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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04864977
Recruitment Status : Withdrawn (Study was stopped prior to study start date due to business decision.)
First Posted : April 29, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
Type 2 Diabetes Type 2 Diabetes Treated With Insulin Drug: Basal Insulin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : August 16, 2021
Estimated Primary Completion Date : June 6, 2022
Estimated Study Completion Date : June 6, 2022

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Arms and Interventions
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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 Name: LY2963016


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL) [ Time Frame: 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%) [ Time Frame: Week 12 ]
  2. Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70% [ Time Frame: Week 12 ]
  3. Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM) [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864977


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04864977    
Other Study ID Numbers: 18095
I4L-MC-YCAA ( Other Identifier: Eli Lilly and Company )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs