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Type 2 Diabetes MellitusPhase 2NCT03736785

A 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 44 sites in 3 countries.

Completed

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

Official record
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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 that have already been treated with basal insulin. Read more about this study

Who is it for?
Ages 18 years and older
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
399 participants
Where
44 sitesin 3 countries
Study dates
15 Nov 2018to 18 Feb 2020
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

  • Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • sodium-glucose cotransporter (SGLT-2) inhibitors
  • biguanides
  • alpha-glucosidase inhibitors
  • sulfonlyureas
  • HbA1c value of 6.5% to 10%, inclusive
  • Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Who cannot join

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

Trial locations and contacts

44 sites in 3 countries.

44 sites in 3 countries

United States37 sites

  • Internal Medicine Associates of Anderson

    Anderson, South Carolina, 29621

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731-4309

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Elite Clinical Trials LLLP

    Blackfoot, Idaho, 83221

  • Metrolina Internal Medicine, P.A.

    Charlotte, North Carolina, 28207

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • AMCR Institute INC

    Escondido, California, 92025

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Valley Endocrine, Fresno

    Fresno, California, 93720

  • Marin Endocrine Associates

    Greenbrae, California, 94904

  • East West Medical Institute

    Honolulu, Hawaii, 96814

  • National Research Institute

    Huntington Park, California, 90255

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • First Valley Medical Group

    Lancaster, California, 93534

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • National Research Institute

    Los Angeles, California, 90057

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • The Research Center of the Upstate

    Mauldin, South Carolina, 29662

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03063

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Intend Research

    Norman, Oklahoma, 73069

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Preferred Primary Care Physicians - Jacob Murphy Lane

    Uniontown, Pennsylvania, 15401

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Confluence Health Clinical Research Department

    Wenatchee, Washington, 98801

  • Iderc, P.L.C.

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico5 sites

  • Advanced Clinical Research, LLC

    Bayamón, PR, 00961

  • Manati Center for Clinical Research Inc

    Manati, PR, 00674

  • GCM Medical Group PSC

    San Juan, PR, 00917

  • Martha Gomez Cuellar M.D.

    San Juan, PR, 00921

  • Centro de Endocrinologia del Este

    Yabucoa, 00767

Other trials in Puerto Rico

Mexico2 sites

  • Investigacion en Salud y Metabolismo S.C

    Chihuahua City, 31217

  • Hospital Universitario UANL

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

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 NCT03736785
Study groupRoleWhat they receive
LY3209590 Algorithm 1ExperimentalParticipants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram per deciliter (mg/dL).
Receives: Drug: LY3209590
LY3209590 Algorithm 2ExperimentalParticipants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Receives: Drug: LY3209590
Insulin DegludecActive comparatorParticipants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
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 HbA1c

    HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.

    Measured: Baseline, Week 32

Secondary outcomes (7)

  1. Change From Baseline in HbA1c Compared to Insulin Degludec

    HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.

    Measured: Baseline, Week 32

  2. Change From Baseline in Fasting Glucose

    Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.

    Measured: Baseline, Week 32

  3. Change From Baseline in Insulin Dose (LY3209590)

    The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.

    Measured: Week 1, Week 32

  4. Change From Baseline in Insulin Dose (Insulin Degludec)

    Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.

    Measured: Baseline, Week 32

  5. Rate of Total Documented Symptomatic Hypoglycemia

    The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.

    Measured: Baseline through week 32

  6. Change From Baseline in Body Weight

    Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.

    Measured: Baseline, Week 32

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

    PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.

    Measured: Week 32

Timeline

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

  1. First posted9 Nov 2018
  2. Study start15 Nov 2018
  3. Primary completion18 Feb 2020
  4. Study completion18 Feb 2020

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
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03736785
Sponsor's protocol ID
17059
Other IDs
I8H-MC-BDCM
Status last verified
Mar 2020
First submitted
2 Nov 2018
Last updated
8 Mar 2021
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

  • Frias J, Chien J, Zhang Q, Chigutsa E, Landschulz W, Syring K, Wullenweber P, Haupt A, Kazda C. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. 2023 Mar;11(3):158-168. doi: 10.1016/S2213-8587(22)00388-6. Epub 2023 Feb 6.

    PubMed 36758572

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 44 sites in 3 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 8 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Puerto Rico, Mexico. 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 8 Mar 2021). 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 HbA1c (time frame: Baseline, Week 32). 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 NCT03736785, 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 8 Mar 2021.

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