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    Summary
    EudraCT Number:2009-010913-59
    Sponsor's Protocol Code Number:LANTU_L_04079
    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:2009-04-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010913-59
    A.3Full title of the trial
    Health Assessment, Patient treatment satisfaction and Quality-of-Life in insulin-naive type 2 diabetes Patients uncontrolled on OHA treatment initiating basal insulin therapy with either insulin glargine or NPH insulin added to therapies with oral hypoglycemic agents. A multicenter, prospective, crossover, open randomized clinical phase-IV trial.
    A.3.2Name or abbreviated title of the trial where available
    HAPPY
    A.4.1Sponsor's protocol code numberLANTU_L_04079
    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 Deutschland GmbH
    B.1.3.4CountryGermany
    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 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
    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.3.2Product code HOE 901
    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.3.9.2Current sponsor codeHOE901
    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) 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 Yes
    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 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 Insuman Basal
    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 nameHuman insulin
    D.3.4Pharmaceutical form Suspension 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 human
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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) 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 Yes
    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
    Diabetes mellitus type 2
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the impact of insulin glargine vs. NPH basal insulin on a composite diabetes related quality of life score (DRQoL), consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), the Problem Areas in Diabetes Questionnaire score (PAID) and the mental health score of the SF 12® Health Survey (SF 12®). The treatments consist of a combination therapy of oral antidiabetic agents and either insulin glargine or NPH basal insulin
    E.2.2Secondary objectives of the trial
    Comparison of combination therapy with insulin glargine vs. NPH basal insulin from baseline to endpoint in terms of:
    - Glycaemic parameters: change in HbA1c, fasting
    blood glucose, 7 point glucose profile, total daily
    insulin dose at endpoints
    - Incidence of confirmed symptomatic hypoglycemia
    (ADA criteria) as well as confirmed severe
    hypoglycemia (third party assistance, according to
    ADA criteria)
    - Change in lipid status (total cholesterol, HDL, LDL,
    triglycerides), change in body weight
    - Health Assessment, Patient treatment satisfaction and
    Quality-of-Life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written Informed Consent must be obtained for all patients before commencement in the study at visit 1 (Appendix A: Informed Consent document). Subjects meeting all of the following inclusion criteria will be considered for enrollment into the study:
    1. Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria (24)
    2. Treatment with one or maximum two oral antihyperglycemic agents on a stable dosage during at least at the last 4 weeks from the following substances/substance classes: metformin, sulfonylurea, DPP-IV inhibitors.
    3. No pre-treatment with any insulin in the last 3 months before the study.
    4. HbA1c value between ≥ 7.0% and ≤ 10.0%.
    5. FBG ≥ 120 mg/dl (6.7 mmol/l).
    6. Men and women aged between 18-80 years inclusive.
    7. Body mass index > 22 kg/m²and <40 kg/m².
    8. Ability to read and understand German language.
    9. Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
    10. Women of childbearing potential who will take adequate contraceptive protection such as systemic hormones (birth control pills, implant), intrauterine device (IUD), a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom), or whose partner is sterilized or who perform sexual abstinence.
    E.4Principal exclusion criteria
    1. Patients with type 1 diabetes mellitus.
    2. Any history of ketoacidosis
    3. Pregnancy (as determined by pregnancy serum test at visit 1).
    4. Prior treatment with insulin within the last 3 months before the study
    5. Treatment with more than two oral agents within the last 4 weeks or continuous treatment with thiazolidinediones or GLP-1 receptor agonists.
    6. History of drug or alcohol abuse.
    7. Diabetic retinoathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
    8. Following pancreatectomy.
    9. Impaired hepatic function, as shown by, but not limited to, SGPT (ALAT) or SGOT (ASAT), above 2x the upper limit of normal measured at visit 1.
    10. Impaired renal function, as shown by, but not limited to, serum creatinine > 177 µmol/l (> 2.0 mg/dl) measured at visit 1.
    11. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
    12. Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
    13. Inability to attend the visits according to the study schedule.
    14. Absence of adequate contraception
    15. Current treatment because of a psychiatric disease.
    16. Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
    17. Systemic corticoids > 7,5 mg prednisolon equivalent or ≤ 7,5 mg prednisolon equivalent for less than 2 months.
    18. Current participation in other clinical studies or participation in a clinical study during the last 3 months prior to participation in this study.
    19. Patient underwent bariatric surgery for weight reduction (e.g. gastric banding)
    20. Patient undertook major dietary changes for weight management during the last 3 months prior to participation in this study, resulting in weight reduction of at least 5kg

    E.5 End points
    E.5.1Primary end point(s)
    Health Assessment, Patient treatment satisfaction and Quality-of-Life
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient Reported Outcomes
    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 No
    E.8.1.6Cross over Yes
    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.8.3 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 concerned37
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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 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 state332
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 332
    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 Decision2009-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-16
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