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A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

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ClinicalTrials.gov Identifier: NCT05463744
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetes Drug: Insulin Efsitora Alfa Drug: Insulin Degludec Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 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 Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Actual Study Start Date : August 12, 2022
Estimated Primary Completion Date : April 19, 2024
Estimated Study Completion Date : April 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin Efsitora Alfa
Participants will receive insulin efsitora alfa by subcutaneously (SC)
 Drug: Insulin Efsitora Alfa
Administered SC
Other Name: LY3209590 and Basal Insulin-FC
Active Comparator: Insulin Degludec
Participants will receive 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 ]

Secondary Outcome Measures :
  1. Time in Glucose Range [ Time Frame: Week 22 to Week 26 ]
    Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26

  2. Nocturnal Hypoglycemia Event Rate [ Time Frame: Baseline to Week 52 ]
    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.

  3. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).

  4. Glucose Variability [ Time Frame: Week 22 to Week 26 ]
    Glucose variability measured by CGM 4 weeks prior to week 26

  5. Basal Insulin Dose [ Time Frame: Week 26 ]
  6. Bolus Insulin Dose [ Time Frame: Week 26 ]
  7. Total Insulin Dose [ Time Frame: Week 26 ]
  8. Rate of Composite Level 2 and 3 Hypoglycemia Events [ Time Frame: Baseline to Week 52 ]
  9. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
  10. 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 by CGM 4 weeks prior to week 26.

  11. Time in Hyperglycemia Range [ Time Frame: Week 22 to Week 26 ]
    Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.

  12. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [ Time Frame: Baseline, Week 26 ]
    DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

  13. Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 26 ]
    SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.


Eligibility Criteria
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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 a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
  • Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
  • Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
  • Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

  • Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
  • Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
  • Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months 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): NCT05463744


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
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Chair: 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: NCT05463744    
Other Study ID Numbers: 18263
I8H-MC-BDCY ( Other Identifier: Eli Lilly and Company )
2021-005892-38 ( EudraCT Number )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant 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://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Type 1 Diabetes (T1D)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs