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OpenTrials
Completed

NCT Number: NCT03367377

A Study of LY3209590 in Participants With Type 2 Diabetes

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LMC Endocrinology Centres Ltd., Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3209590

Drug

Administered SC

insulin glargine

Drug

Administered SC

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through 17 weeks

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590

    Time frame: Week 6

    PK: AUC(0-168) of LY3209590

  2. Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles

    Time frame: Baseline, Day 4, Day 40, Day 43

    PD: Average Glucose from 7-Point Glucose Profiles

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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