A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
NCT ID: NCT04864977
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2021-08-16
2022-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will last about 6 months.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study in Patients With Type 2 Diabetes Mellitus
NCT01435616
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
NCT01374178
A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
NCT01790438
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
NCT02955953
A Study for Patients With Type 2 Diabetes
NCT01027871
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Basal Insulin
Participants administered basal insulin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Basal Insulin
Participants administered basal insulin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I4L-MC-YCAA
Identifier Type: OTHER
Identifier Source: secondary_id
18095
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.