A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
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
2 other identifiers
interventional
31
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedResults Posted
Study results publicly available
June 3, 2022
CompletedJune 3, 2022
May 1, 2022
7 months
October 8, 2020
May 6, 2022
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 46
Secondary Outcomes (3)
Insulin to Carbohydrate Ratio (ICR)
Day 46
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Day 46
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Day 46
Study Arms (1)
LY900014 + Insulin Degludec
EXPERIMENTALLY900014 (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Related Publications (1)
Bergenstal RM, Bode BW, Bhargava A, Wang Q, Knights AW, Chang AM. Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. Diabetes Ther. 2023 Nov;14(11):1933-1945. doi: 10.1007/s13300-023-01476-4. Epub 2023 Sep 23.
PMID: 37740871DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2020
First Posted
October 14, 2020
Study Start
October 30, 2020
Primary Completion
May 27, 2021
Study Completion
May 27, 2021
Last Updated
June 3, 2022
Results First Posted
June 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.