Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
T2D
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.
Interventions
DRUGBasal Insulin
Participants administered basal insulin
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL) | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed