Status:
WITHDRAWN
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- Contraindication to use of insulin glargine (e.g., allergy)
- Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04864977
Start Date
August 16 2021
End Date
June 6 2022
Last Update
August 24 2021
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118