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Clinical Trial Details (PDF Generation Date :- Thu, 12 Dec 2019 06:34:02 GMT)

CTRI Number CTRI/2009/091/000484 [Registered on: 21/07/2009] -

Last Modified On 19/08/2019
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Biological
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Study of Safety and Efficacy of Albiglutide in Type 2 Diabetes
Scientific Title of A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter Study to Determine
Study the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without
Metformin in Subjects with Type 2 Diabetes Mellitus.
Secondary IDs if Any Secondary ID Identifier
2008-007662-37 EudraCT
GLP112755 - dated 25-November-2008 Protocol Number
NCT00849056 ClinicalTrials.gov
Details of Principal Details of Principal Investigator
Investigator or overall
Name
Trial Coordinator
(multi-center study) Designation
Affiliation
Address

Phone
Fax
Email
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Jeroze J Dalal
Query)
Designation General Manager Clinical Operations
Affiliation GlaxoSmithKline Pharmaceuticals
Address GlaxoSmithKline Pharmaceuticals, Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400 030
India
Phone 912224959395
Fax 912224947415
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Arun Sundriyal
Designation Associate Director Clinical Management
Affiliation
Address PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor,Sector 25, Mehrauli Gurgaon Road, India
Gurgaon
HARYANA
122002
India
Phone 911244739903

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Fax 911244739999
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> GlaxoSmithKline Alternative Development Program 709 Swedeland Road King of Prussia, PA
19406-0939
Primary Sponsor Primary Sponsor Details
Name GlaxoSmithKline
Address GlaxoSmithKline Alternative Development Program 709 Swedeland
Road King of Prussia, PA 19406-0939
Type of Sponsor Pharmaceutical industry-Global
Details of Secondary Name Address
Sponsor
PPD Pharmaceutical Development India Pvt Ltd 01-Dynasty B-Wing (Kanakia Spaces)
Andheri-Kurla Road, Andheri East,
Mumbai-400059, India
Countries of List of Countries
Recruitment
Argentina
Brazil
China
Czech Republic
France
Germany
Hong Kong
India
Mexico
Peru
Philippines
Republic of Korea
Russian Federation
South Africa
Spain
Taiwan
United Kingdom
United States of America
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr. Paramesh Bangalore Diabetes Bangalore Clinisearch, +91 8025421333
Shamanna Centre 4AC-426 Second +91 8025902546
Block,Kalyana dr_paramesh@hotmail.
Nagar-560043 com
Bangalore
KARNATAKA
Dr. Sanjay Reddy Bangalore Diabetes Bangalore Diabetes +91 80 22372980
Hospital, Hospital, ,16-M, +91 80 22372981
Thimaiahaai Rd. Millers drsanjaycreddy@yahoo
tank bed area, Vasant .com
Nagar-560052
Bangalore
KARNATAKA
Dr Ajay Dande Dande Diabetes and Centre N-2, Near Hotel 912402475001
Heart Care, Deepali Executive, 912402475001
,Cidco-431001 [email protected]

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Aurangabad
MAHARASHTRA
Dr. Abhay Mutha Diabetes Care and B-5 , Mittal Court, ,478 +91 020 26124232
Research Centre Rasta Peth,-411011 +91-020-26124232
Pune [email protected]
MAHARASHTRA n
Dr. K M Prasanna Gokula Metropolis Dept. of Endocrinology +91 80-4052 8411
Kumar Clinical Research and metabolism,New +91 80-4052 8402
Center, M. S. Ramaiah BEL Road, M.S.R [email protected]
Memorial Hospital, Nagar, MSRIT
Post,-560054
Bangalore
KARNATAKA
Dr. Yajnik Chittaranjan KEM Hospital KEM Hospital, +91 20 4037366
Department of +91 20 66405731
Endocrinology, Sardar [email protected]
Moodliar Road,,Rasta om
Peth,-411011
Pune
MAHARASHTRA
Dr. Vijay Viswanathan M.V. Hospital For M.V.Hospital for +91 4428259633
Diabetes Pvt. Ltd. diabetes and Diabetic +91 4428259633
Research,4,West [email protected]
Madha church street m
Royapuram,-600013
Chennai
TAMIL NADU
Dr. Viswanathan Mohan Madras Diabetes Madras Diabetes +9144-283-5904 x852
Research Foundation research foundation No. +9144 2835 0935
4, ,Conran Smith [email protected]
Road,-600086
Chennai
TAMIL NADU
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Bangalore Diabetes Approved 26/06/2009 No
Hospital Ethics
Committee
Ethical Control Approved 03/04/2009 Yes
committee, Plot No. 06,
shree Ganesh Housing
Society, Sawarkar
Chowk, N-9 D, CIDCO,
Aurangabad- 431001
Ethics Committee - Approved 02/06/2009 No
Diabetes Research
Centre
Ethics Committee Approved 14/04/2009 No
Diabetes Care and
Research Centre
Ethics Committee of Approved 07/05/2009 No
KEM Hospital Research
Centre
M. S. Ramaiah Medical Approved 05/05/2009 No
College and Teaching
Hospital Ethical Review
Board

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Madras Diabetes Approved 23/05/2009 No

Research Foundation
Institutional Ethics
committee
Medisys Clinisearch Approved 24/04/2009 No
ethical Review Board
Regulatory Clearance Status Date
Status from DCGI
Approved/Obtained 01/07/2009
Health Condition / Health Type Condition
Problems Studied
Patients Diabetes Mellitus, Type 2
Patients Type 2 diabetes mellitus with other specified
complications
Intervention / Type Name Details
Comparator Agent
Intervention Pioglitazone or (metformin Plus 30mg weekly subcutaneous
pioglitazone) Plus albiglutide injection
(30 mg weekly)
Comparator Agent Pioglitazone or (metformin Plus weekly subcutaneous injection
pioglitazone)Plus albiglutide
matching placebo
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 99.00 Year(s)
Gender Both
Details Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both

1. Type 2 diabetes
2. BMI 20-45kg/m2

Exclusion Criteria Exclusion Criteria

Details 1. NYHA Class II to IV heart failure 2. females who are pregnant,
lactating, or less than 6 weeks post-partum
Method of Generating Stratified randomization
Random Sequence
Method of Centralized
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome Outcome Timepoints
HbA1c change from baseline Time frame: 1 year
Secondary Outcome Outcome Timepoints
1. HbA1c change from Baseline over time Time frame: 1 year
2. FPG change from baseline
3. Body weight change from baseline
Target Sample Size Total Sample Size=300
Sample Size from India=40
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
Phase of Trial Phase 3
Date of First 29/10/2009
Enrollment (India)
Date of First 12/02/2009

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Enrollment (Global)
Estimated Duration of Years=4
Trial Months=0
Days=0
Recruitment Status of Completed
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details No
Brief Summary This randomized, double-blind, placebo-controlled, 2-parallel-group, multicenter study evaluates the
efficacy and safety of a 30 mg weekly subcutaneously injected dose of albiglutide in combination
with pioglitazone (with or without metformin) as compared with pioglitazone (with or without
metformin) in subjects with type 2 diabetes mellitus. Subjects with type 2 diabetes mellitus who are
inadequately controlled on their current regimen of pioglitazone (with or without metformin) will be
recruited into the study. Subjects receiving pioglitazone as part of their antidiabetic therapy should
be on a stable dose of at least 30 mg daily, unless there is documentation that a lower dose (i.e., 15
mg) is the subject?s maximum tolerated dose (MTD). Subjects receiving metformin should be
receiving at least 1500 mg of immediate release metformin daily, unless there is documentation that
a lower dose is the subject?s MTD. Subjects will continue on their current dose of pioglitazone (with
or without metformin) for the duration of their participation in the study.The number of patients
proposed to be recruited from India is 40 with planned date of enrollment 01-Aug-2009. Screening
of subject closed on 08-Oct-2009 and a total of 669 patients were screened globally and 5 in India.

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