A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: LY3532226
|
Drug: LY3532226
Administered subcutaneously (SC).
|
Placebo Comparator: Placebo
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Drug: Placebo
Administered SC.
|
Outcome Measures
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 [Predose up to 120 mins postdose]
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. [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.
- 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
- 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
Inclusion Criteria:
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Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin
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Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
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Are males or females not of childbearing potential
Exclusion Criteria:
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Have acute proliferative retinopathy requiring active treatment within 3 months of screening
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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
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Have received systemic or inhaled glucocorticoid therapy
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Women of childbearing potential
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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.- 18064
- J2V-MC-GZLC