| CTRI Number |
CTRI/2010/091/001238 [Registered on: 29/09/2010] |
| Last Modified On: |
27/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
|
Scientific Title of Study
Modification(s)
|
A Randomized, Open-Label, Parallel-Group, Multicenter Study
to Determine the Efficacy and Safety of Albiglutide as
Compared With Liraglutide in Subjects With Type 2 Diabetes
Mellitus. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GLP114179 dated 22 Mar 2010 |
Protocol Number |
| NCT01128894 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Jeroze J Dalal General Manager Clinical Operations |
| Designation |
General Manager-Clinical Operations |
| Affiliation |
GlaxoSmithKline Pharmaceuticals |
| Address |
GlaxoSmithKline Pharmaceuticals, Dr. Annie Besant Road
Worli
Mumbai
MAHARASHTRA
400030
India |
| Phone |
912224959395 |
| Fax |
912224947415 |
| Email |
jeroze.j.dalal@gsk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arun Sundriyal Associate Director Clinical Management |
| Designation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt Ltd., Vatika Business Centre, First India Place, 2nd floor, Block B, Sushant Lok Phase – 1 Mehrauli Gurgaon Road, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
911244028861 |
| Fax |
911244028874 |
| Email |
Arun.Sundriyal@ppdi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| GlaxoSmithKline, Alternative Development Program
709 Swedeland Road
King of Prussia, PA 19406-0939 |
|
Primary Sponsor
Modification(s)
|
| Name |
GlaxoSmithKline |
| Address |
Alternative Development Program
709 Swedeland Road
King of Prussia, PA 19406-0939, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
01-Dynasty B-Wing (Kanakia Spaces) Andheri-Kurla Road, Andheri East, Mumbai-400059, India |
|
Countries of Recruitment
Modification(s)
|
India
Australia
Brazil
Colombia
Germany
Peru
Philippines
Republic of Korea
Russian Federation
South Africa
Spain
Taiwan
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Usha Sriram |
Associate in Clinical Endocrinology Education and Research (ACEER) |
7/12, 15th Cross Street, ,Sastri Nagar, Adyar-600020
Chennai
TAMIL NADU |
+91 44 2446 0762
+91 44 24460760
aceer_chennai@yahoo.com |
| Dr. Paramesh Shamanna |
Bangalore Clinisearch |
No 416, 4th Cross, 2nd Block,,Kalyan Nagar-560043
Bangalore
KARNATAKA |
+91 8025421333
+91 8025902546
dr_paramesh@hotmail.com |
| Dr. Sanjay Reddy A. C. |
Bangalore Diabetes Hospital, |
16/M, Thimmaiah Road,,Millar Tank Bed Area, Vasanthnagar,-560052
Bangalore
KARNATAKA |
+91 80 22372980
+91 80 22372981
drsanjaycreddy@yahoo.com |
| Dr. Nadeem Rais |
Chowpatty Medical Center |
3 Baig Mansion,,Babulnath Road-40007
Mumbai
MAHARASHTRA |
+91-9821062696
+91-22-23642178
cmctrials@gmail.com |
| Dr. Sujit Chandatreya |
Endocare Clinic |
Mohiniraj Building,Gangapur Road-422013
Nashik
MAHARASHTRA |
+91 253 2572805
+91 253 2317466
sujitchandratreya@yahoo.com |
| Dr. K M. Prasanna Kumar |
Gokula Metropolis Clinical Research Center Basement, |
M. S. Ramaiah Memorial Hospital , MSRIT Post, ,New BEL Road,-560054
Bangalore
KARNATAKA |
+91 80-4052 8411
+91 80-4052 8402
drkmp@gmail.com |
| Dr. Mathew Thomas |
Health & Research Centre, |
1st Floor Deviscans Building,Kumarapuram Medical College P O,-695011
|
+91-471-2554911
+91-471-2554913
healthtrials@gmail.com |
| Dr. Shehla Shaikh |
K G N Diabetes Research Institute |
Patel Arcade, 1st Floor, Shop No. 9 & 10,Kedy Complex, Nagpada-400008
Mumbai
MAHARASHTRA |
+91 22 2377 7800
+91 22 2374 3820
drshehla@rediffmail.com |
| Dr. Vijay Viswanathan |
M. V. Hospital for Diabetes and Diabetes Research Centre, |
No. 4, West Madha church street,,Royapuram,-600013
Chennai
TAMIL NADU |
+91 4428259633
+91 4428259633
drvijay@mvdiabetes.com |
| Dr. Viswanathan Mohan |
Madras Diabetes Research Foundation, |
No. 4, Conron Smith Road,,Gopalpuram,-600086
Chennai
TAMIL NADU |
+91-44-283-5904 x852
+91-44-2835 0935
drmohan@vsnl.net |
| Dr Kavitha Saravu |
Manipal Centre for Clinical Research & Manipal University |
4th floor , Shirdi Sai Baba Cancer Block,Kasturba Hospital , Post Box No. 7,-576 104
|
944810763
8202571999
kavithasaravu@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Bangalore Diabetes Hospital Ethics Committee |
Approved |
| Chowpatty Medical Centre Ethics Review Board |
Approved |
| Ethics committee - Diabetes Research Centre |
Approved |
| Ethics Committee Manipal University |
Approved |
| Independent Human Ethics Committee |
Approved |
| Institutional Ethics Committee- MDRF |
Not Applicable |
| K G N Ethics Committee |
Approved |
| M. S. Ramaiah Medical College and Teaching Hospital Ethical Review Board |
Approved |
| National Ethics Committee |
Not Applicable |
| Veridian Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Albiglutide: Experimental |
weekly subcutaneous injection |
| Comparator Agent |
Liraglutide: Active Comparator |
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
2. BMI more than or equal to 20kg per m2 and less than or equal to 45 kg per m2
3. Fasting C-peptide more than or equal to 0.8 ng per mL (more than or equal to 0.26 nmol per L)
4. HbA1c between 7.0 percent and 10.0 percent, inclusive
5. Female subjects of childbearing potential must be practicing adequate contraception.
|
|
| ExclusionCriteria |
| Details |
1. History of cancer
2. History of treated diabetic gastroparesis
3. Current biliary disease or history of pancreatitis
4. History of significant GI surgery
5. Recent clinically significant cardiovascular and/or cerebrovascular disease
6. Hypertension
7. History of human immunodeficiency virus infection
8. History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
9. History of alcohol or substance abuse
10. Female subject is pregnant, lactating, or <6 weeks postpartum
11. Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
12. History of type 1 diabetes mellitus
Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
13. Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
14. History or family history of thyroid disease
Note: Subjects above the age of 65 years will not be enrolled in the study from India, as per Regulatory approval granted by Drugs Controller General of India (DCGI). |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Evaluation of change from baseline of HbA1c levels (representing glycemic efficacy) of albiglutide as compared with liraglutide. |
Time Frame: 32 weeks from baseline |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change from Baseline in body weight |
Time Frame: 32 weeks from baseline |
|
Target Sample Size
Modification(s)
|
Total Sample Size="800"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
07/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study. Apart from India, other country participating in the study are Germany, Russia, Spain, UK, Israel, South Africa, USA, Brazil, Columbia, Peru, Australia, Philippines, South Korea, Taiwan. The number of subjects planned to be recruited from India is 50 and first subject enrollment was projected 30 Sep 2010. With very narrow gap in DCGI approval and global recruitment closure, no site from India could recruit any subject in India.
|