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A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)

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ClinicalTrials.gov Identifier: NCT05462756
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : March 23, 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 evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Type 2 Diabetes Treated With Insulin Drug: Insulin Efsitora Alfa Drug: Insulin Lispro (U100) Drug: Insulin Glargine (U100) 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, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections
Actual Study Start Date : August 11, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin Efsitora Alfa + Insulin Lispro
Participants will be given insulin efsitora alfa by subcutaneous (SC) injection along with insulin lispro
 Drug: Insulin Efsitora Alfa
Administered SC
Other Name: LY3209590 and Basal Insulin-FC

Drug: Insulin Lispro (U100)
Administered SC
Other Name: Humalog
Active Comparator: Insulin Glargine + Insulin Lispro
Participants will be given insulin glargine by SC injection along with insulin lispro
 Drug: Insulin Lispro (U100)
Administered SC
Other Name: Humalog

Drug: Insulin Glargine (U100)
Administered SC
Other Name: Basaglar


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in HbA1c [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin glargine on glycemic control in adult participants with type 2 diabetes on multiple daily injections.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving HbA1c <7% without Nocturnal Hypoglycemia [ Time Frame: Week 26 ]
    Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia milligram/deciliter (mg/dL) [3.0 millimole/Liter (mmol/L) or severe] during treatment phase up to week 26.

  2. Nocturnal Hypoglycemia Event Rate [ Time Frame: Baseline to Week 26 ]
    The event rate of participant-reported clinically significant nocturnal hypoglycemia <54 mg/dL (3.0 mmol/L) or severe) measured during treatment phase up to week 26.

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

  4. Time in Glucose Range [ Time Frame: Week 22 to Week 26 ]
    Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session

  5. Time in Hypoglycemia Range [ Time Frame: Week 22 to Week 26 ]
    Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM

  6. Time in Hyperglycemia Range [ Time Frame: Week 22 to Week 26 ]
    Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM

  7. Glucose Variability [ Time Frame: Week 22 to Week 26 ]
    Glucose variability measured during the CGM session

  8. Basal Insulin Dose [ Time Frame: Week 26 ]
  9. Bolus Insulin Dose [ Time Frame: Week 26 ]
  10. Total Insulin Dose [ Time Frame: Week 26 ]
  11. Basal Insulin Dose to Total Insulin Dose Ratio [ Time Frame: Week 26 ]
  12. Hypoglycemia Event Rate [ Time Frame: Baseline to Week 26 ]
    Incidence and rate of composite of level 2 and 3 hypoglycemia event

  13. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
  14. Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ) [ Time Frame: Week 26 ]
    The DID-EQ is a self-administered 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for T2D. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics.


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 diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
  • Are receiving ≥10 units of total basal insulin per day at screening.
  • Are receiving ≤2 units/kilogram/day of total daily insulin at screening
  • Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening

  • Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening

    • once daily U-100 or U-200 insulin degludec
    • once daily U-100 or U-300 insulin glargine
    • once or twice daily U-100 insulin detemir or
    • once or twice daily human insulin Neutral Protamine Hagedorn

  • Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.

    • Insulin lispro-aabc
    • Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
    • Insulin aspart (U-100)
    • Insulin glulisine (U-100), or
    • Regular insulin (U-100)

  • Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening

    • dipeptidyl peptidase IV inhibitors
    • sodium-glucose co-transporter-2 inhibitors
    • biguanides (for example, metformin), or
    • glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
    • Have a body mass index ≤45 kilogram/square meter (kg/m²)

Exclusion Criteria:

  • Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).

  • Are currently receiving any of the following insulin therapies anytime in the past 90 days:

    • insulin mixtures
    • insulin human, inhalation powder, or
    • continuous subcutaneous insulin infusion therapy, or
    • regular insulin U-500
  • Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
  • Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
  • Have hypoglycemia unawareness in the opinion of the investigator
  • Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
  • Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
  • Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, 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): NCT05462756


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 Director: Call 1-877-CTLILLY (1-877-285-4559) 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: NCT05462756    
Other Study ID Numbers: 18260
I8H-MC-BDCV ( Other Identifier: Eli Lilly and Company )
2021-005878-25 ( EudraCT Number )
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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
 Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs