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A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

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ClinicalTrials.gov Identifier: NCT05275400
Recruitment Status : Active, not recruiting
First Posted : March 11, 2022
Last Update Posted : February 7, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: LY3209590 Drug: Insulin Degludec Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 986 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
Actual Study Start Date : March 8, 2022
Estimated Primary Completion Date : May 14, 2024
Estimated Study Completion Date : May 14, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3209590
Participants will be given LY3209590 subcutaneously (SC).
 Drug: LY3209590
Administered SC
Active Comparator: Insulin Degludec
Participants with be given insulin degludec SC.
 Drug: Insulin Degludec
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c of LY3209590 compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin.


Secondary Outcome Measures :
  1. Nocturnal Hypoglycemia Event Rate [ Time Frame: Baseline to Week 78 ]
    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78.

  2. Time in Range [ Time Frame: Week 22 to Week 26 ]
    Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.

  3. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 26 ]
    Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).

  4. Weekly Insulin dose [ Time Frame: Week 26 ]
    The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.

  5. Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate [ Time Frame: Baseline to Week 78 ]
    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.

  6. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 78 ]
    Change from baseline in body weight

  7. Time in Hypoglycemia Range [ Time Frame: Week 22 to Week 26 ]
    Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL measured during the CGM session.

  8. Time in Hyperglycemia Range [ Time Frame: Week 22 to Week 26 ]
    Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session.

  9. Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) [ Time Frame: Baseline, Week 26 ]
    TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.

  10. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [ Time Frame: Baseline, Week 26 ]
    DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

  11. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [ Time Frame: Baseline, Week 78 ]
    DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
  • Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
  • Have HbA1c value of 6.5% - 10% inclusive, at screening
  • Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)

  • Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

    • once daily U100 or U200 of insulin degludec
    • once daily U100 or U300 of insulin glargine
    • once or twice daily U100 of insulin detemir, or
    • once or twice daily human insulin NPH

  • acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

    • dipeptidyl peptidase (DPP-4) IV inhibitors
    • SGLT2 inhibitors
    • metformin
    • alphaglucosidase inhibitors or,
    • Glucagon-Like Peptide-1 (GLP-1) receptor agonists
    • Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

  • Have Type 1 diabetes mellitus
  • Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
  • Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
  • Have active or untreated malignancy
  • Are pregnant
  • Have a significant weight gain or loss the past 3 months

  • Have received anytime in the past 6 months, any of the following insulin therapies:

    • prandial insulin
    • insulin mixtures
    • inhaled insulin
    • U-500 insulin, or
    • continuous subcutaneous insulin infusion therapy

  • Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

    • acute myocardial infarctions
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery
  • Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Contacts and Locations
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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): NCT05275400


Locations
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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 - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05275400    
Other Study ID Numbers: 18237
I8H-MC-BDCU ( Other Identifier: Eli Lilly and Company )
2021-002569-16 ( EudraCT Number )
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: February 7, 2023
Last Verified: February 2023
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 European Union (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://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