A Study of LY3209590 in Participants With Type 2 Diabetes
NCT ID: NCT03367377
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2018-01-03
2018-10-03
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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LY3209590
Escalating doses of LY3209590 administered by subcutaneous (SC) injection
LY3209590
Administered SC
Insulin glargine
Insulin glargine administered by SC injection
Insulin Glargine
Administered SC
Interventions
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LY3209590
Administered SC
Insulin Glargine
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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A Study of LY3209590 in Participants With Type 2 Diabetes
Other Identifiers
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I8H-MC-BDCB
Identifier Type: OTHER
Identifier Source: secondary_id
16392
Identifier Type: -
Identifier Source: org_study_id