Type 2 Diabetes Mellitus
Conditions
Brief summary
The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.
Interventions
DRUGInsulin Glargine
Administered SC
DRUGLY3209590
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening * Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²) * Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
Exclusion criteria
* Have an abnormality in the 12-lead ECG * Have a supine blood pressure at screening * Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal (ULN) * Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders * Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy * Have an average weekly alcohol intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Documented Hypoglycemia | Baseline through Day 186 | Incidence of Documented Hypoglycemia |
Countries
Germany
Outcome results
None listed