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

Phase 4

Withdrawn

• Conditions: Type 2 Diabetes Treated With Insulin; Type 2 Diabetes
• Interventions: Drug: Basal Insulin

• Registration Number: NCT04864977
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Status Verified: 2021-08
• Study Start: 2021-08-16
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-24
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY2963016	Basal Insulin	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)	Week 12	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

Name	Time	Method
Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%	Week 12
Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)	Week 12
Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)	Week 12

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States