A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

October 6, 2022 updated by: Eli Lilly and Company

A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1407
        • CEMEDIC
      • Buenos Aires, Argentina, C1419AHN
        • Asociación de Beneficencia Hospital Sirio Libanés
      • Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
        • Instituto Centenario
      • Cordoba, Argentina, X5008HHW
        • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
      • Tucuman, Argentina, T4000IHE
        • Clínica Mayo
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1120AAC
        • Centro Médico Viamonte
      • Caba, Buenos Aires, Argentina, C1179AAB
        • Investigaciones Medicas Imoba Srl
      • Caba, Buenos Aires, Argentina, C1180AAX
        • Fundacion Sanatorio Güemes
      • Caba, Buenos Aires, Argentina, C1405BUB
        • Consultorio de Investigación Clínica EMO SRL
      • Caba, Buenos Aires, Argentina, C1425DES
        • CEDIC
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Medico Catamarca
      • Hamburg, Germany, 22607
        • Diabeteszentrum Hamburg West
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44869
        • Diabetes- und Stoffwechselpraxis Bochum
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Münster, Nordrhein-Westfalen, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
    • Saarland
      • Friedrichsthal, Saarland, Germany, 66299
        • Practice Dr.med. Denger and Dr.med. Pfitzner
    • Sachsen
      • Pirna, Sachsen, Germany, 01796
        • Private Practice - Dr. Christine Kosch
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • SMO.MD GmbH
    • Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • RED-Institut GmbH
      • Elblag, Poland, 82-300
        • Centrum Kliniczno-Badawcze
      • Lodz, Poland, 90242
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
      • Lublin, Poland, 20-333
        • Gabinety TERPA
      • Poznan, Poland, 61-655
        • Praktyka Lekarska
      • Poznan, Poland, 60-111
        • OMEDICA Medical Center
      • Wierzchosławice, Poland, 33-122
        • Poradnia Chorob Metabolicznych
      • Wroclaw, Poland, 50-127
        • NZOZ Regionalna Poradnia Diabetologiczna
    • Masovian
      • Warsaw, Masovian, Poland, 02-117
        • Instytut Diabetologii Sp. z o.o
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House Sp. z o.o.
    • Slaskie
      • Ruda Slaska, Slaskie, Poland, 41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
      • Ponce, Puerto Rico, 00717
        • Research and Cardiovascular Corp.
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
      • Yabucoa, Puerto Rico, 00767
        • Centro Profesional de Endocrinologia del Este
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Syed Research Consultants Llc
    • California
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • CMR of Greater New Haven
    • Florida
      • Cooper City, Florida, United States, 33024
        • ALL Medical Research, LLC
      • Fort Lauderdale, Florida, United States, 33312
        • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
      • Miami, Florida, United States, 33135
        • Suncoast Research Group
      • Miami, Florida, United States, 33165 3338
        • New Horizon Research Center
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
    • Georgia
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
      • Rexburg, Idaho, United States, 83440
        • Elite Clinical Trials
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes and Endocrinology Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Sky Clin Resch - Quinn HC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
    • Texas
      • Austin, Texas, United States, 78731-4309
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Houston, Texas, United States, 77040
        • Juno Research
      • Houston, Texas, United States, 77074
        • Juno Research - Gessner
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
  • Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
  • Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

  • Have type 1 diabetes mellitus or latent autoimmune diabetes
  • Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
  • Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
  • Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
  • Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²
  • Have active or untreated cancer
  • Are receiving chronic (>14 days) systemic glucocorticoid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3209590 Algorithm 1 (Paper)
Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the baseline median fasting glucose and body weight by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).
Administered SC
Experimental: LY3209590 Algorithm 2 (Digital)

Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the baseline median fasting glucose and body weight by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.

Administered SC
Active Comparator: Insulin Degludec
Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 26
HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 26
LS mean change from baseline was analysed by MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.
Baseline, Week 26
Rate of Documented Hypoglycemia
Time Frame: Baseline through Week 26
Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose <54 mg/dL (3.0 millimole per liter (mmol/L)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period*365.25 days.
Baseline through Week 26
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Time Frame: Week 26
AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 - 5hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

October 8, 2021

Study Completion (Actual)

October 8, 2021

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 17056
  • I8H-MC-BDCL (Other Identifier: Eli Lilly and Company)
  • 2019-003339-53 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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