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

Study Overview
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Brief Summary
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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.

Official Title
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Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study

Conditions
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Type 2 Diabetes, Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Drug: Basal Insulin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2963016<br>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<br>* Participants administered basal insulin<br>* Other names: LY2963016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2D