A Study of LY3209590 in Participants With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:12/13/2018
Start Date:January 3, 2018
End Date:October 3, 2018

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

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.


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
We found this trial at
3
sites
1929 Bayview Avenue
Toronto, Ontario M4G 3E8
Principal Investigator: Ronnie Aronson
Phone: 4166452929
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Principal Investigator: Martha Hernandez-Illas
Phone: 305-598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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High Point, North Carolina 27265
Principal Investigator: Melanie Fein
Phone: 336-841-0700
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High Point, NC
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