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A Study of LY3209590 in Participants With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LY3209590

Insulin Glargine

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Miami Research Associates
High Point Clinical Trials Center
LMC Endocrinology Centres Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY3209590

Insulin glargine

Arm Description

Escalating doses of LY3209590 administered by subcutaneous (SC) injection

Insulin glargine administered by SC injection

Outcomes

Primary Outcome Measures

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

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

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

PK: AUC(0-168) of LY3209590

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

PD: Average Glucose from 7-Point Glucose Profiles

Full Information

NCT ID

NCT03367377

First Posted

December 5, 2017

Last Updated

December 10, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03367377

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 3, 2018 (Actual)

Primary Completion Date

October 3, 2018 (Actual)

Study Completion Date

October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3209590

Arm Type

Experimental

Arm Description

Escalating doses of LY3209590 administered by subcutaneous (SC) injection

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

Insulin glargine administered by SC injection

Intervention Type

Drug

Intervention Name(s)

LY3209590

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline through 17 weeks

Secondary Outcome Measure Information:

Title

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

Description

PK: AUC(0-168) of LY3209590

Time Frame

Week 6

Title

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

Description

PD: Average Glucose from 7-Point Glucose Profiles

Time Frame

Baseline, Day 4, Day 40, Day 43

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Miami Research Associates

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

High Point Clinical Trials Center

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27265

Country

United States

Facility Name

LMC Endocrinology Centres Ltd.

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

12. IPD Sharing Statement

Links:

URL

https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/BDCB#?postal=

Description

A Study of LY3209590 in Participants With Type 2 Diabetes

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