A Phase 4 interventional study of Basal Insulin in Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, sponsored by Eli Lilly and Company. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: LY2963016
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)
Time frame: Week 12
Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)
Time frame: Week 12
Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%
Time frame: Week 12
Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)
Time frame: Week 12
Plan to share: Yes — 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 information: Study protocol, Csr
This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company