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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:
ClinicalTrials.gov Identifier:
NCT00838916
First Posted: February 9, 2009
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide
Drug: insulin glargine

  Participant Flow
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      218  43.3%      109  45.2%      327  43.9% 
Male      286  56.7%      132  54.8%      418  56.1% 
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
  Hide Serious Adverse Events

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




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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
First Submitted: February 5, 2009
First Posted: February 9, 2009
Results First Submitted: April 17, 2014
Results First Posted: June 4, 2014
Last Update Posted: January 9, 2017