Back to resultsA Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3532226
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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
Sites / Locations
- ProSciento, IncRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3532226
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05887999
Brief Title
A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3532226
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LY3532226
Intervention Description
Administered subcutaneously (SC).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
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
Description
PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia
Time Frame
Predose up to 120 mins postdose
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)
Description
Change from Baseline in Fasting and Post meal Glucose during sMMTT
Time Frame
Predose up to 120 mins postdose
Title
Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT
Description
Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT
Time Frame
Predose up to 120 mins postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
ProSciento, Inc
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
619-934-6328
First Name & Middle Initial & Last Name & Degree
Victoria Mirza
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://trials.lilly.com/en-US/trial/407539
Description
A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
Learn more about this trial
A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
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