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OpenTrials
Completed

NCT Number: NCT05887999

A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ProSciento, Inc

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3532226

Drug

Administered subcutaneously (SC).

Placebo

Drug

Administered SC.

Primary outcomes

  1. 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

    Time frame: Predose up to 120 mins postdose

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

Secondary outcomes

  1. 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.

    Time frame: 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.

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

    Time frame: Predose up to 120 mins postdose

    Change from Baseline in Fasting and Post meal Glucose during sMMTT

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

    Time frame: Predose up to 120 mins postdose

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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