A Study of LY3209590 on Low Blood Sugar in Participants W... | NCT04957914

Studies
A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus

NCT04957914

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Nov 16, 2022Actual

Enrollment

54Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

Insulin Glargine
LY3209590

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I8H-MC-BDCI	Other Identifier	Eli Lilly and Company
2019-003537-42	EudraCT Number

Status Module

Record Verification Date

Nov 1, 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2021Actual

Primary Completion Date

Oct 17, 2022Actual

Completion Date

Oct 17, 2022Actual

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2022

Last Update Posted Date

Nov 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin Glargine (Period 1)	Active Comparator	Insulin glargine administered subcutaneously (SC).	Drug: Insulin Glargine
LY3209590 (Period 2)	Experimental	LY3209590 administered SC.	Drug: LY3209590

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glargine	Drug	Administered SC	Insulin Glargine (Period 1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Documented Hypoglycemia	Incidence of Documented Hypoglycemia	Baseline through Day 186

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening
Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening

Exclusion Criteria:

Have an abnormality in the 12-lead ECG
Have a supine blood pressure at screening
Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit of normal (ULN)
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
Have an average weekly alcohol intake

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Profil Institut für Stoffwechselforschung		Neuss	North Rhine-Westphalia	41460	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38907935	Derived	Heise T, Andersen G, Pratt EJ, Leohr J, Fukuda T, Wang Q, Kazda C, Bue-Valleskey JM, Bergenstal RM. Frequency and Severity of Hypoglycemia Under Conditions of Increased Hypoglycemic Risk with Insulin Efsitora Alfa Versus Insulin Glargine Treatment in Participants with Type 2 Diabetes. Diabetes Ther. 2024 Aug;15(8):1785-1797. doi: 10.1007/s13300-024-01605-7. Epub 2024 Jun 22.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones