
- Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
- Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
- Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening
Exclusion Criteria:
- Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
- Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
- Participants must not be taking certain diabetes medications that are not allowed for study participation
Sites / Locations
- Atlanta Diabetes Associates
- Iowa Diabetes and Endocrinology Research Center
- HealthPartners Institute dba International Diabetes Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LY900014 + Insulin Degludec
Arm Description
LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
Outcomes
Primary Outcome Measures
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Secondary Outcome Measures
Insulin to Carbohydrate Ratio (ICR)
ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Prandial:TDD ratio
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04585776
Brief Title
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Official Title
An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY900014 + Insulin Degludec
Arm Type
Experimental
Arm Description
LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
Intervention Type
Drug
Intervention Name(s)
LY900014
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Description
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Time Frame
Day 46
Secondary Outcome Measure Information:
Title
Insulin to Carbohydrate Ratio (ICR)
Description
ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Time Frame
Day 46
Title
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Description
Prandial:TDD ratio
Time Frame
Day 46
Title
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Description
ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Time Frame
Day 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening
Exclusion Criteria:
Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
Participants must not be taking certain diabetes medications that are not allowed for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
HealthPartners Institute dba International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/32HuxMAefU6YDbyMk6SNjR
Description
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes.
Learn more about this trial
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
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