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Clinical Trial Details (PDF Generation Date :- Fri, 10 May 2019 12:48:58 GMT) CTRI Number
CTRI/2015/08/006139 [Registered on: 27/08/2015] - Trial Registered Prospectively
Last Modified On
29/11/2018
Post Graduate Thesis No Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
Scientific Title of Study
A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 Diabetic Patients Inadequately Controlled on Oral Anti-diabetic Therapy
Secondary IDs if Any
Secondary ID
Identifier
2014-003708-62
EudraCT
BIASP-4157 Version 1.0 dated 18 Dec 2014
Protocol Number
U1111-1158-7280
UTN
Details of Principal Investigator or overall Name Trial Coordinator Designation (multi-center study) Affiliation
Details of Principal Investigator
Address
Phone Fax Email Details Contact Person (Scientific Query)
Details Contact Person (Scientific Query) Name
Dr M V Srishyla
Designation
Director-Clinical Medical,Regulatory and Quality
Affiliation
Novo Nordisk India Private Ltd
Address
Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore KARNATAKA 560 066 India
Phone
918861082266
Fax Email Details Contact Person (Public Query)
[email protected] Details Contact Person (Public Query)
Name
Dr Ramesh Jagannathan
Designation
Head Clinical Operations
Affiliation
Novo Nordisk India Private Ltd
Address
Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore Bangalore KARNATAKA 560 066 India
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PDF of Trial CTRI Website URL - http://ctri.nic.in
Phone
919632151938
Fax Email Source of Monetary or Material Support
[email protected] Source of Monetary or Material Support
> Novo Nordisk AS C/O Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 India
Primary Sponsor
Primary Sponsor Details Name
Novo Nordisk AS
Address
c/o Novo Nordisk IPL,Plot No.32, 47 - 50,EPIP Area, Whitefield, Bangalore - 560 066 India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
List of Countries Australia Bulgaria Hungary India Republic of Korea Serbia Thailand Turkey United Arab Emirates
Sites of Study
Name of Principal Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Arthur Joseph Asirvatham
Arthur Asirvatham Hospital
Ground floor, Clinical research department, Arthur Asirvatham Hospital,,No:42-A, Kuruvikaran Salai, Madurai TAMIL NADU
04522535266 04522531977 drajasirvatham@yahoo. co.in
Dr Satish Babu K N
BGS Global Hospitals
BGS Global Hospitals, 1st Floor, Endocrinology department, BGS Health & Education City, #67, Uttarahalli Road, Kengeri, Bangalore-560 060, Karnataka India Bangalore KARNATAKA
9731533636 080-30444192
[email protected]. uk
Dr Amit Patel
BSES Municipal General Hospital,
7th floor, Diabetology Research office,SV Road, Opp. Railway station, Andheri(WEST), Mumbai (Suburban) MAHARASHTRA
9920699789 912226715000
[email protected]
Dr Dukhabandhu Naik
Christian Medical College
810, 2nd floor,Department of Endocrinology,
9843671306 04164200854
[email protected]
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Diabetes and Metabolism, Christian Medical College, Vellore TAMIL NADU
Details of Ethics Committee
Dr D Vijay Sekher Reddy
Gandhi Hospital,
Department of EndocrinologyDepartment of Endocrinology-HOD and Professor room, 3rd floor, Main building, Musheerabad, Secunderabad, Hyderabad ANDHRA PRADESH
9849172161 04027504441 drdvsreddyendo@Yaho o.com
Dr Debmalya Sanyal
KPC Medical college and Hospital
Room no. 13, Block-1, Ground floor, Department of Endocrinology and Diabetology, 1F, Raja S.C. Mullick Road Kolkata WEST BENGAL
9830118388 drdebmalyasanyal@gm ail.com
Dr Anupam Prakash
Lady Harding Medical Room no. 1014, College & Smt. Sucheta Department of Kriplani Hospital, Medicine, Old building,Lady Harding Medical College & Smt. Sucheta Kriplani Hospital, New Delhi DELHI
01123408278 01127662763 prakashanupam@hotm ail.com
Name of Committee
Approval Status
Date of Approval
Is Independent Ethics Committee?
BSES Municipal Approved General Hospital Ethics Committee;BSES Municipal General Hospital Ethics Committee, SV Road, Opp. Railway station, Andheri(WEST), Mumbai-400058 ;Dr. Amit Patel
24/08/2015
No
Ethics committee for Approved human research;Lady Harding Medical college & Associated Hoapitals, Shahid Bhagat Singh Marg, New Delhi110001;Anupam Prakash
06/10/2015
No
Institutional Ethics Approved Committee ( IEC) For Clinical Research;KPC Medical College and Hospital,1F Raja S.C. Mullick Road, Jadavpur, Kolkata-700032, West
17/08/2015
No
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Bengal , India;Dr Debmalya Sanyal Institutional Ethics Committee- BGS Global Hospitals
Approved
03/12/2015
No
Institutional ethics committee;Arthur Asirvatham Hospital, No:42-A, Kuruvikaran Salai, Madhurai-635 ;Dr. Arthur Joseph Asirvatham
Approved
30/06/2015
No
Institutional ethics Approved committee;Principal offices, Gandhi Medical College, Musheerabad, Secunderabad, Telangana-500003 ;Dr. D Vijay Sekher Reddy
13/10/2015
No
Institutional Review Approved Board;Ethics committee Silver, Research Office, First floor, Carman block, Christian Medical College, Vellore
24/08/2015
No
Regulatory Clearance Status from DCGI
Status
Date
Approved/Obtained
12/08/2015
Health Condition / Problems Studied
Health Type
Condition
Patients
Diabetes Mellitus, Type 2
Patients
Type 2 diabetes mellitus
Intervention / Comparator Agent
Type
Name
Details
Intervention
BIAsp
biphasic insulin aspart 30 Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial(32 week) while other oral antidiabetic drugs will be discontinued.
Comparator Agent
IGlar AND IAsp
Drug- insulin glargine Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued. Drug- insulin aspart Injected s.c./subcutaneously once daily. Duration 32 weeks
Inclusion Criteria
Inclusion Criteria Age From
18.00 Year(s)
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Age To
99.00 Year(s)
Gender
Both
Details
-18 Years and older -Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial -Male or female, age at least 18 years at the time of signing informed consent -Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening -Treatment with stable daily dose (for at least 90 days prior to screening) of: – Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and – Sulfonylurea – and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/ or combination products at randomisation -Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes -HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory -Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for ‘main meal’ will be according to the investigator’s discretion
Exclusion Criteria
Exclusion Criteria Details
-Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents) -Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit) -Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2 -Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
Method of Generating Computer generated randomization Random Sequence Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome Change in HbA1c
Secondary Outcome
Timepoints Week 0, Week 32
Outcome
Timepoints
HbA1c below 7.0% without severe hypoglycaemic episodes
After 32 weeks of treatment
Number of treatment emergent hypoglycaemic episodes
Weeks 0-32
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Total daily insulin dose Target Sample Size
Total Sample Size=336 Sample Size from India=46
Phase of Trial
Phase 4
Date of First Enrollment (India)
01/09/2015
Date of First Enrollment (Global)
01/09/2015
Weeks 0-32
Estimated Duration of Years=1 Trial Months=5 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details
None yet
Brief Summary This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.
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