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A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
First received: February 5, 2009
Last updated: May 22, 2014
Last verified: April 2014
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide
Drug: insulin glargine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 1060 par. were screened; 779 par. were randomized, and 745 par. received >=1 treatment dose.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (156 Weeks)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea  
STARTED     504     241  
COMPLETED     308     164  
NOT COMPLETED     196     77  
Adverse Event                 50                 11  
Protocol Violation                 12                 3  
Noncompliance                 21                 14  
Severe or Repeated Hypoglycaemia                 1                 0  
Lost to Follow-up                 19                 18  
Withdrawal by Subject                 81                 29  
Physician Decision                 6                 1  
Termination of Study/Site by GSK                 1                 0  
Missing                 3                 1  
Pregnancy                 2                 0  

Period 2:   Follow-up Period (8 Weeks)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea  
STARTED     504 [1]   241 [1]
COMPLETED     408     190  
NOT COMPLETED     96     51  
Adverse Event                 10                 5  
Noncompliance                 6                 5  
Lost to Follow-up                 38                 22  
Did not Enter Follow-up Period                 7                 7  
Withdrawn from Follow-up Participation                 26                 12  
Physician Decision                 2                 0  
Termination of Study/Site by GSK                 2                 0  
Withdrawal by Subject                 2                 0  
Missing                 3                 0  
[1] Participants withdrawing from the Treatment Period entered the Follow-up Period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea     Total  
Number of Participants  
[units: participants]
  504     241     745  
Age  
[units: Years]
Mean ± Standard Deviation
  55.8  ± 9.33     54.7  ± 9.75     55.5  ± 9.48  
Gender  
[units: Participants]
     
Female     218     109     327  
Male     286     132     418  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     130     64     194  
American Indian or Alaskan Native     3     1     4  
Asian - Central/South Asian Heritage     7     5     12  
Asian - East Asian Heritage     2     1     3  
Asian - Japanese Heritage     0     1     1  
Asian - South East Asian Heritage     16     8     24  
Native Hawaiian or Other Pacific Islander     1     0     1  
White - Arabic/North African Heritage     7     2     9  
White - White/Caucasian/European Heritage     342     158     500  
Other - Central American Indian     1     0     1  
Other - Hispanic     0     1     1  
Other - Mexican     1     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Change From Baseline in HbA1c at Week 156   [ Time Frame: Baseline and Week 156 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156   [ Time Frame: Baseline and Week 156 ]

5.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156   [ Time Frame: Week 156 ]

7.  Secondary:   Time to Hyperglycemia Rescue   [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ]

8.  Secondary:   Change From Baseline in Body Weight at Week 52   [ Time Frame: Baseline and Week 52 ]

9.  Secondary:   Change From Baseline in Body Weight at Week 156   [ Time Frame: Baseline and Week 156 ]

10.  Secondary:   Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Albiglutide Plasma Concentrations at Week 8 and Week 24   [ Time Frame: Weeks 8 and 24 ]


  Serious Adverse Events
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Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Additional Description SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Serious Adverse Events
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea  
Total, serious adverse events      
# participants affected / at risk     92/504 (18.25%)     46/241 (19.09%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     3/504 (0.60%)     0/241 (0.00%)  
Idiopathic thrombocytopenic purpura † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Iron deficiency anaemia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Cardiac disorders      
Coronary artery disease † 1    
# participants affected / at risk     5/504 (0.99%)     2/241 (0.83%)  
Acute myocardial infarction † 1    
# participants affected / at risk     3/504 (0.60%)     2/241 (0.83%)  
Angina unstable † 1    
# participants affected / at risk     2/504 (0.40%)     3/241 (1.24%)  
Cardiac failure congestive † 1    
# participants affected / at risk     2/504 (0.40%)     2/241 (0.83%)  
Atrial fibrillation † 1    
# participants affected / at risk     3/504 (0.60%)     0/241 (0.00%)  
Myocardial infarction † 1    
# participants affected / at risk     3/504 (0.60%)     0/241 (0.00%)  
Acute coronary syndrome † 1    
# participants affected / at risk     1/504 (0.20%)     1/241 (0.41%)  
Angina pectoris † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Arteriosclerosis coronary artery † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Atrial flutter † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Bradycardia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Cardiomyopathy † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Conduction disorder † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Coronary artery insufficiency † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Sinus bradycardia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Ventricular tachycardia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Eye disorders      
Cataract † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Retinal detachment † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gastrointestinal disorders      
Lower gastrointestinal haemorrhage † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Abdominal hernia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Abdominal pain upper † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Ascites † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Diarrhoea † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Haemorrhoids † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Pancreatitis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Peptic ulcer † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Umbilical hernia † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
General disorders      
Chest pain † 1    
# participants affected / at risk     5/504 (0.99%)     4/241 (1.66%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     4/504 (0.79%)     0/241 (0.00%)  
Death † 1    
# participants affected / at risk     2/504 (0.40%)     1/241 (0.41%)  
Device leakage † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Generalised oedema † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Sudden cardiac death † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Hepatobiliary disorders      
Cholecystitis Acute † 1    
# participants affected / at risk     0/504 (0.00%)     3/241 (1.24%)  
Cholelithiasis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Hepatitis † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     4/504 (0.79%)     0/241 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     3/504 (0.60%)     0/241 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     1/504 (0.20%)     2/241 (0.83%)  
Osteomyelitis † 1    
# participants affected / at risk     3/504 (0.60%)     0/241 (0.00%)  
Diverticulitis † 1    
# participants affected / at risk     0/504 (0.00%)     2/241 (0.83%)  
Lobar pneumonia † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Urinary tract infection † 1    
# participants affected / at risk     0/504 (0.00%)     2/241 (0.83%)  
Appendicitis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Arthritis bacterial † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Bacterial pyelonephritis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Bronchopneumonia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Epiglottitis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Eye abscess † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gangrene † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Hepatitis B † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Localised infection † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Perirectal abscess † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Staphylococcal infection † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Tracheobronchitis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Injury, poisoning and procedural complications      
Arterial injury † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Femur fracture † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Gastroenteritis radiation † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Heat stroke † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Hip fracture † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Meniscus lesion † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Road traffic accident † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Seroma † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Skeletal injury † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Toxicity to various agents † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Wound dehiscence † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Metabolism and nutrition disorders      
Hypoglycaemia † 1    
# participants affected / at risk     1/504 (0.20%)     2/241 (0.83%)  
Musculoskeletal and connective tissue disorders      
Osteoarthritis † 1    
# participants affected / at risk     2/504 (0.40%)     3/241 (1.24%)  
Arthritis † 1    
# participants affected / at risk     0/504 (0.00%)     2/241 (0.83%)  
Cervical spinal stenosis † 1    
# participants affected / at risk     1/504 (0.20%)     1/241 (0.41%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Bursitis † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Neuropathic arthropathy † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Pathological fracture † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Periarthritis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Rotator cuff syndrome † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Spondylolisthesis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Acute myeloid leukaemia † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Breast cancer † 1    
# participants affected / at risk     1/504 (0.20%)     1/241 (0.41%)  
Endometrial cancer † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Lung adenocarcinoma metastatic † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Lung neoplasm † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Lung neoplasm malignant † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Lung squamous cell carcinoma stage unspecified † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Meningioma † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Myelodysplastic syndrome † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Oesophageal carcinoma † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Prostate cancer † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Sarcoma † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Nervous system disorders      
Cerebrovascular accident † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Transient ischaemic attack † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Migraine † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Neuropathy peripheral † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Syncope † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Confusional state † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Schizophrenia † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Renal and urinary disorders      
Calculus urinary † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Hydronephrosis † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/504 (0.20%)     1/241 (0.41%)  
Renal failure acute † 1    
# participants affected / at risk     1/504 (0.20%)     1/241 (0.41%)  
Calculus ureteric † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Reproductive system and breast disorders      
Dysfunctional uterine bleeding † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Menorrhagia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     2/504 (0.40%)     0/241 (0.00%)  
Acute respiratory failure † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Bronchospasm † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Dyspnoea † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Pneumothorax † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Pulmonary embolism † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Pulmonary hypertension † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Skin and subcutaneous tissue disorders      
Diabetic foot † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Diabetic vascular disorder † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Haematoma † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Haemorrhage † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Hypertension † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Hypotension † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Peripheral ischaemia † 1    
# participants affected / at risk     1/504 (0.20%)     0/241 (0.00%)  
Peripheral vascular disorder † 1    
# participants affected / at risk     0/504 (0.00%)     1/241 (0.41%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
Study First Received: February 5, 2009
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration