A Study of LY3209590 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367377
• Other study ID #: 16392
• Secondary ID: I8H-MC-BDCB
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2018
• Est. completion date: October 3, 2018

Study information

• Verified date: December 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 3, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3209590
Administered SC
• Insulin Glargine
Administered SC

Locations

Country	Name	City	State
Canada	LMC Endocrinology Centres Ltd.	Toronto	Ontario
United States	High Point Clinical Trials Center	High Point	North Carolina
United States	Miami Research Associates	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 17 weeks
Secondary	Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590	PK: AUC(0-168) of LY3209590	Week 6
Secondary	Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles	PD: Average Glucose from 7-Point Glucose Profiles	Baseline, Day 4, Day 40, Day 43

External Links

•   A Study of LY3209590 in Participants With Type 2 Diabetes