Status:
COMPLETED
A Study of LY3209590 in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03367377
Start Date
January 3 2018
End Date
October 3 2018
Last Update
December 11 2018
Active Locations (3)
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1
Miami Research Associates
South Miami, Florida, United States, 33143
2
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
3
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada, M4G 3E8