Back to resultsA Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Basal Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring T2D
Eligibility Criteria
Inclusion Criteria:
- Adults with type 2 diabetes as diagnosed by endocrinologist
- No insulin over past 3 months
- Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
- No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
- Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.
Exclusion Criteria:
- Contraindication to use of insulin glargine (e.g., allergy)
- Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LY2963016
Arm Description
Participants with type 2 diabetes will be started on insulin glargine and dose will be titrated. Insulin glargine will be delivered via insulin pen each evening subcutaneously (SC). They will also check fasting blood glucose values on a study meter and prior to treating hypoglycemia. Participants will be asked to report the time and dose of their last administration.
Outcomes
Primary Outcome Measures
Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
Percentage of participants with type 2 diabetes who achieve nadir glucose in range (70-125 mg/dl) over 15 consecutive minutes for ≥70% of days (typically 10 days) (last 14 days of active treatment)
Secondary Outcome Measures
Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)
Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%
Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04864977
Brief Title
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
Official Title
Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was stopped prior to study start date due to business decision.
Study Start Date
August 16, 2021 (Anticipated)
Primary Completion Date
June 6, 2022 (Anticipated)
Study Completion Date
June 6, 2022 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)
The study will last about 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Keywords
T2D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2963016
Arm Type
Experimental
Arm Description
Participants with type 2 diabetes will be started on insulin glargine and dose will be titrated. Insulin glargine will be delivered via insulin pen each evening subcutaneously (SC). They will also check fasting blood glucose values on a study meter and prior to treating hypoglycemia. Participants will be asked to report the time and dose of their last administration.
Intervention Type
Drug
Intervention Name(s)
Basal Insulin
Other Intervention Name(s)
LY2963016
Intervention Description
Participants administered basal insulin
Primary Outcome Measure Information:
Title
Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
Description
Percentage of participants with type 2 diabetes who achieve nadir glucose in range (70-125 mg/dl) over 15 consecutive minutes for ≥70% of days (typically 10 days) (last 14 days of active treatment)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)
Time Frame
Week 12
Title
Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%
Time Frame
Week 12
Title
Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with type 2 diabetes as diagnosed by endocrinologist
No insulin over past 3 months
Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.
Exclusion Criteria:
Contraindication to use of insulin glargine (e.g., allergy)
Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
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
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
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 European Union (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
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4QTvp0wrJ1GiK4youuzfmY
Description
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
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A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
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