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    Summary
    EudraCT Number:2004-004559-21
    Sponsor's Protocol Code Number:CLAF237A2308
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-004559-21
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Long-Term Effect of Treatment with LAF237 50 mg bid to Glimepiride up to 6 mg Daily as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy
    A.4.1Sponsor's protocol code numberCLAF237A2308
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 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 nameLAF237
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVildagliptin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 nameGlimepiride
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlimepiride
    D.3.9.1CAS number 93479-97-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type II Diabetes
    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
    To demonstrate the long term efficacy of add-on therapy with LAF237 in patients
    with type 2 diabetes inadequately controlled with prior metformin monotherapy by
    testing the hypothesis that the HbA1c reduction with LAF237 is at least non-inferior
    to that with glimepiride at the Week 104 endpoint.
    E.2.2Secondary objectives of the trial
    1. To demonstrate the safety of LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by showing that add-on therapy with LAF237 has a favorable adverse event profile, including the frequency and severity of hypoglycemia, compared to glimepiride over the duration of the study.
    2. To demonstrate the efficacy of add-on therapy with LAF237 in patients with type 2
    diabetes inadequately controlled with prior metformin monotherapy by testing the
    hypothesis that the fasting plasma glucose (FPG) reduction with LAF237 is noninferior
    to that with glimepiride at Week 104 endpoint.
    3. To demonstrate the ancillary clinical benefits of add-on therapy with LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that LAF237 has a favorable effect on body weight relative to glimepiride at Week 104 endpoint.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male, non-fertile female (i.e. post menopausal, post hysterectomy, or sterilized by tubal ligation) or female of childbearing potential using a medically approved birth control method (e.g. hormonal contraceptives, IUD, double-barrier contraception). A female of childbearing potential using a medically approved birth control method must be willing to use the same method of contraception during the full course of the study.
    2. Patients with type 2 diabetes who have received metformin for at least three months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1.
    3. Agreement to maintain the same dose of metformin throughout the study.
    4. Age in the range of 18-73 years inclusive.
    5. Body mass index (BMI) in the range of 22-45 kg/m2 inclusive at Visit 1.
    6. HbA1c of > 6.5% and ≤ 8.5% at Visit 1.
    7. Intent to maintain prior diet and exercise habits during the full course of the study.
    8. Written informed consent to participate in the study.
    9. Ability to comply with all study requirements.
    E.4Principal exclusion criteria
    1. Pregnant or lactating female.
    2. Diagnosis of or a history of:
    • type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly.
    • acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
    3. Evidence of significant diabetic complications, e.g. symptomatic autonomic neuropathy or gastroparesis.
    4. Acute infections which may affect blood glucose control within 4 weeks prior to Visit 1.
    5. A history of:
    • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
    • percutaneous coronary intervention within the past 3 months.
    • any of the following within the past 6 months: myocardial infarction (MI) (if the Visit 1 electrocardiogram (ECG) reveals patterns consistent with an MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor); coronary artery bypass surgery; unstable angina; or stroke.
    6. Congestive heart failure (CHF) requiring pharmacologic treatment.
    7. Any of the following ECG abnormalities:
    • second degree atrioventricular (AV) block (Mobitz 1 and 2)
    • third degree AV block
    • prolonged QTc (> 500 ms)
    8. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
    9. Liver disease such as cirrhosis or chronic active hepatitis.
    10. Renal disease or significant renal dysfunction.
    11. Treatment with growth hormone or similar drugs.
    12. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
    13. Donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
    14. Contraindications and warnings according to the country specific label for metformin or glimepiride not listed in the other exclusion criteria.
    15. Known sensitivity to glimepiride or other sulfur containing drugs.
    16. Treatment with any oral anti-diabetic other than metformin within 3 months prior to Visit 1.
    17. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months.
    18. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to Visit 1.
    19. Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
    20. Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the thyroid stimulating hormone (TSH) is within normal limits at Visit 1.
    21. Investigational drug treatment within 4 weeks prior to Visit 1 unless local health authority guidelines mandate a longer period.
    22. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e. cytostatic drugs).
    23. Any of the following laboratory abnormalities:
    • ALT, AST greater than three times the upper limit of the normal range at Visit 1.
    • Direct bilirubin greater than 1.3 times the upper limit of the normal range at Visit 1.
    • Serum creatinine levels ≥ 132 micromol/L (1.5 mg/dL) males, ≥ 123 micromol/L (1.4 mg/dL) females at Visit 1.
    • Clinically significant TSH outside of normal range at Visit 1.
    • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia and glycosuria at Visit 1.
    • Fasting triglycerides > 7.9 mmol/L (> 700 mg/dL) at Visit 1.
    • Positive glutamic acid decarboxylase (GAD) antibodies at Visit 1 (GAD antibodies will be tested in patients < 30 years of age).
    24. History of active substance abuse (including alcohol) within the past 2 years.
    25. Potentially unreliable patients and those judged by the investigator to be unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c measured by ion exchange High Performance Liquid Chromatography (HPLC).
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    Double dummy, Add-on therapy
    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.8.5The trial involves multiple Member States Yes
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state80
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3000
    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 Decision2005-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-18
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