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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04864977
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
9.7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Basal Insulin
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study
Anticipated Study Start Date :
Aug 16, 2021
Anticipated Primary Completion Date :
Jun 6, 2022
Anticipated Study Completion Date :
Jun 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY2963016

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.

Drug: Basal Insulin
Participants administered basal insulin
Other Names:
  • LY2963016

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%) [Week 12]

    2. Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70% [Week 12]

    3. Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM) [Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Medical Center Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04864977
    Other Study ID Numbers:
    • 18095
    • I4L-MC-YCAA
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    T2D
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Insulin

    Study Results

    No Results Posted as of Aug 24, 2021