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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-003575-47
    Sponsor's Protocol Code Number:BP21572
    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:2008-10-03
    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 number2008-003575-47
    A.3Full title of the trial
    A randomized, double-blind, placebo controlled, parallel group study to investigate the effect of Taspoglutide on gastric emptying measured by a paracetamol test after single dose and after multiple doses in patients with Type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    Gastric Emptying Study
    A.4.1Sponsor's protocol code numberBP21572
    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 SponsorF. Hoffmann-La Roche Ltd
    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 nameTaspoglutide
    D.3.2Product code RO5073031
    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 INNTaspoglutide
    D.3.9.1CAS number 275371-94-3
    D.3.9.2Current sponsor codeRO5073031/F04-04
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTaspoglutide
    D.3.9.1CAS number 275371-94-3
    D.3.9.2Current sponsor codeRO5073031/F04-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Type 2 diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term 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 effect of taspoglutide on gastric emptying (as assessed by the pharmacokinetics of paracetamol) after first and multiple dose of taspoglutide.
    E.2.2Secondary objectives of the trial
    – To explore the relationship between plasma taspoglutide concentrations and gastric emptying (as measured by the pharmacokinetics of paracetamol).
    – To assess the safety and tolerability of taspoglutide and placebo (diluent).
    – To assess the effect of taspoglutide on renal function parameters after single and multiple dose of taspoglutide.
    – To assess the multiple dose pharmacokinetics of taspoglutide.
    – To assess the effect of taspoglutide on fasting plasma glucose and HbA1c.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or Female subject, 18 through 75 years of age, inclusive.
    2. Type 2 diabetes mellitus patient.
    • Fasting plasma glucose ≤ 240 mg/dL (13.3 mmol/L) at screening.
    • HbA1c ≤ 9.5% at screening.
    •Patients treated with acceptable (not excluded) stable oral antidiabetic drug therapy for at least 3 months prior to screening
    3. Subject must have a Body Mass Index (BMI) > 25 kg/ m2 and ≤ 45 kg/m2 at screening.
    4. Stable weight ± 10% for at least 3 months before screening.
    5. Female subject must be either postmenopausal (at least one year after the cessation of menses and confirmed by FSH > 50 UI/L or postmenopausal for more than 1 year (2 years after the cessation of menses)) or surgically sterilized (by means of hysterectomy, bilateral oophorectomies or tubal ligations) or if of childbearing potential use two medically approved birth control methods (e.g. hormonal contraceptives, IUD, barrier contraception) and be willing to use the same method of contraception during the whole course of the study and for at least 3 months after the last dose.
    6. Patients able to participate and to comply with the study restrictions and have given written informed consent.
    E.4Principal exclusion criteria
    1. Type 1 diabetes mellitus.
    2. Acute gastrointestinal symptoms at the time of screening and/or Day -1 (e.g. nausea, vomiting, diarrhea, heartburn).
    3. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases (except autonomic and/ or sensomotoric neuropathy) inclusive history of chronic pancreatitis or idiopathic acute pancreatitis.
    4. Serious illness, such as active cancer, major active infection or known inflammatory process, severe psychiatric disorders at the time of the screening examination.
    5. Clinically significant GI disease including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia or surgery of the gastrointestinal tract (except appendectomy/cholecystectomy) and history of gastric bypass or antrectomy or small bowel resection.
    6. History of ketoacidosis or lactic acidosis.
    7. History of unstable hypertension (SBP > 170 mmHg and/or DBP > 105 mmHg), within the past 12 weeks prior to screening.
    8. Known proliferative diabetic retinopathy.
    9. Known hemoglobinopathy or chronic anemias.
    10. Renal disease or renal dysfunction (as suggested by serum creatinine ≥ 132 µmol/L (1.5 mg/dL) males, ≥ 123 µmol/L (1.4 mg/dL) females at screening.
    11. Clinically relevant QTc prolongation (e.g. QTc > 450 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone).
    12. Any clinically relevant abnormal laboratory test results or ECG (including positive test results for drugs of abuse and alcohol test) prior to first dosing, which precludes safe involvement in the study as judged by the investigator.
    13. Impaired liver function (ALT or AST > 3 x ULN) at screening.
    14. Subjects who test positive for HIV I and II, Hepatitis B or Hepatitis C.
    15. Pregnant or lactating women.
    16. History of active substance abuse (including alcohol) within the past 2 years.
    17. Alcohol consumption of more than 21 or 18 units (1 unit = 10 mL of pure alcohol [UK unit]) per week for males and females respectively, or a history of alcoholism.
    18. Smoking of more than 15 cigarettes a day or the equivalent amount of tobacco.
    19. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past.
    20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
    21. Current sulfonylurea antidiabetics, acarbose, DPPIV-inhibitors.
    22. Treatment with any additional oral anti-diabetic medication apart from the stable therapy (see inclusion criteria 2) and/or herbal/over the counter preparations that may affect glycemic control within 12 weeks prior to screening.
    23. Treatment with insulin for more than one week within 6 months prior to screening.
    24. Subjects who use drugs (including herbal drugs) known to affect gastrointestinal motility within two weeks before the first drug administration (e.g. prokinetics such as domperidone and metoclopramide, anticholinergics such as scopolamine etc.)
    25. Corticosteroid treatment (>7 consecutive days of treatment) within 4 weeks prior to screening.
    26. Treatment with thyroid hormones within which are not on a stable dose for at least 12 weeks prior to screening.
    27. Known hypersensitivity to taspoglutide or any of the components of its formulation.
    28. Participation in an investigational drug study within 60 days (or five half-lives, whichever is longer) prior to screening.
    29. Blood loss or donation of more than 500 mL in the 3 months prior to screening.
    30. Vulnerable subjects (e.g. persons kept in detention)
    E.5 End points
    E.5.1Primary end point(s)
    Tmax, log(AUC0-∞) and log(Cmax) of paracetamol
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    renal function, BSR (biomarker sample repository)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years
    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 Yes
    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 2008-10-03. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2008-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-27
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