A Study of LY3209590 in Participants With Type 2 Diabetes

Phase 1

Completed

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

• Registration Number: NCT03367377
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented.

This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-08
• Study Start: 2018-01-03
• Primary Completion: 2018-10-03
• Study Completion: 2018-10-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
• Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening
• Have had no episodes of severe hypoglycemia in the past 6 months
• Are on stable basal insulin (neutral protamine Hagedorn insulin suspension [NPH] insulin, insulin glargine [U100 or U300], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening

Read More

Exclusion Criteria

• Have significant lipohypertrophy in the target abdominal injection
• Have a history of renal impairment
• Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children)
• Have proliferative retinopathy or maculopathy and/or severe neuropathy
• Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening
• Require daily insulin treatment less than (<) 0.15 unit/kilogram (U/kg) per body weight
• Are treated with a continuous subcutaneous insulin infusion (CSII) pump
• Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590	LY3209590	Escalating doses of LY3209590 administered by subcutaneous (SC) injection
Insulin glargine	Insulin Glargine	Insulin glargine administered by SC injection

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 17 weeks	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
Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590	Week 6	PK: AUC(0-168) of LY3209590
Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles	Baseline, Day 4, Day 40, Day 43	PD: Average Glucose from 7-Point Glucose Profiles

Trial Locations

Locations (3)

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

High Point Clinical Trials Center; 🇺🇸 High Point, North Carolina, United States

LMC Endocrinology Centres Ltd.; 🇨🇦 Toronto, Ontario, Canada