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Type 1 Diabetes MellitusPhase 2NCT04450407

A Study of LY3209590 in Participants With Type 1 Diabetes

A Phase 2 study testing LY3209590 and Insulin Degludec in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 54 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 1 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 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
266 participants
Where
54 sitesin 5 countries
Study dates
6 Jul 2020to 1 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
  • Participants must have been using multiple daily injections without interruption for at least 3 months
  • Participants must have HbA1c values of 5.6% to 9.5%, inclusive
  • Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)

Who cannot join

  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
  • 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

54 sites in 5 countries.

54 sites in 5 countries

United States33 sites

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731-4309

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Univ Diab & Endo Consult

    Chattanooga, Tennessee, 37411

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Denver Endocrinology, Diabetes & Thyroid Center

    Englewood, Colorado, 80113

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • Valley Endocrine, Fresno

    Fresno, California, 93720

  • Endocrine and Psychiatry Center

    Houston, Texas, 77095

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • East Coast Institute for Research at The Jones Center

    Jacksonville, Florida, 32204

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • East Coast Institute for Research at The Jones Center

    Macon, Georgia, 31210

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Diabetes and Metabolism Associates, APMC

    Metairie, Louisiana, 70006

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Southern Nh Diabetes and Endocrinology

    Nashua, New Hampshire, 03060

  • Sun Coast Clinical Research, Inc

    New Port Richey, Florida, 34652

  • Bayside Clinical Research, LLC

    New Port Richey, Florida, 34655

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • PMG Research of Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Suny Health Science Center at Syracuse

    Syracuse, New York, 13210

  • Coastal Metabolic Research Centre

    Ventura, California, 93003

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Germany8 sites

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • Praxis Dr. Jörg Lüdemann

    Falkensee, Brandenburg, 14612

  • 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

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland, 66386

Other trials in Germany

Spain7 sites

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    A Coruña, 15006

  • Centro Periférico de Especialidades Bola Azul

    Almería, 04009

  • Hospital Universitario de La Ribera

    Alzira, Valencia, 46600

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Quiron Infanta Luisa

    Seville, Andalusia, 41010

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

  • Hospital Universitario Virgen Macarena

    Seville, 41007

Other trials in Spain

Austria3 sites

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • Klinik Landstraße

    Vienna, 1030

  • Zentrum für klinische Studien Dr Hanusch Gmbh

    Vienna, 1060

Other trials in Austria

Puerto Rico3 sites

  • Dr Altagracia Aurora Alcantara Gonzalez

    Bayamón, PR, 00956

  • Advanced Clinical Research, LLC

    Bayamón, PR, 00961

  • Martha Gomez Cuellar M.D.

    San Juan, PR, 00921

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

Being tested
LY3209590, Insulin Degludec
Medical subject headings
Diabetes Mellitus, Type 1

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 NCT04450407
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 basal insulin dose prior randomization and baseline fasting glucose 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 basal insulin dose prior randomization and baseline fasting glucose 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 same as basal insulin dose prior randomization, 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, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.

    Measured: Baseline, Week 26

Secondary outcomes (4)

  1. Change From Baseline in Fasting Serum Glucose

    LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.

    Measured: Baseline, Week 26

  2. Change From Baseline in Bolus Insulin Dose

    Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate.

    Measured: Baseline, Week 26

  3. 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)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants.

    Measured: Baseline through Week 26

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

    AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the 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 start6 Jul 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 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
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450407
Sponsor's protocol ID
17183
Other IDs
I8H-MC-BDCP, 2019-003589-41, 2019
Status last verified
Sep 2022
First submitted
26 Jun 2020
Last updated
27 Oct 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3209590 and Insulin Degludec in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 54 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 4 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Germany, Spain, Austria, 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 27 Oct 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 NCT04450407.

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 27 Oct 2022.

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