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    Summary
    EudraCT Number:2009-011965-10
    Sponsor's Protocol Code Number:AT130-G-08-006
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-15
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-011965-10
    A.3Full title of the trial
    A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 Administered Twice Daily for 24 Weeks in Treatment-naïve, Metformin Only or Metformin plus Sulfonylurea -treated Obese Type 2 Diabetic Patients
    A.3.2Name or abbreviated title of the trial where available
    PROMOTE
    A.4.1Sponsor's protocol code numberAT130-G-08-006
    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 SponsorAkros Pharma Inc.
    B.1.3.4CountryUnited States
    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.3.2Product code JTT-130
    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.3.9.1CAS number 594842-13-4
    D.3.9.2Current sponsor codeJTT-130
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.3.2Product code JTT-130
    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.3.9.1CAS number 594842-13-4
    D.3.9.2Current sponsor codeJTT-130
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    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 11.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the change in glycosylated hemoglobin (HbA1c) levels after JTT-130 is administered twice daily for 24 weeks in obese type 2 diabetic patients compared to placebo.
    E.2.2Secondary objectives of the trial
    •To investigate the weight loss effect of JTT-130 administered twice daily for 24 weeks to obese type 2 diabetic patients compared to placebo.
    •To investigate the effect of JTT-130 administration on ancillary efficacy measures (e.g., fasting plasma glucose, plasma insulin, serum lipid parameters, waist circumference) in obese type 2 diabetic patients compared to placebo.
    •To determine the safety and tolerability of JTT-130 when administered for 24 weeks in obese type 2 diabetic patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females, 18-70 years of age (inclusive) at the screening visit (Visit 1), with a stable weight (no known weight variation of > 5% within 3 months prior to Visit 1);
    2. Able and willing to give written informed consent;
    3. Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2 at Visit 1;
    4. Have type 2 diabetes (HbA1c between 7.0% and 10.0% [inclusive]) at Visit 1;
    5. Have fasting plasma glucose (FPG) levels of ≤ 280mg/dL (15.5 mmol/L) at Visit 1 (up to one repeat measurement allowed on a different day within the screening window);
    6. Are either drug naïve with respect to hypoglycemic agents (e.g., managed with diet and exercise only) OR are currently being treated with metformin (at least 1500 mg/day) alone or in combination with a sulfonylurea (at least half the maximum labeled daily dose or at the maximum tolerated dose). For this study, drug naïve is defined as either never having taken hypoglycemic agents OR previously taken hypoglycemic agents but discontinued them at least 1 month prior to Visit 1. Metformin and sulfonylurea dosing must be stable, defined as no change in dose for at least 2 months prior to Visit 1 and no expected change during the study;
    7. Females may participate if they meet one of the following criteria:
    • Surgically sterile (e.g., hysterectomy, bilateral oophorectomy or tubal ligation)
    OR
    • Post-menopausal (i.e., lack of menses for ≥ 12 months at Visit 1 with no other identified biological/surgical cause AND a serum FSH measurement of ≥ 40 mIU/mL [40 IU/L] at Visit 1)
    OR
    • Of childbearing potential and are compliant with a contraceptive regimen. Acceptable contraception includes: oral or transdermal contraceptives, intrauterine devices, implantable or injectable contraceptives, condom with a spermicide, diaphragm, cervical cap, vaginal sponge, vaginal ring, or “female condom”. The contraceptive regimen must be maintained during the study and for at least 2 weeks after discontinuation of study drug;
    Note: Females reporting lack of menses for ≥ 12 months prior to Visit 1 that have a serum FSH < 40 mIU/mL (40 IU/L) at Visit 1 will be considered of childbearing potential and must comply with a contraceptive regimen as described above.
    8. Males with partners of childbearing potential must agree to utilize a barrier contraceptive for the duration of the study and for at least 2 weeks after discontinuation of the study drug.
    E.4Principal exclusion criteria
    The following criteria will exclude a patient from participating in the study: 1. Females who are pregnant or breast-feeding; 2. Known medical history or presence of type 1 diabetes or pancreatitis; 3. Known medical history of acute metabolic diabetic complications (such as ketoacidosis, lactic acidosis, or hyperosmolar coma) within the past 6 months prior to Visit 1; 4. Known medical history or presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy; 5. Acute coronary syndrome (e.g., myocardial infarction or unstable angina), NYHA (New York Heart Association) class III and IV heart failure, percutaneous coronary intervention (Percutaneous Transluminal Coronary Angioplasty PTCA or similar procedures), coronary artery bypass graft surgery (CABG), cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to Visit 1 or a history of severe peripheral vascular disease; 6. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg at Visit 1, up to three repeat measurements allowed); 7. A history of, or presence of, malignancy (except for treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 8. Known medical history or presence of genetic conditions that influence weight and/or glucose metabolism or indicate adrenal/HPA-axis hyperfunction/hypofunction (e.g., Addison’s or Cushing’s Disease); 9. Known medical history or presence of anorexia nervosa, bulimia nervosa or binge eating disorder; 10. Known acute or chronic gastrointestinal symptoms or conditions at Visit 1 that are considered clinically-relevant by the Investigator (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac sprue); 11. Was hospitalized for a clinically relevant condition or major intervention, according to the investigator’s medical judgment within the 6 months prior to Visit 1, had a surgical treatment for weight loss or has a scheduled hospitalization during the study period; 12. Does not meet all medication restriction criteria, as described in Appendix 1 of the protocol; 13. Known clinically relevant medical history or presence of any other conditions that would put the patient at risk, or would interfere with the study or the interpretation of the data, according to the principal investigator’s medical judgment; in general, stable conditions, with the exception of those listed as other exclusion criteria, or those that would prevent the patients to comply with the concomitant medication restrictions could be considered acceptable for study inclusion; 14. Abnormal liver and kidney functions as measured by AST, ALT, or bilirubin ≥ 2.0 x ULN and serum creatinine ≥ 1.5 mg/dL for men or ≥ 1.4 mg/dL for women at Visit 1; 15. Serum thyroid stimulating hormone (TSH) ≥ 1.5 x ULN at Visit 1; 16. Triglycerides > 500 mg/dL (5.6 mmol/L) at Visit 1; 17. Hemoglobin < 10 g/dL for males and < 9 g/dL females, or any known hemoglobinopathies or hemolytic conditions at Visit 1; 18. Have donated and/or received any blood or blood products within 1 month prior to Visit 1; 19. Any change in smoking habits (or usage of other nicotine products) within 2 months prior to Visit 1; 20. Test positive for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C (HCV) antibody at Visit 1; 21. Weight gain of > 2.0 % or poor study drug compliance (< 80% or > 120%) during the two-week single-blind placebo Run-in Period (between Visit 2 and Visit 3); 22. Cannot communicate reliably with the Investigator and are unlikely to cooperate with the requirements of the study; 23. May be hypersensitive, in the opinion of the Investigator, to any component of the JTT-130 formulation, or have a significant history of drug hypersensitivities (i.e., multiple drug allergies or severe allergic reactions).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint in this study is HbA1c reduction: change from baseline to EOT
    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 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
    Tolerability
    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 Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Protocol page 62
    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 years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 378
    F.4.2.2In the whole clinical trial 460
    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 different than 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 Decision2009-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-06
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