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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450394
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: LY3209590 Drug: Insulin Degludec Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 23, 2021
Estimated Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3209590 Algorithm 1
LY3209590 administered subcutaneously (SC).
Drug: LY3209590
Administered SC

Active Comparator: Insulin Degludec
Insulin degludec administered SC.
Drug: Insulin Degludec
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c


Secondary Outcome Measures :
  1. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Fasting Glucose

  2. Rate of Documented Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of Documented Hypoglycemia

  3. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [ Time Frame: Baseline through Week 26 ]
    PK: AUC of LY3209590



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450394


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Show Show 65 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04450394    
Other Study ID Numbers: 17056
I8H-MC-BDCL ( Other Identifier: Eli Lilly and Company )
2019-003339-53 ( EudraCT Number )
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs