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A Study of LY3209590 in Participants With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03367377
Recruitment Status : Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY3209590 Drug: Insulin Glargine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : October 16, 2018
Estimated Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3209590
Escalating doses of LY3209590 administered by subcutaneous (SC) injection
Drug: LY3209590
Administered SC

Active Comparator: Insulin glargine
Insulin glargine administered by SC injection
Drug: Insulin Glargine
Administered SC




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367377


Locations
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
Canada, Ontario
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada, M4G 3E8
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03367377     History of Changes
Other Study ID Numbers: 16392
I8H-MC-BDCB ( Other Identifier: Eli Lilly and Company )
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 17, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs