| CTRI Number |
CTRI/2009/091/000485 [Registered on: 21/07/2009] |
| Last Modified On: |
26/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, Placebo- and Active-Controlled,Parallel-Group, Multicenter Study to Determine the Efficacy andSafety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2008-007664-42 |
EudraCT |
| GLP112757 |
Protocol Number |
| NCT00839527 |
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 |
| Designation |
General Manager-Clinical Operations, |
| Affiliation |
GlaxoSmithKline Pharmaceuticals |
| Address |
GlaxoSmithKline Pharmaceuticals, Dr. Annie Besant Road, Worli, Mumbai
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 |
| Designation |
Associate Director Clinical Management |
| Affiliation |
|
| Address |
PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor,Sector 25, Mehrauli Gurgaon Road,
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| 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 |
GlaxoSmithKline
Alternative Development Program
709 Swedeland Road
King of Prussia, PA 19406-0939 |
| 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
Argentina
Brazil
China
Czech Republic
France
Germany
Hong Kong
Mexico
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 = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Paramesh Shamanna |
Bangalore Clinisearch |
4AC-426, Second Block Kalyana Nagar,-560043
Bangalore
KARNATAKA |
+91 8025421333
+91 8025902546
dr_paramesh@hotmail.com |
| Dr. Sanjay Reddy |
Bangalore Diabetes Hospital |
Bangalore Diabetes Hospital, 16-M, Thimaiahaai Rd. Millers tank bed area,,Vasant Nagar-560052
Bangalore
KARNATAKA |
+91 80 22372980
+91 80 22372981
drsanjaycreddy@yahoo.com |
| Dr Ajay Dande |
Dande Diabetes and Heart Care |
Centre N-2, Near Hotel Deepali Executive,Cidco-431001
Aurangabad
BIHAR |
919270033819
912402475001
drdande@yahoo.com |
| Dr. Abhay Mutha |
Diabetes Care and Research Centre |
B-5 , Mittal Court,478 Rasta Peth-411011
Pune
MAHARASHTRA |
+91 020 26124232
+91-020-26124232
drmutha@pn2.vsnl.net.in |
| Dr. K M Prasanna Kumar |
Gokula Metropolis Clinical Research Center |
M. S. Ramaiah Memorial Hospital,Dept. of Endocrinology and metabolism, ,New BEL Road, M.S.R Nagar, MSRIT Post-560054
Bangalore
KARNATAKA |
+91 80-4052 8411
+91 80 40528402
maheshwariamita@gmail.com |
| Dr. Chittaranjan Yajnik |
KEM Hospital |
Department of Endocrinology,Sardar Moodliar Road, Rasta Peth,-411011
Pune
MAHARASHTRA |
+91 20 4037366
+91 20 66405731
diabetestrials@yahoo.com |
| Dr. Vijay Viswanathan |
M.V.Hospital for diabetes and Diabetic Research |
4,WestMadha church street Royapuram,-600013
Chennai
TAMIL NADU |
+91 4428259633
+91 4428259633
drvijay@mvdiabetes.com |
| Dr. Viswanathan Mohan |
Madras Diabetes Research Foundation |
Madras Diabetes research foundation No. 4, ,Conran Smith Road, -600086
Chennai
TAMIL NADU |
+9144-283-5904 852
+9144 2835 0935
drmohan@vsnl.net |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Bangalore Diabetes Hospital Ethics Committee |
Approved |
| Ethical Control committee, Plot No. 06, shree Ganesh Housing Society, Sawarkar Chowk, N-9 D, CIDCO, Aurangabad- 431001 |
Approved |
| Ethics committee - Diabetes Research Centre |
Approved |
| Ethics Committee Diabetes Care and Research Centre |
Approved |
| Ethics Committee of KEM Hospital Research Centre |
Approved |
| M. S. Ramaiah Medical College and Teaching Hospital Ethical Review Board |
Approved |
| Madras Diabetes Research Foundation Institutional Ethics committee |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type - 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Albiglutide |
30mg - 50mg, weekly subcutaneous injection |
| Comparator Agent |
Placebo |
weekly subcutaneous injection |
|
Inclusion Criteria
Modification(s)
|
| 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 inclusive |
|
| ExclusionCriteria |
| Details |
1. females who are pregnant, lactating, or less than 6 weeks post-partum
2. current symptomatic heart failure (NYHA Class II-IV)
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| HbA1c change from baseline |
Time Frame: one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. FPG change from baseline
2. body weight change from baseline |
Time Frame: one year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="600"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
05/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
13/04/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This randomized, double-blind, placebo- and active-controlled, 3 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide in combination with metformin and glimepiride compared with metformin plus glimepiride and placebo and metformin plus glimepiride and pioglitazone in subjects with type 2 diabetes mellitus. Subjects with type 2 diabetes mellitus whose glycemia is not adequately controlled with their current regimen of metformin plus a sulfonylurea will be recruited into the study. Subjects should be receiving at least 1500 mg of immediate release (IR) metformin daily, unless there is documentation that a lower dose is the subject?s maximum tolerated dose. Subjects must be receiving a sulfonylurea with a dose equivalent to 4 mg glimepiride. Subjects taking a sulfonylurea other than glimepiride will be switched to glimepiride during the Run-in/Stabilization Period. Subjects will continue taking IR metformin for the duration of their participation in the study. The study will comprise 4 study periods: Screening, Run-in/Stabilization, Treatment, and Posttreatment Follow-up. During the screening visit, informed consent and medical history will be obtained and subjects will undergo an eligibility assessment (complete physical examination, vital sign measurements, laboratory testing, electrocardiogram [ECG], standard urinalysis, pregnancy testing, drug screen, and serology screen). In addition, glycosylated hemoglobin (HbA1c) levels may be determined using a Metrika kit or other finger-stick procedure to provide a guideline for investigators on subject eligibility; the official HbA1c value that determines subject eligibility is measured by the central laboratory at the end of the Run-in/Stabilization Period (Visit 7). Fasting C-peptide is also measured at the screening visit and should be ≥0.8 ng/mL (≥0.26 nmol/L). Eligible subjects will be allowed to enter the 6-week Runin/ Stabilization Period. At the end of the Run-in/Stabilization Period, HbA1c is measured and the results must be between 7.0% and 10.0%, inclusive, for the subject to be eligible for the study. Eligible subjects will be stratified by HbA1c, based on the value obtained at Visit 7, (<8.0% versus ≥8.0%), history of prior myocardial infarction (MI) (yes versus no), and age (<65 years versus ≥65 years). Approximately 600 subjects will be randomly assigned to 1 of the following 3 treatment groups in a 5:5:2 ratio such that 1. Metformin + open-label glimepiride (4 mg daily) + pioglitazone (30 mg daily; treatment-masked uptitration if needed to 45 mg daily) + matching albiglutide placebo 2. Metformin + open-label glimepiride (4 mg daily) + pioglitazone matching placebo + albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) 3. Metformin + open-label glimepiride (4 mg daily) + pioglitazone matching placebo + albiglutide matching placebo The duration of the Treatment Period for the assessment of primary efficacy and safety is 52 weeks from the time of randomization, followed by an additional 104 weeks of. The participating countries apart from India in the trial are: Argentina, Brazil, Czech Republic, China, France, Germany, Hong-Kong, Korea, Mexico, Peru, Philippines, Russia South Africa, Spain, Taiwan, United Kingdom, USA. The number of patients proposed to be recruited from India is 60 with planned date of enrollment 01-Aug-2009. Screening of subjects closed on 13-Nov-2009 and total of 1442 patients were screened globally with 77 in India |