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

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

Tracking Information

• First Submitted Date: March 3, 2022
• First Posted Date: March 11, 2022
• Last Update Posted Date: January 23, 2023
• Actual Study Start Date: March 8, 2022
• Estimated Primary Completion Date: May 14, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
• 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)
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• Drug: LY3209590
  Administered SC
• Drug: Insulin Degludec
  Administered SC

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 9, 2022): 1228
• Original Estimated Enrollment (submitted: March 3, 2022): 939
• Estimated Study Completion Date: May 14, 2024
• Estimated Primary Completion Date: May 14, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Hungary, Japan, Korea, Republic of, Poland, Puerto Rico, Slovakia, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT05275400
• Other Study ID Numbers: 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

• 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: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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