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    Summary
    EudraCT Number:2006-000324-13
    Sponsor's Protocol Code Number:LANTU-C-00579
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-07
    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 ConcernedIreland - HPRA
    A.2EudraCT number2006-000324-13
    A.3Full title of the trial
    TARGET GLYCEMIC CONTROL AND THE INCIDENCE OF DOCUMENTED SYMPTOMATIC HYPOGLYCEMIA IN INSULIN NAÏVE SUBJECTS WITH TYPE 2 DIABETES FAILING ON ORAL HYPOGLYCEMIC AGENT(S) AND TREATED
    WITH LANTUS (INSULIN GLARGINE) OR LEVEMIR (INSULIN DETEMIR): MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, COMPARATIVE, PARALLEL-GROUP STUDY
    A.3.2Name or abbreviated title of the trial where available
    L2T3
    A.4.1Sponsor's protocol code numberLANTU-C-00579
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis groupe
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 LANTUS 100IU/ml solution for injection in a cartridge
    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 nameLantus 100 IU/ml, solution for injection in a cartridge
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 100
    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) 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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 LEVEMIR 100U/ml solution for injection in a cartridge
    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 nameLevemir 100 U/ml solution for injection in a cartridge
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 detemir
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 100
    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) 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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 II diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    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 the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) inferior or equal to 56 mg/dL (3.1 mmol/L)
    E.2.2Secondary objectives of the trial
    To compare :
    • between the 2 trt groups, the % of pts who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period
    • the changes in HbA1c and FPG
    • the evolution of blood glucose profiles
    • the day to day FPG variability, the insulin doses
    • the overall incidence , rate of symptomatic hypoglyc. and nocturnal symptomatic hypoglyc.confirmed by PG < = 56 mg/dL
    • over the trt period, the overall incidence and rate of symptomatic hypoglyc. and symptomatic nocturnal hypoglyc. (with PG< =70 mg/dL , of symptomatic day-time hypoglyc. (with PG < =70 mg/dL and with PG < = 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglyc. with PG < =56 mg/dL
    • the overall safety: incidence of AE (including serious hypoglyc. and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio

    To determine the biochemical and patient-related determinants of failure to reach HbA1c targets

    To assess the QoL and trt satisfaction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women, aged from 40 to 75 years inclusive
    2. Type 2 diabetes for at least 3 years
    3. Insulin naïve
    4. Treated with stable doses of OADs for at least 3 months prior to study start, including at least metformin (at least 1g/day)
    5. 7% <= HbA1c <=10.5 %
    6. Body mass index (BMI) < 40 kg/m2
    7. Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
    8. Written informed consent obtained prior to enrollment in the study
    E.4Principal exclusion criteria
    1. Type 1 diabetes
    2. Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
    3. Treatment with thiazolidinediones, GLP-1 receptor agonists or with DPP-IV inhibitors
    4. Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
    5. Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
    6. Breast-feeding
    7. History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
    8. Treatment with systemic corticosteroids in the 3 months prior to study entry
    9. Treatment with any investigational product in the 2 months prior to study entry
    10. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
    11. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
    12. Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
    13. Impaired renal function as shown by serum creatinine >=1.5 mg/dL (>= 133 μmol/L) in men and >= 1.4 mg/dL (124 μmol/L) in women at study entry
    14. History of drug or alcohol abuse in the last year
    15. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
    16. Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
    17. Patient is the investigator or any sub-investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Data collected for the assessment of primary and main secondary endpoints:
    • HbA1c recorded at baseline, week 12 and week 24
    • Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm on the 4 consecutive days before each visit
    • Self-monitored blood glucose values from 8-point 24-hour profile (immediately before and 2 hours after breakfast, lunch and dinner, at bedtime and at 3:00 a.m.) recorded on 2 consecutive days within the week prior to randomization visit 2 (baseline), visit 12 (week 12) and last visit (week 24). In this protocol, bedtime should be at least 2 hours and 30 minutes after dinner
    • Episodes of hypoglycemia (symptomatic hypoglycemia, total and categorized as day-time/nocturnal, severe hypoglycemia, asymptomatic hypoglycemia)
    • Self-monitored blood glucose values whenever the patient experiences symptoms possibly related to hypoglycemia
    • Daily doses of insulin glargine or insulin detemir
    • Laboratory fasting plasma glucose at baseline, week 12 and week 24
    • Insulinemia and fasting C-peptide level at baseline
    • Lipid profile at baseline and week 24
    • Patient reported outcomes (quality of life and treatment satisfaction) will be assessed at baseline, week 4, week 12 and at the last visit, using: the Fear of hypoglycemia score (in the Netherlands and Germany, at baseline only), the DSC-R and the WHO-5 (in selected countries), and the DTSQ questionnaires
    • Safety data: occurrence of adverse events and weight will be assessed at each visit. Waist and hip circumferences will be measured at baseline, week 12 and week 24. Systolic and diastolic blood pressure will be measured at study entry, baseline, week 12 and week 24. A physical examination will be performed at study entry and at the last visit.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 EEA72
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 910
    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)
    No specific recommendation. Not different from the expected normal treatment
    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 Decision2006-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
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