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Type 2 Diabetes MellitusPhase 2NCT04450394

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

A Phase 2 study testing LY3209590 and Insulin Degludec in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 64 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
LY3209590 and Insulin Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
64 sitesin 5 countries
Study dates
1 Jul 2020to 8 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

64 sites in 5 countries.

64 sites in 5 countries

United States31 sites

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731-4309

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida, 33312

  • Juno Research

    Houston, Texas, 77040

  • Juno Research - Gessner

    Houston, Texas, 77074

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • National Research Institute - Wilshire

    Los Angeles, California, 90057

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Suncoast Research Group

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165 3338

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Elite Clinical Trials

    Rexburg, Idaho, 83440

  • Sky Clin Resch - Quinn HC

    Ridgeland, Mississippi, 39157

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Syed Research Consultants Llc

    Sheffield, Alabama, 35660

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • Rophe Adult and Pediatric Medicine

    Union City, Georgia, 30291

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • CMR of Greater New Haven

    Waterbury, Connecticut, 06708

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Argentina11 sites

  • CEMEDIC

    Buenos Aires, 1407

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN

  • Consultorio de Investigación Clínica EMO SRL

    Caba, Buenos Aires, C1405BUB

  • Centro Médico Viamonte

    CABA, Buenos Aires, C1120AAC

  • Investigaciones Medicas Imoba Srl

    CABA, Buenos Aires, C1179AAB

  • Fundacion Sanatorio Guemes

    CABA, Buenos Aires, C1180AAX

  • CEDIC

    CABA, Buenos Aires, C1425DES

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

    Córdoba, X5008HHW

  • Instituto Médico Catamarca

    Rosario, Santa Fe Province, 2000

  • Clínica Mayo

    San Miguel de Tucumán, T4000IHE

Other trials in Argentina

Poland11 sites

  • Centrum Kliniczno-Badawcze

    Elblag, 82-300

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship, 31-261

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90242

  • Gabinety TERPA

    Lublin, 20-333

  • OMEDICA Medical Center

    Poznan, 60-111

  • Praktyka Lekarska

    Poznan, 61-655

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Śląska, Silesian Voivodeship, 41-709

  • Instytut Diabetologii Sp. z o.o

    Warsaw, Masovian Voivodeship, 02-117

  • Poradnia Chorob Metabolicznych

    Wierzchosławice, 33-122

  • NZOZ Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127

Other trials in Poland

Germany8 sites

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, North Rhine-Westphalia, 44869

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • Practice Dr.med. Denger and Dr.med. Pfitzner

    Friedrichsthal, Saarland, 66299

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • SMO.MD GmbH

    Magdeburg, Saxony-Anhalt, 39120

  • Institut für Diabetesforschung GmbH Münster

    Münster, North Rhine-Westphalia, 48145

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Private Practice - Dr. Christine Kosch

    Pirna, Saxony, 01796

Other trials in Germany

Puerto Rico3 sites

  • Research and Cardiovascular Corp.

    Ponce, PR, 00717

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

  • Centro Profesional de Endocrinologia del Este

    Yabucoa, PR, 00767

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
LY3209590, Insulin Degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3209590Drug

    Administered SC

  • Insulin DegludecDrug

    Administered SC

Study groups in NCT04450394
Study groupRoleWhat they receive
LY3209590 Algorithm 1 (Paper)ExperimentalAlgorithm 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).
Receives: Drug: LY3209590
LY3209590 Algorithm 2 (Digital)ExperimentalAlgorithm 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.
Receives: Drug: LY3209590
Insulin DegludecActive comparatorInsulin 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.
Receives: Drug: Insulin Degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    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.

    Measured: Baseline, Week 26

Secondary outcomes (3)

  1. Change From Baseline in Fasting Serum Glucose

    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.

    Measured: Baseline, Week 26

  2. Rate of Documented Hypoglycemia

    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.

    Measured: Baseline through Week 26

  3. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

    AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start1 Jul 2020
  3. Primary completion8 Oct 2021
  4. Study completion8 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450394
Sponsor's protocol ID
17056
Other IDs
I8H-MC-BDCL, 2019-003339-53, 2019
Status last verified
Oct 2022
First submitted
26 Jun 2020
Last updated
2 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bue-Valleskey JM, Kazda CM, Ma C, Chien J, Zhang Q, Chigutsa E, Landschulz W, Haupt A, Frias JP. Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Diabetes Care. 2023 May 1;46(5):1060-1067. doi: 10.2337/dc22-2396.

    PubMed 36944059

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3209590 and Insulin Degludec in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 64 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Argentina, Poland, Germany, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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