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    Summary
    EudraCT Number:2021-005878-25
    Sponsor's Protocol Code Number:I8H-MC-BDCV
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-005878-25
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of LY3209590 Compared with Daily Insulin Glargine in Adults with Type 2 Diabetes on Multiple Daily Injections
    A.3.2Name or abbreviated title of the trial where available
    QWINT-4
    A.4.1Sponsor's protocol code numberI8H-MC-BDCV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInsulin Efsitora Alfa
    D.3.2Product code LY3209590
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY3209590
    D.3.9.3Other descriptive nameLY3209590
    D.3.9.4EV Substance CodeSUB183882
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abasaglar
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInsulin Glargine
    D.3.2Product code A10AE04
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin glargine
    D.3.9.1CAS number 160337-95-1
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes Mellitus, Type 2
    E.1.1.1Medical condition in easily understood language
    Diabetes Mellitus, Type 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate noninferiority of LY3209590 compared to insulin glargine on glycemic control.
    E.2.2Secondary objectives of the trial
    Demonstrate LY3209590 is superior to insulin glargine in the selected parameters of glycemic control.
    To investigate the effect of LY3209590 compared with insulin glargine in additional parameters of diabetes management.
    To investigate the safety of LY3209590 compared with insulin glargine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Are ≥18 years of age, at screening (Visit 1), per local regulations.
    •Have a diagnosis of type 2 diabetes mellitus (T2D) treated with basal insulin and at least two injections of prandial insulin per day
    •Are receiving ≥10 units of basal insulin per day at screening (Visit 1)
    •Are receiving less than or equal to 2 units/kg/day of total daily insulin at screening (Visit 1)
    •Have an HbA1c value of 7.0% to 10% inclusive at screening
    •Have been treated with a stable regimen of one of the following basal insulins for at least 90 days
    •once daily U100 or U200 insulin degludec; once daily U100 or U300 insulin glargine, once or twice daily U100 insulin detemir (Levemir), or once or twice daily human insulin Neutral Protamine Hagedorn
    •Have been treated with at least twice daily dosing of any of the following for at least 90 days. One dose of prandial insulin must occur prior to the evening meal. Lispro (U100 and U200), Lispro-aabc (U100 or U200), Aspart (U100; including Fiasp and Novolog), Glulisine (U100), Regular insulin (U100)
    •Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days:
    •dipeptidyl peptidase IV inhibitors, sodium-glucose co-transporter-2 inhibitors, biguanides (e.g., metformin), or glucagon-like peptide-1 receptor agonists.
    •Have a BMI ≤45 kg/m2
    E.4Principal exclusion criteria
    • Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D
    • Are currently receiving any of the following insulin therapies (outside of pregnancy) anytime in the past 90 days except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks: Insulin mixtures, Affreza (inhaled regular human insulin), continuous subcutaneous insulin infusion therapy, Regular insulin U500
    • Have received any of the following nonallowed diabetes medication within prior 90 days: glinides, sulfonylureas, pramlintide, alpha-glucosidase inhibitors or thiazolidinediones
    • 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 within the 6 months prior to screening
    • Have hypoglycemia unawareness in the opinion of the investigator
    • Anticipates making change in personal CGM or FGM use (e.g., initiation, stopping, changing device) during the study
    • Hepatic: Have acute or chronic hepatitis, cirrhosis, or signs or symptoms of any other liver disease, except nonalcoholic fatty liver(NAFLD), or have elevated liver enzyme measurements
    • Oncologic: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
    • Hematologic: Have had a blood transfusion or severe blood loss within 90 days prior to Visit 1, Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
    • Cardiac: Have had New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
    • Gastrointestinal: Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening. Have presence of clinically significant gastroparesis in the opinion of the investigator
    • Renal: Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate <30 mL/min/1.73 m2, as determined by the central laboratory
    • Other: Have any other serious disease or condition (for example, known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, would pose a significant risk to the study participant, or preclude the study participant from following and completing the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    E.5.2Secondary end point(s)
    1. The percentage of participants achieving HbA1c <7% at Week 26 without nocturnal hypoglycemia (<54 mg/dL [3.0 mmol/L] or severe) during treatment phase
    2. The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL [3.0
    mmol/L] or severe) during treatment
    3. Change in fasting glucose measured by SMBG from baseline
    4. Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) during CGM session
    5. Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L) during CGM session
    6. Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L) during CGM session
    7. Glucose variability measured during the CGM session
    8. Insulin dose at Week 26 (basal, bolus, total, and basal/total insulin dose ratio)
    9. Incidence and rate of composite of Level 2 and 3 hypoglycemia events during treatment period
    10. Body weight change from baseline to Week 26
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints 1,2,9 up to week 26
    Secondary Endpoints 3,8,10 at week 26
    Secondary Endpoint 4,5,6,7 measured between Week 22 and Week 26
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Germany
    India
    Italy
    Mexico
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 603
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 670
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Two safety follow up visits are scheduled with each participant to follow-up on the participant’s transition from study treatment to another non-study diabetic treatment. At the last treatment visit (Visit 23 [Week 26] or ED visit), the investigator will prescribe a non-study basal insulin for use during the safety follow-up period. The investigator, in consultation with the participant, will decide on prandial insulin therapy for use during the safety follow-up period.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-28
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