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    Summary
    EudraCT Number:2007-003723-21
    Sponsor's Protocol Code Number:CLAF237A23137
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003723-21
    A.3Full title of the trial
    A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with type 2 diabetes and moderate renal insufficiency
    A.4.1Sponsor's protocol code numberCLAF237A23137
    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 namevildagliptin
    D.3.2Product code LAF237
    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 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 namevildagliptin
    D.3.2Product code LAF237
    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 number100
    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 placeboTablet
    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
    Diabetes Type 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 safety and tolerability of vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with T2DM and moderate renal insufficiency over 24 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Exploratory objective(s)
    • To explore the relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin (50 mg qd and 100 mg qd) in patients with T2DM and moderate renal insufficiency.
    • To explore the efficacy of vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with T2DM and moderate renal insufficiency by assessing the hemoglobin A1C (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline after 24 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age in the range of 18-85 years inclusive at visit 1
    2. Patients with T2DM either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to visit 1) or treated with anti-diabetic therapy defined as sulfonylurea, AGIs, TZDs, insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1
    3. Patients treated with anti-diabetic therapy must be on a stable dose for the past 4 weeks prior to visit 1 (stable insulin therapy is defined as ± 20% of total daily units)
    4. GFR estimated by the Cockcroft-Gault formula of ≥ 30 and < 50 mL/min at visit 1
    5. HbA1c of ≥ 6.5 and ≤ 10 % at visit 1
    6. Body weight < 120 kg and body mass index (BMI) 18-42 kg/m2 at visit 1
    7. Male, non-fertile female or female of childbearing potential using a medically approved birth control method by the country health authorities that may include:
    • A non-fertile female is defined as : post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mLU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation
    • A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means
    • Medically approved birth control methods may include: hormonal contraceptives, intrauterine contraceptive device (IUD), and double-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Reliable contraception should be maintained throughout the study
    8. Agreement to continue their current diet/exercise regimen and sulfonylurea, AGI, TZD, insulin, or metiglinide therapy throughout the duration of the study or to remain untreated if patient is not taking anti-diabetic therapy, unless otherwise instructed by the trial’s physician
    9. Written informed consent to participate in the study and ability to comply with all study requirements
    E.4Principal exclusion criteria
    1. FPG ≥ 270 mg/dL (≥15 mmol/L)
    2. Pregnant or lactating female
    3. 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
    4. Patients that have been enrolled in a vildagliptin clinical trial or other
    DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within six months prior to visit 1
    5. History of renal transplant at any time in the past
    6. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
    7. Any pre-existing lower extremity diabetic skin ulcer
    8. Patients taking TZDs with established peripheral edema
    9. Congestive heart failure (New York Heart Association (NYHA) class III-IV)
    10. Any of the following within the past 6 months:
    • myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the clinical trial at the discretion of the investigator and/or local medical monitor);
    • unstable angina
    • coronary artery bypass surgery or percutaneous coronary intervention;
    • stroke
    11. Any of the following ECG abnormalities:
    • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation
    • second degree AV block (Mobitz 1 and 2)
    • third degree AV block
    • prolonged QTc (> 500 ms)
    12. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years
    13. Liver disease such as cirrhosis or chronic active hepatitis B and C
    14. Patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis) or on the dialysis list at visit 1
    15. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
    16. Any of the following concomitant medications:
    • any anti-diabetic therapy other than sulfonylureas, AGIs, TZDs, insulin, and metiglinides within 8 weeks prior to visit 1
    • chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1
    • treatment with class Ia, Ib and Ic or III anti-arrhythmics
    • treatment with growth hormone or similar drugs
    • treatment with probenecid
    • treatment with any medication that is contraindicated in the renal impaired population (GFR < 50 mL/min: as calculated by Cockcroft-Gault formula)
    • treatment with any medication that is contraindicated in the use with sulfonylureas, AGIs, TZDs, insulin, and metiglinides
    • use of other investigational drugs within 30 days or 5 half-lives of the drug at visit 1, which ever is longer, unless local health authority guidelines mandate a longer period
    • treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e. cytostatic drugs)
    17. Any of the following significant laboratory abnormalities:
    • Clinically significant thyroid stimulating hormone (TSH) outside of normal range at visit 1
    • Clinically significant laboratory abnormalities at the opinion of the investigator
    • Patients with a serum albumin < 3.0 g/dL at visit 1
    • Patients with a hemoglobin concentration < 9 g/dL at visit 1
    • Elevated fasting triglycerides > 500 mg/dL at visit 1, confirmed by a repeat measure within 3 working days
    • Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at visit 1, confirmed by a repeat measure within 3 working days
    • Total bilirubin > 2 x ULN and/or direct bilirubin greater than the ULN at visit 1, confirmed by a repeat measure within 3 working days
    • History of spontaneous or drug induced muscle symptoms (not associated with exercise and/or physical activity), and/or elevated CPK (> 3 x ULN) confirmed by a repeat measure within 3 working days
    • A positive Hepatitis B surface test (antigen - HbsAg)
    • A positive Hepatitis C test (HCV antibodies)
    18. History of active substance abuse (including alcohol and alcohol related hepatic disease) within the past 2 years
    19. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
    20. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of safety and tolerability of vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with T2DM and moderate renal insufficiency over 24 weeks of treatment.

    The variables for the primary objectives include treatment emergent adverse events (including hypoglycemia events and events of special interest), serious adverse events. Biochemistry and hematology laboratory test results, ECG findings, and vital signs/body weight will also be assessed.
    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 Yes
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 Yes
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with mild renal impairment
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 300
    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 Decision2007-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
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