Diabetes Mellitus, Type 1
Conditions
Brief summary
The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM). The study will also evaluate if LY3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. The study will last approximately 16 weeks excluding screening period.
Interventions
DRUGLY3532226
Administered subcutaneously (SC).
DRUGPlacebo
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin * Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²) * Are males or females not of childbearing potential
Exclusion criteria
* Have acute proliferative retinopathy requiring active treatment within 3 months of screening * Have been treated with dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months * Have received systemic or inhaled glucocorticoid therapy * Women of childbearing potential * Are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia | Predose up to 120 mins postdose | PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 millimole per liter (mmol/L), after the insulin infusion is terminated. | Predose up to 120 mins postdose | The amount of exogenous glucose infused to maintain a plasma glucose level of \>2.5 mmol/L, after the insulin infusion is terminated. |
| Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT) | Predose up to 120 mins postdose | Change from Baseline in Fasting and Post meal Glucose during sMMTT |
| Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT | Predose up to 120 mins postdose | Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT |
Countries
United States
Outcome results
None listed