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    Summary
    EudraCT Number:2022-001485-35
    Sponsor's Protocol Code Number:LPS17007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-09-29
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-001485-35
    A.3Full title of the trial
    A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gla-300 and IDeg-100 in Insulin-Naïve People with Type 2 Diabetes Mellitus and Renal Impairment
    A.4.1Sponsor's protocol code numberLPS17007
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1272-6776
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Lead
    B.5.3 Address:
    B.5.3.1Street AddressVia San Bovio, 3, San Felice
    B.5.3.2Town/ citySegrate (Milano)
    B.5.3.3Post code20054
    B.5.3.4CountryItaly
    B.5.4Telephone number+39348 2697095
    B.5.6E-mailVitalisa.Mavilio@ppd.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 Yes
    D.2.1.1.1Trade name TOUJEO®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.4Pharmaceutical 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 number300
    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 No
    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 Tresiba
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 degludec
    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 degludec
    D.3.9.1CAS number 844439-96-9
    D.3.9.4EV Substance CodeSUB96394
    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 No
    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
    Type 2 Diabetes Mellitus and Renal Impairment
    E.1.1.1Medical condition in easily understood language
    diabetes and chronic kidney disease
    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 PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate non-inferiority (with a margin of 0.3%) and, if achieved, to demonstrate the superiority in the efficacy of Gla-300 compared with IDeg-100 in terms of change in HbA1c from baseline to Week 24 in insulin-naïve patients with T2DM and renal impairment who have glycemic levels above target with oral antidiabetic drugs (OADs) with or without glucagon-like peptide 1 receptor agonist (GLP-1 RA)
    E.2.2Secondary objectives of the trial
    To evaluate the effects of treatment with Gla-300 compared with IDeg-100 on clinical parameters.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Continuous glucose monitoring (CGM) sub-study. The CGM sub-study (applicable only to North American sites) will run concurrently with the main trial, and patients eligible for the CGM sub-study will have 2 additional site visits at Week 14 and Week 22.

    A sub-study will be conducted to evaluate the effects of treatment with Gla-300 compared with IDeg-100 on metrics derived from blinded continuous glucose monitoring (CGM) at Week 12 and Week 24 in patients with T2DM and renal impairment.
    E.3Principal inclusion criteria
    Each patient must meet all of the following criteria to be enrolled in this trial:
    1. Is an adult aged ≥18 years at screening.
    2. Was diagnosed with T2DM of >1-year duration and had glycemic levels above target with OADs with or without GLP-1 RA (oral or injectable) at stable doses for ≥3 months before the screening period.
    3. Has an HbA1c ≥7.5% and ≤10.5% at screening.
    4. Has renal impairment, as defined by an eGFR of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation; National Kidney Foundation 2022).
    5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
    6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
    7. Is capable of understanding the written informed consent, and provides signed written informed consent.
    8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
    9. Is willing and able to fast without having administered study drug for scheduled site visits. (Note: Fasting is defined as no intake of food or drink, except water, in the 8 hours before blood sampling.)

    Specific to the CGM Substudy
    10. Is willing and able to wear the CGM device continuously for 14 days to capture measures for baseline CGM assessment (from Week –2 to Week 0) and again for two 14-day intervals during the
    treatment period (ie, from Week 12 to Week 14 and from Week 22 to Week 24).
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will be excluded from the trial:
    1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
    2. Has a body mass index (BMI)* >45 kg/m² during the screening period.
    *Body weight and height will be recorded during the screening period for the calculation of BMI (BMI = weight [kg]/[height (m)]2).
    3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [eg, blurred vision, difficulty speaking, feeling faint,
    difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels).
    4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening.
    5. Has been exposed to other investigational drug(s) within 1 month
    or
    5 half-lives from screening, whichever is longer.

    Specific to the CGM Substudy
    6. Uses substances known to interfere with CGM readings, such as aspirin-containing products (>650 mg/day of acetylsalicylic acid) or supplements containing vitamin C (>1000 mg/day of ascorbic
    acid) taken during the 14-day periods of baseline CGM assessment (ie, from Week –2 to Week 0) and the treatment period (ie, from Week 12 to Week 14 and from Week 22 to Week 24).
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c: Change from baseline to Week 24 (Gla-300 vs IDeg-100)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to Week 24
    E.5.2Secondary end point(s)
    • Fasting plasma glucose (FPG): Change from baseline to Week 24
    • Fasting SMPG: Change from baseline to Week 24
    • 7-point SMPG profiles: Change from baseline to Week 24, per time point within 24-hour period
    • Percentage (%) of patients reaching HbA1c target of <7.0% at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    from baseline to Week 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    United States
    Serbia
    Czechia
    Hungary
    Poland
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 251
    F.4.2.2In the whole clinical trial 630
    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)
    None
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-30
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