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    The EU Clinical Trials Register currently displays   39361   clinical trials with a EudraCT protocol, of which   6446   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-001186-46
    Sponsor's Protocol Code Number:GLARGL07699
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-31
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001186-46
    A.3Full title of the trial
    A 28-week, prospective, single-arm, open label phase 4 study to evaluate treatment optimization with once-daily insulin glargine HOE901-300 IU/ml in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 28-week trial to determine treatment optimization with once-daily TOUJEO in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy
    A.3.2Name or abbreviated title of the trial where available
    OPTIMIZE
    A.4.1Sponsor's protocol code numberGLARGL07699
    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 Belgium
    B.1.3.4CountryBelgium
    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 Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Belgium
    B.5.2Functional name of contact pointBrigitte De Witte
    B.5.3 Address:
    B.5.3.1Street AddressAirport Plaza -Montreal Building, L. Da Vincilaan 19
    B.5.3.2Town/ cityDiegem
    B.5.3.3Post code1831
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 (0)2 710 54 00
    B.5.5Fax number+32(0)2 710 56 99
    B.5.6E-mailCTA.Belgium@sanofi.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.2.5The 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 HOE901 - U300
    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.3.9.2Current sponsor codeHOE901 - U300
    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.2.5The 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 1 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes mellitus
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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 evaluate the efficacy of optimizing treatment from BID basal to OD insulin glargine HOE901-300 IU/mL as part of basal bolus regime in terms of improving HbA1c by at least 0.3% in uncontrolled type 1 diabetes mellitus patients.
    E.2.2Secondary objectives of the trial
    • To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes and adverse events
    • To evaluate the effect of Insulin glargine HOE901-300 IU/ml on diabetes treatment satisfaction and fear of hypoglycemia as well as patient’s satisfaction regarding the number of daily injections
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or Female
    • Age ≥ 18 years
    • With Type 1 diabetes mellitus
    • Being treated BID with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year
    • Have an HbA1c measurement of 8.0% – 10.0% at study entry
    • Patients who have signed an Informed Consent Form
    E.4Principal exclusion criteria
    • Type 2 diabetes mellitus
    • Known hypoglycaemia unawareness
    • Repeated episodes of severe hypoglycemia or DKA within the last 12 months
    • End-stage renal failure or being on hemodialysis
    • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study
    • Known hypersensitivity / intolerance to insulin glargine or any of its excipients
    • Patients treated with GLP-1 receptor agonists
    • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening
    • Pregnant or lactating women
    • Women of childbearing potential with no effective contraceptive method
    • Participation in another clinical trial
    • Patient who withdraws consent during the screening or run-in phase (patient who is not willing to continue or fails to return)
    • Patients who cannot demonstrate the proper use of injection pens, diary or glucose meter before receiving the first injection of Insulin glargine HOE901-300 IU/ml
    E.5 End points
    E.5.1Primary end point(s)
    Mean HbA1c change
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 24
    E.5.2Secondary end point(s)
    • Mean HbA1c change from baseline to Week 12
    • Mean change in FPG from baseline to Week 12 and Week 24
    • Mean change in fasting SMBG from baseline to Week 4, Week 8, Week 12 and Week 24
    • Mean change in 8-point SMBG from baseline to Week 12 and Week 24
    • Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24
    • Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24 without hypoglycemia during the last 4 weeks of treatment
    • Mean change in body weight from baseline to Week 12 and Week 24
    • Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
    • Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented ≤ 70 mg/dL or 3.9 mmol/L) and/or severe hypoglycemia (nocturnal defined as time between 00:00 and 05:59 am) during the last 4 weeks of treatment
    • Number and proportion of patients experiencing hypoglycemia and number of hypoglycemic events per patient-year during the run-in period, the first 8 weeks of Insulin glargine HOE901-300 IU/ml treatment period, during the whole Insulin glargine HOE901-300 IU/ml treatment period, and during the last 4 weeks of the study. Hypoglycemic events will be recorded
    o According to definitions (severe, confirmed ≤70mg/dL and <54mg/dL, and/or severe, confirmed ≤70mg/dL and <54mg/dL)
    o And according to the time (nocturnal defined as time between 00.00 and 05:59 am, and at any time of the day)
    • Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
    • Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
    • Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
    • Frequency of AEs/SAEs
    • Change in DTSQs from screening to baseline, from baseline to Week 12 and 24, and from Week 12 to Week 24
    • Mean change from screening to baseline, baseline to Week 12 and Week 24, and Week 12 to Week 24 on the DTSQ total treatment satisfaction, hyperglycemia perception, and hypoglycemia perception scales
    • Mean change from baseline to Week 24 on the Adult Low Blood Sugar Survey (Hypoglycemia Fear Scale; HFS-II) Behavior, Worry, and Total scores
    • Patient’s satisfaction with the number of injections per day, and importance for the patient of decreasing the number of basal insulin injections assessed on a 7 point Likert scale (6=very satisfied; 0=very dissatisfied)

    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Month 6
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective single-arm study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned18
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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
    Canada
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 90
    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)
    A 3-month extension has been foreseen to cover the gap between the end of the study of the first patients and the marketing of the product.
    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 Decision2015-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-10
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