CTRI Trial Data - Clinical Trials Registry - India

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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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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 [email protected] 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 [email protected] 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 [email protected] 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 [email protected] 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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CTRI Trial Data - Clinical Trials Registry - India

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