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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

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.
 
ClinicalTrials.gov Identifier: NCT00313313
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : September 25, 2009
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Saxagliptin
Drug: Glyburide
Drug: Placebo
Drug: Metformin
Enrollment 768
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg
Hide Arm/Group Description The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Period Title: Overall Study
Started 248 253 267
Completed 185 [1] 187 [2] 185 [3]
Not Completed 63 66 82
Reason Not Completed
Lack of Efficacy             14             9             20
Withdrawal of consent by subject             18             17             31
Lost to Follow-up             10             7             9
Adverse Event             15             16             12
Physician Decision             2             6             4
Poor/Noncompliance             3             6             2
Pregnancy             1             2             0
Death             0             0             2
Subject No Longer Meets Study Criteria             0             3             2
[1]
61 subjects completed the study without being rescued
[2]
55 subjects completed the study without being rescued
[3]
26 subjects completed the study without being rescued
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg Total
Hide Arm/Group Description The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated. Total of all reporting groups
Overall Number of Baseline Participants 248 253 267 768
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 253 participants 267 participants 768 participants
55.36  (9.58) 54.85  (9.96) 55.06  (10.69) 55.09  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 253 participants 267 participants 768 participants
Female
135
  54.4%
143
  56.5%
144
  53.9%
422
  54.9%
Male
113
  45.6%
110
  43.5%
123
  46.1%
346
  45.1%
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Hide Description Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg
Hide Arm/Group Description:
The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Overall Number of Participants Analyzed 246 250 264
Mean (Standard Error)
Unit of Measure: percent
Baseline Mean 8.36  (0.057) 8.48  (0.056) 8.44  (0.055)
Week 24 Mean 7.83  (0.074) 7.83  (0.074) 8.52  (0.077)
Adjusted Mean Change from Baseline -0.54  (0.059) -0.64  (0.059) 0.08  (0.057)
2.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg
Hide Arm/Group Description:
The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Overall Number of Participants Analyzed 247 252 265
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline Mean 170.1  (2.67) 175.0  (2.79) 174.4  (2.64)
Week 24 Mean 164.4  (2.76) 164.6  (2.76) 174.6  (2.93)
Adjusted Mean Change from Baseline -7.1  (2.42) -9.7  (2.39) 0.7  (2.33)
3.Secondary Outcome
Title Percentage of Participants Achieving A1C < 7% at Week 24
Hide Description Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg
Hide Arm/Group Description:
The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Overall Number of Participants Analyzed 246 250 264
Measure Type: Number
Unit of Measure: Percentage of participants
22.4 22.8 9.1
4.Secondary Outcome
Title Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Hide Description Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg Placebo + Glyburide 7.5 mg
Hide Arm/Group Description:
The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Overall Number of Participants Analyzed 190 195 204
Mean (Standard Error)
Unit of Measure: mg*min/dL
Baseline Mean 49124  (677.2) 50342  (669.0) 51801  (656.9)
Week 24 Mean 45402  (681.5) 45391  (699.3) 52416  (703.7)
Adjusted Mean Change from Baseline -4296  (595.0) -5000  (585.5) 1196  (574.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + Glyburide 7.5 mg Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg
Hide Arm/Group Description The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated. The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
All-Cause Mortality
Placebo + Glyburide 7.5 mg Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo + Glyburide 7.5 mg Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/267 (8.61%)   18/248 (7.26%)   12/253 (4.74%) 
Cardiac disorders       
ANGINA PECTORIS † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CARDIOGENIC SHOCK † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
MYOCARDIAL ISCHAEMIA † 1  0/267 (0.00%)  2/248 (0.81%)  0/253 (0.00%) 
MYOCARDIAL INFARCTION † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CORONARY ARTERY DISEASE † 1  1/267 (0.37%)  1/248 (0.40%)  0/253 (0.00%) 
ACUTE MYOCARDIAL INFARCTION † 1  2/267 (0.75%)  1/248 (0.40%)  1/253 (0.40%) 
ATRIOVENTRICULAR BLOCK COMPLETE † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
Ear and labyrinth disorders       
VERTIGO † 1  0/267 (0.00%)  1/248 (0.40%)  1/253 (0.40%) 
Gastrointestinal disorders       
ASCITES † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
UMBILICAL HERNIA † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
SALIVARY GLAND MASS † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
UPPER GASTROINTESTINAL HAEMORRHAGE † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
General disorders       
ASTHENIA † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
CHEST PAIN † 1  0/267 (0.00%)  2/248 (0.81%)  0/253 (0.00%) 
SUDDEN CARDIAC DEATH † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
Hepatobiliary disorders       
CHOLECYSTITIS † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CHOLELITHIASIS † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CHOLECYSTITIS ACUTE † 1  0/267 (0.00%)  0/248 (0.00%)  2/253 (0.79%) 
Infections and infestations       
PNEUMONIA † 1  3/267 (1.12%)  0/248 (0.00%)  0/253 (0.00%) 
APPENDICITIS † 1  0/267 (0.00%)  2/248 (0.81%)  0/253 (0.00%) 
PYELONEPHRITIS † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
VIRAL INFECTION † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
WOUND INFECTION † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CELLULITIS ORBITAL † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
Injury, poisoning and procedural complications       
LOWER LIMB FRACTURE † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
POST-TRAUMATIC PAIN † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
ROAD TRAFFIC ACCIDENT † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
GASTROINTESTINAL INJURY † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
Metabolism and nutrition disorders       
HYPOGLYCAEMIA † 1  0/267 (0.00%)  1/248 (0.40%)  1/253 (0.40%) 
Musculoskeletal and connective tissue disorders       
OSTEOARTHRITIS † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ADENOMA BENIGN † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
GASTRIC CANCER † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
PROSTATE CANCER † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
THYROID NEOPLASM † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
MYELODYSPLASTIC SYNDROME † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
Nervous system disorders       
SYNCOPE † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
HAEMORRHAGIC STROKE † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
CEREBROVASCULAR ACCIDENT † 1  1/267 (0.37%)  1/248 (0.40%)  0/253 (0.00%) 
Renal and urinary disorders       
NEPHROLITHIASIS † 1  3/267 (1.12%)  0/248 (0.00%)  0/253 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
COUGH † 1  1/267 (0.37%)  0/248 (0.00%)  0/253 (0.00%) 
HAEMOPTYSIS † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
BRONCHITIS CHRONIC † 1  0/267 (0.00%)  1/248 (0.40%)  0/253 (0.00%) 
Vascular disorders       
EXTREMITY NECROSIS † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
PERIPHERAL VASCULAR DISORDER † 1  0/267 (0.00%)  0/248 (0.00%)  1/253 (0.40%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Glyburide 7.5 mg Saxagliptin 2.5 mg + Glyburide 7.5 mg Saxagliptin 5 mg + Glyburide 7.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   163/267 (61.05%)   144/248 (58.06%)   154/253 (60.87%) 
Gastrointestinal disorders       
DIARRHOEA † 1  27/267 (10.11%)  22/248 (8.87%)  16/253 (6.32%) 
DYSPEPSIA † 1  8/267 (3.00%)  13/248 (5.24%)  10/253 (3.95%) 
GASTRITIS † 1  9/267 (3.37%)  13/248 (5.24%)  8/253 (3.16%) 
ABDOMINAL PAIN † 1  6/267 (2.25%)  16/248 (6.45%)  7/253 (2.77%) 
Infections and infestations       
INFLUENZA † 1  27/267 (10.11%)  21/248 (8.47%)  19/253 (7.51%) 
PHARYNGITIS † 1  15/267 (5.62%)  11/248 (4.44%)  19/253 (7.51%) 
NASOPHARYNGITIS † 1  29/267 (10.86%)  21/248 (8.47%)  26/253 (10.28%) 
PHARYNGOTONSILLITIS † 1  11/267 (4.12%)  13/248 (5.24%)  5/253 (1.98%) 
URINARY TRACT INFECTION † 1  32/267 (11.99%)  33/248 (13.31%)  42/253 (16.60%) 
UPPER RESPIRATORY TRACT INFECTION † 1  25/267 (9.36%)  17/248 (6.85%)  24/253 (9.49%) 
Metabolism and nutrition disorders       
DYSLIPIDAEMIA † 1  12/267 (4.49%)  11/248 (4.44%)  13/253 (5.14%) 
Musculoskeletal and connective tissue disorders       
BACK PAIN † 1  18/267 (6.74%)  18/248 (7.26%)  16/253 (6.32%) 
ARTHRALGIA † 1  20/267 (7.49%)  18/248 (7.26%)  20/253 (7.91%) 
PAIN IN EXTREMITY † 1  19/267 (7.12%)  14/248 (5.65%)  15/253 (5.93%) 
Nervous system disorders       
HEADACHE † 1  23/267 (8.61%)  23/248 (9.27%)  25/253 (9.88%) 
Respiratory, thoracic and mediastinal disorders       
COUGH † 1  17/267 (6.37%)  19/248 (7.66%)  15/253 (5.93%) 
Vascular disorders       
HYPERTENSION † 1  15/267 (5.62%)  15/248 (6.05%)  23/253 (9.09%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
[Not Specified]
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boaz Hirschberg
Organization: AstraZeneca Pharmaceuticals
EMail: ClinicalTrialTransparency@astrazeneca.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313313    
Other Study ID Numbers: CV181-040
First Submitted: April 10, 2006
First Posted: April 12, 2006
Results First Submitted: August 17, 2009
Results First Posted: September 25, 2009
Last Update Posted: May 4, 2015