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    Summary
    EudraCT Number:2009-016382-29
    Sponsor's Protocol Code Number:P1736-05/34/09
    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:2009-11-04
    Trial 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 number2009-016382-29
    A.3Full title of the trial
    A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus
    A.3.2Name or abbreviated title of the trial where available
    P1736-05 POC study
    A.4.1Sponsor's protocol code numberP1736-05/34/09
    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 SponsorPiramal Life Sciences Limited
    B.1.3.4CountryIndia
    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 nameP1736-05
    D.3.2Product code P1736-05
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 placeboOral suspension
    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 mellitus, type 2 (Blood Glucose Lowering Effect)
    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 evaluate the changes in fasting plasma glucose versus baseline, following 12 weeks of oral dosing with P1736-05 versus placebo in adult subjects diagnosed with type 2 diabetes mellitus
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of P1736-05 versus placebo. To evaluate the pharmacokinetics of P1736-05 in type 2 diabetes mellitus subjects. To evaluate the effect of P1736-05, versus placebo, on glycemic and metabolic parameters following 12 weeks of treatment in adult subjects with type 2 Diabetes mellitus: Change in fasting plasma insulin levels Change in HbA1c Change in serum fructosamine Percent change in body weight Percent change in lipids (total cholesterol, HDL, LDL, triglycerides, VLDL, FFA) in fasting state Change in standard meal tolerance test variables including peak and 4 hour post prandial glucose, peak abd 4 hour post prandial insulin, glucose, insulin and C-peptide AUC's Change in Adiponectin and leptin levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age : 18- 65 yrs, inclusive 2. BMI : 25 - 40 kg/m2, inclusive 3. HbA1c: at screening between 7 and 10% for subjects on diet and exercise 4. FPG : at randomization ≤12.5 mmol/l 5. Fasting C-peptide: at screening ≥0.16nmol/L (>0.5ng/ml) 6. For females: negative pregnancy test at screening and each admission, or of no childbearing potential (females) (a prerequisite for female subjects of childbearing potential is adequate contraception during the study and until 3 months after the follow-up visit) Postmenopausal females: postmenopausal usually based on history of amenorrhoea duration (no menstrual period for 24 consecutive months) 7. Has an established clinical diagnosis of stable type 2 diabetes mellitus for at least 3 months prior to the screening period; (Type 2 Diabetes Mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization (WHO) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2006] 8. Drug naive (Defined as subjects not received any pharmacological treatment for at least 12 weeks before screening and no anti diabetic agents for > 3 consecutive months any time in the past). 9. Is on a stable weight, with no more than a 4% gain or loss in the 3 months prior to screening (by history).
    E.4Principal exclusion criteria
    1. MODY (Mature Onset Diabetes of the Young), insulin dependent type 2 diabetes mellitus, or other unusual or rare forms of diabetes mellitus 2. Has had >4 episodes of severe hypoglycemia that required the assistance of another person within the past 6 months (brittle diabetes) 3. Type 2 Diabetes of more than 15 years duration prior to screening. 4. Has a history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar nonketotic coma 5. Has used insulin previously within past 3 months prior to screening 6. Has used GLP-1 analog (for example, exenatide) within 6 months prior to screening 7. Has used Thiazolidinediones or DPP4 inhibitors within 6 months prior to screening. 8. Has received any investigational drug within 60 days prior to study entry 9. Has a history of hypersensitivity or allergies to similar class of drug as the study drug, unless approved by the Investigator 10. Has a clinically significant history of substance or alcohol abuse within the past year or a current diagnosis of substance or alcohol abuse 11. Has a positive serology for an infectious disease (including HIV, Hepatitis B or C) at Screening 12. Has donated blood (≥500mL) within the three months preceding the screening period or suffered significant blood loss equal to a donor portion (approx 500mL). 13. Has history of clinically significant disease other than type 2 diabetes (endocrine, hepatic, renal, Metabolic, neurological, psychiatric, cardiovascular, pulmonary, gastrointestinal, Hematological or gynecological disease (including subjects with diabetic end organ Disease (renal, cardiac, and retinal) o Subjects with significant renal insufficiency, only one functioning kidney, history of renal transplantation, or currently receiving renal dialysis o Subjects with creatinine clearance <60 mL/min as determined by Cockcroft and Gault formula o Subjects with Serum creatinine ≥1.5 mg/dL or ≥132.6 µmol/L o Subjects with a clinically significant abnormal WBC count, thrombocytopenia, or anemia at screening o Subjects with history or presence of proliferate retinopathy, macular degeneration or edema, retinal detachment, and/or severe vision impairment (i.e. subject requires assistance in daily tasks) o Subjects with hepatic disease or clinically relevant evidence of it (i.e. values at screening and at pre-randomization of more than 2 x ULN for aspartate aminotransferase [AST], alanine aminotransferase [ALT] or values of more than 1.5 x ULN for bilirubin or alkaline phosphates. Subjects with high bilirubin associated with Gilbert’s syndrome will not be excluded o Subjects who have a history of malignancy o Subjects with cardiovascular disease within the previous 6 months prior to screening (including, but not limited to, myocardial infarction, stroke, peripheral vascular disease, ischemic changes resting ECG) o Subjects with severe and uncontrolled hypertension (blood presure above 160/100) o Subjects with a history of unhealed diabetic ulcer o Subjects with hypo or hyperthyroidism 14. Subjects who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression. 15. Subjects with any other clinically significant laboratory abnormality at screening 16. Has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study. 17. Subjects who have received in the 3 months prior to screening, any systemic glucocorticoid treatment
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the changes in fasting plasma glucose versus baseline To evaluate the effect of P1736-05, versus placebo, on glycemic and metabolic parameters following 12 weeks of treatment in adult subjects with type 2 Diabetes Mellitus: • Change in fasting plasma insulin levels • Change in HbA1c • Change in serum fructosamine • Percent change in body weight • Percent change in lipids (total cholesterol, HDL, LDL, triglycerides, VLDL, FFA) in fasting state • Change in Standard Meal Tolerance Test variables including peak and 4 hour post prandial glucose, peak and 4 hour post prandial insulin; glucose, insulin and C- peptide AUC’s • Change in Adiponectin and leptin levels AEs, vital signs, ECG parameters Physical examination clinical laboratory
    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 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) 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 EEA4
    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
    Planned study period: Q4 2009 – Q3 2010
    Study will be closed for enrolling after the enrollment of 20th patient. The last visit of the last patient will be 15 weeks later (+3 days window period) this date, according with the protocol.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Not applicable
    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 Decision2010-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-10
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