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NCT04864977 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04864977
Other study ID # 18095
Secondary ID I4L-MC-YCAA
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date August 16, 2021
Est. completion date June 6, 2022

Study information
Verified date August 2021
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 6, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Basal Insulin
Participants administered basal insulin

Locations
Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Week 12
Secondary Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%) Week 12
Secondary Percentage of Participants with time in range (TIR) 70-180 mg/dl =70% Week 12
Secondary Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM) Week 12
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