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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05275400
Recruitment Status : Active, not recruiting
First Posted : March 11, 2022
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 3, 2022
First Posted Date  ICMJE March 11, 2022
Last Update Posted Date January 23, 2023
Actual Study Start Date  ICMJE March 8, 2022
Estimated Primary Completion Date May 14, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
  • 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.
  • 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.
  • Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 26 ]
    Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).
  • 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.
  • 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.
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 78 ]
    Change from baseline in body weight
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: LY3209590
    Administered SC
  • Drug: Insulin Degludec
    Administered SC
Study Arms  ICMJE
  • Experimental: LY3209590
    Participants will be given LY3209590 subcutaneously (SC).
    Intervention: Drug: LY3209590
  • Active Comparator: Insulin Degludec
    Participants with be given insulin degludec SC.
    Intervention: Drug: Insulin Degludec
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 9, 2022)
1228
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2022)
939
Estimated Study Completion Date  ICMJE May 14, 2024
Estimated Primary Completion Date May 14, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Hungary,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05275400
Other Study ID Numbers  ICMJE 18237
I8H-MC-BDCU ( Other Identifier: Eli Lilly and Company )
2021-002569-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP