NCT04957914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2021

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

July 8, 2021

Last Update Submit

November 15, 2022

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Incidence of Documented Hypoglycemia

    Incidence of Documented Hypoglycemia

    Baseline through Day 186

Study Arms (2)

Insulin Glargine (Period 1)

ACTIVE COMPARATOR

Insulin glargine administered subcutaneously (SC).

Drug: Insulin Glargine

LY3209590 (Period 2)

EXPERIMENTAL

LY3209590 administered SC.

Drug: LY3209590

Interventions

Insulin GlargineDRUG

Administered SC

Insulin Glargine (Period 1)
LY3209590DRUG

Administered SC

LY3209590 (Period 2)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38907935DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 12, 2021

Study Start

July 14, 2021

Primary Completion

October 17, 2022

Study Completion

October 17, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)