A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY3209590; Drug: Insulin Degludec

• Registration Number: NCT04276428
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Study Start: 2020-02-28
• Primary Completion: 2020-11-28
• Study Completion: 2020-11-28
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Have type 2 diabetes mellitus (T2DM) for at least 1 year
• Have received a stable daily dose of basal insulin at screening
• Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
• Have a body mass index greater than (>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Exclusion Criteria

• Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body weight at screening
• Have received insulins except for basal insulins
• Have received sulfonylurea at more than half of the maximum approved dose level
• Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
• Have had more than 1 episode of severe hypoglycemia within 6 months before entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590	LY3209590	LY3209590 administered subcutaneously (SC).
Insulin Degludec	Insulin Degludec	Insulin degludec administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 85	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	Day 1 through Day 85	PD: Change from Baseline in Fasting Plasma Glucose
Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590	Predose on Day 1 through Day 85	PK: AUC(0-168) of LY3209590

Trial Locations

Locations (3)

Yokohama Minoru Clinic; 🇯🇵 Yokohama, Japan

Clinical Research Hospital Tokyo; 🇯🇵 Shinjuku-ku, Jp-13, Japan

P-one clinic; 🇯🇵 Hachioji, Tokyo, Japan