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A 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: NCT03736785
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : February 5, 2019
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 that have already been treated with basal insulin.

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 : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 25, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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

Experimental: LY3209590 Algorithm 2
LY3209590 administered SC.
Drug: LY3209590
Administered SC

Experimental: 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 32 ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c Compared to Insulin Degludec [ Time Frame: Baseline, Week 32 ]
    Change from baseline in HbA1c compared to insulin degludec

  2. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 32 ]
    Change from baseline in fasting glucose

  3. Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 32 ]
    Change from baseline in insulin dose

  4. Rate of Total Documented Symptomatic Hypoglycemia [ Time Frame: Week 32 ]
    Rate of total documented symptomatic hypoglycemia

  5. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 32 ]
    Change from baseline in body weight

  6. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [ Time Frame: Week 32 ]
    PK: AUC of LY3209590



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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03736785


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

  Show 45 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: NCT03736785     History of Changes
Other Study ID Numbers: 17059
I8H-MC-BDCM ( Other Identifier: Eli Lilly and Company )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
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: http://www.clinicalstudydatarequest.com

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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
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs