PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sun, 30 Dec :36:45 GMT) CTRI Number CTRI/2009/091/ [Registered on: 30/07/2009] - Last Modified On 13/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Efficacy and Safety of Alogiptin plus Metformin Compared to Glipizide plus Metformin in Subjects with Type 2 Diabetes Mellitus. A Multicenter, Randomized, Double-Blind, Active Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes.(ENDURE) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 09/H0703/ EudraCT DOH HKCTR-862 NCT SYR-322_305 U Designation Affiliation ClinicalTrials.gov Protocol Number UTN Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Shubhangi Desai Associate Director, Clinical Project Management SIRO Clinpharm Pvt. Ltd. Phone Fax Designation Affiliation SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA India shubhangi.desai@siroclinpharm.com Details Contact Person (Public Query) Dr Shubhangi Desai Head Clinical Operations - Asia Pacific SIRO Clinpharm Pvt. Ltd. page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Phone Fax > NIL Type of Sponsor NIL List of Countries Argentina Australia Canada Chile Dominican Republic Germany Guatemala Hungary India Israel Italy Latvia Lithuania Malaysia Mexico New Zealand Peru Philippines Poland Russian Federation Singapore South Africa Spain Taiwan Thailand Ukraine United Kingdom United States of America SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA India Source of Monetary or Material Support Primary Sponsor Details Takeda Global Research Development Centre Europe Ltd 61 Aldwych London WC2B 4AE United Kingdom. Pharmaceutical industry-global Sites of Study of Principal of Site Site Phone/Fax/ page 2 / 7

3 Investigator Dr Prasanna Kumar Dr Mala Dharmalingam Dr Neeta Deshpande Dr Sanjay Kalra Dr Ajay Kumar Diabetes Centre Endocrinology and Diabetes Research Center (BEDRC) Belgaum Diabetes Centre Bharti research institute of Diabetes and Endocrinology Diabetes Care & Research Center No 426, 4th Cross, 2nd Block Kalyan Nagar, KARNATAKA No. 35, 5th Cross, Malleshwaram Circle, Malleshwaram, KARNATAKA Near Mahila Bhandar, Ground floor, Maruti Galli, Belgaum Belgaum KARNATAKA Wazir Chand Colony, Kunipura Road, Karnal Karnal HARYANA GC1 B, Near Over Bridge, Kanker Baugh, Patna Patna BIHAR Dr Naga Jyothi Borra Diabetomics India /17B Hindi Nagar, Behind Panjagutta Saibaba Temple Banjara Hills PO Hyderabad Hyderabad ANDHRA PRADESH Dr Shachin Gupta Krishna Diabetes Clinic and Educational Research Centre 8/2 Sanjay Complex, South T.T. Nagar, Near Mata Mandir, Bhopal Bhopal MADHYA PRADESH Dr K D Modi Medwin Hospital Raghava Ratna Towers, Chirag Ali Lane, Hyderabad Hyderabad ANDHRA PRADESH Dr Tushar Bandgar Dr Ravindranath Research Health Institute in Diabetes, Endocrinology & Metabolism (RHIDEM) Trichy Diabetic Speciality Center 1/15, Roopal Apartment, 3rd floor, Opposite Aroma Hotel, Dadasaheb Phalke Road, Dadar, Mumbai Mumbai MAHARASHTRA Center,B 37,Shastri Road, 7th Cross,East dr.kmpk@gmail.com mala_endo@rediffmail. com neetadeshpande@hotm ail.com bhartihospital@rediffma il.com drajaykr@yahoo.com diabtrials@gmail.com shachinseema@yahoo. com drkdmodi@yahoo.co.in drtusharb@gmail.com page 3 / 7

4 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Thillai Nagar, Trichy Tiruchirappalli TAMIL NADU raviril2009@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Endocrinology and Diabetes Research Cente Ethics Committee on Human Research, Clinicom, (for site at Belgaum) Clinicom, (for site at Hyderabad) Clinicom, (for site at Mumbai) Clinicom, (for site at Trichy) Ethics Committee - Diabetes Care and Research Center, Patna Independent Ethics Committee of Krishna Diabetes Clinic and Educational Research Centre, Bhopal Institutional Ethics Committee for BRIDE, Karnal Institutional Ethics Committee, Medwin Hospitals, Hyderabad Medisys Clinisearch Ethical Review Board, Status Approved 24/04/2009 No Approved 02/05/2009 Yes Approved 23/04/2009 Yes Approved 23/04/2009 Yes Approved 20/04/2009 Yes Approved 25/04/2009 No Approved 07/04/2009 Yes Approved 22/04/2009 No Approved 26/06/2009 No Approved 08/05/2009 No Date Approved/Obtained 09/07/2009 Health Type Patients Condition Type 2 Diabetes Mellitus Type Details Intervention Alogliptin and Metformin Alogliptin 12.5 mg, tablets, orally, od, Glipizide placebo-matching tablets, orally, od and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. Intervention Alogliptin and Metformin Alogliptin 25 mg, tablets, orally, od, Glipizide placebo-matching page 4 / 7

5 Inclusion Criteria Exclusion Criteria tablets, orally, od and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. Comparator Agent Glipizide and Metformin Glipizide 5 mg, tablets, orally, od, Alogliptin placebo-matching tablets, orally, od and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. Age From Age To Gender Details Details Year(s) Year(s) Female Inclusion Criteria 1.Has a diagnosis of type 2 diabetes mellitus. 2.Must be inadequately controlled (inadequate glycemic control refers to HbA1c concentration between 7.0 and 9.0 %, inclusive)on a stable daily dose of greater than or equal to1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening or must be inadequately controlled (as defined by an HbA1c 7.5 and 10 %, inclusive) on metformin less than 1500 mg without documented maximum tolerated dose. 3.No treatment with antidiabetic agents other than metformin for 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B). 4.Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be greater than or equal to 20 kg/m2 and less than or equal to 35 kg/m2, inclusive. 5.Has fasting C-peptide concentration at least 0.8 ng/ ml. 6.If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to screening/ pre-screening. 7.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study. 8.Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments. Exclusion Criteria 1.Systolic blood pressure greater than or equals to 150 mmhg and/or diastolic pressure greater than or equals to 90 mmhg at screening visit. 2.Hemoglobin less than/equal to 12 g/dl for males and less than/equal to 10 g/dl for females at screening visit. 3.Alanine aminotransferase greater than 2.5 times the upper limit of normal at Screening Visit. 4.Serum creatinine less than or equal to 1.5 mg/dl for males and less than or equal to 1.4 mg/dl for females, or calculated creatinine clearance less than 60 L/min. 5.A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs prior to screening. 6.A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to screening. 7.Treated for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 8.New York Heart Association Class III or IV heart failure regardless page 5 / 7

6 Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Centralized of therapy. 9.History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening. 10.History of any hemoglobinopathy that may affect determination of HbA1c. 11.Known history of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or Hepatitis C virus (HCV). 12.History of psychiatric disorder that will affect the subject?s ability to participate in the study. 13.Alcohol or substance abuse within 2 years prior to screening. 14.Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: 15.Any investigational drug within 30 days prior to screening. 16.Any investigational diabetic drug within 3 months prior to screening. 17.Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening. 18.Subject is a study site employee or is an immediate family member of a study site employee who is involved in the study. 19.Prior treatment with alogliptin. 20.Treatment with Weight-loss drugs, or oral or systemically injected glucocorticoids (including intra-articular injection) within 3 months prior to randomization through the completion of the end-of-treatment/ early termination procedures. 21.Received an investigational antidiabetic drug within the 3 months prior to screening. 22.Has a history of hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide. 23.Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules). Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Change from baseline in Glycosylated Hemoglobin Week 52 or week 104 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First 20/09/2009 Change from baseline in Glycosylated Hemoglobin Change from baseline in Fasting Plasma Glucose Incidence of Glycosylated Hemoglobin less than or equal to 6.5% Incidence of Glycosylated Hemoglobin less than to 7.0% Weeks 4,8,12,16,20,26,39,65,78 and 91 Weeks 2,4, 8,12, 16,20,26, 39, 52, 65, 78, 91 and 104 Weeks 26, 52, 78 and 104 Weeks 26, 52, 78 and 104 Change from Baseline in Body Weight Weeks 12, 26, 39, 52, 65, 78, 91 and 104 Total Sample Size=2445 Sample Size from India=400 page 6 / 7

7 Powered by TCPDF ( PDF of Trial Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary 06/04/2009 Years=2 Months=0 Days=0 Completed Completed Background: For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line therapy in addition to diet control and exercise. For those patients with inadequate glycemic control with metformin monotherapy or experiencing serious side effects of metformin, sulfonylurea is a popular choice as a second-line oral antidiabetic treatment. Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Study Design: This study is designed to further explore the durability of efficacy and safety of alogliptin compared to glipizide in type 2 diabetes mellitus subjects whose blood level is inadequately controlled with metformin therapy. The study will be conducted at 10 centers across India. page 7 / 7