A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Eli Lilly and Company30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

LY3532226DRUG

Administered subcutaneously (SC).

PlaceboDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

ProSciento, Inc

Chula Vista, California, United States

Outcomes

Primary Outcomes

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

PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia

Time frame: Predose up to 120 mins postdose

Secondary Outcomes

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.

The amount of exogenous glucose infused to maintain a plasma glucose level of \>2.5 mmol/L, after the insulin infusion is terminated.

Time frame: Predose up to 120 mins postdose

Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)

Change from Baseline in Fasting and Post meal Glucose during sMMTT

Time frame: Predose up to 120 mins postdose

Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

Time frame: Predose up to 120 mins postdose

Data from ClinicalTrials.gov

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