Overview

A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes

Status:
Withdrawn
Trial end date:
2022-06-06
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Insulin
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)