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

Lilly

Status and phase: Withdrawn; Phase 4

Conditions: Type 2 Diabetes Treated With Insulin; Type 2 Diabetes

Treatments: Drug: Basal Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04864977

I4L-MC-YCAA (Other Identifier)

18095

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

LY2963016

Experimental group

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.

Treatment:

Drug: Basal Insulin