A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, 2-Period, Cross-over, Double- Blind, Single-Dose Study to Evaluate the Effects of LY3532226 on Insulin- Induced Hypoglycemia in Participants With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05887999
• Other study ID #: 18064
• Secondary ID: J2V-MC-GZLC
• Status: Completed
• Phase: Phase 1
• Start date: June 12, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY3532226
Administered subcutaneously (SC).
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	ProSciento, Inc	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predose up to 120 mins postdose
Secondary	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.	Predose up to 120 mins postdose
Secondary	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	Predose up to 120 mins postdose
Secondary	Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT	Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT	Predose up to 120 mins postdose

External Links

•   A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus