Clinical trial NCT03367377: A Study of LY3209590 in Participants With Type 2 Diabetes
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through 17 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590
timeFrame: Week 6
measure: Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles
timeFrame: Baseline, Day 4, Day 40, Day 43
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: Toronto
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: