A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05887999
Collaborator
(none)
30
1
2
8.6
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Jan 8, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3532226

Drug: LY3532226
Administered subcutaneously (SC).

Placebo Comparator: Placebo

Drug: Placebo
Administered SC.

Outcome Measures

Primary Outcome Measures

  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 [Predose up to 120 mins postdose]

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

Secondary Outcome Measures

  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. [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) [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 [Predose up to 120 mins postdose]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProSciento, Inc Chula Vista California United States 91911

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05887999
Other Study ID Numbers:
  • 18064
  • J2V-MC-GZLC
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023