NCT04864977

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

April 27, 2021

Last Update Submit

August 18, 2021

Conditions

Type 2 DiabetesType 2 Diabetes Treated With Insulin

Keywords

T2D

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)

    Week 12

  • Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%

    Week 12

  • Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)

    Week 12

Study Arms (1)

LY2963016

EXPERIMENTAL

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

Interventions

Basal InsulinDRUG

Participants administered basal insulin

Also known as: LY2963016
LY2963016

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to use of insulin glargine (e.g., allergy)
  • Impaired recognition of hypoglycemia by the participant (as judged by the investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2963016 insulin glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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 DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 29, 2021

Study Start

August 16, 2021

Primary Completion

June 6, 2022

Study Completion

June 6, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.
More information

Locations

US(1)