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52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

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: NCT00575588
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 6, 2010
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Metformin
Drug: Sulphonylurea
Drug: Saxagliptin
Enrollment 891
Recruitment Details  
Pre-assignment Details 891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description Saxagliptin 5 mg tablets added on to open-label metformin Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Period Title: Overall Study
Started 428 [1] 430 [1]
Completed 165 [2] 147 [2]
Not Completed 263 283
Reason Not Completed
Adverse Event             11             13
Withdrawal by Subject             27             31
Lost to Follow-up             1             3
Death             4             2
Incorrect enrollment             8             4
Study specific discontinuation criteria             203             218
Severe non-compliance to protocol             5             7
Safety reasons             2             1
Elevated triglyceride             1             0
Patient moved             1             3
Impossible to determine HbA1c             0             1
[1]
Randomized and treated
[2]
Completed 104 weeks of treatment
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin Total
Hide Arm/Group Description Saxagliptin 5 mg tablets added on to open-label metformin Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin Total of all reporting groups
Overall Number of Baseline Participants 428 430 858
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 428 participants 430 participants 858 participants
57.50  (10.26) 57.59  (10.37) 57.55  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 430 participants 858 participants
Female
216
  50.5%
198
  46.0%
414
  48.3%
Male
212
  49.5%
232
  54.0%
444
  51.7%
1.Primary Outcome
Title Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Hide Description Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Time Frame Baseline to 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 293 293
Mean (Standard Error)
Unit of Measure: Percent
Baseline 7.46  (0.045) 7.53  (0.045)
Week 52 6.74  (0.042) 6.71  (0.042)
Adjusted Change from Baseline to Week 52 -0.74  (0.038) -0.80  (0.038)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.05 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.053
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Hide Description Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 428 430
Measure Type: Number
Unit of Measure: Percentage of Participants
3 36.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between group comparison significant after controlling overall alpha of the study
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -33.2
Confidence Interval (2-Sided) 95%
-38.1 to -28.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Body Weight Change From Baseline to Week 52
Hide Description Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Time Frame Baseline, Week 52 (Last Observation Carried Forward)
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 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 424 426
Mean (Standard Error)
Unit of Measure: kilogram
Baseline 88.7  (0.91) 88.6  (0.95)
Week 52 87.6  (0.90) 89.7  (0.99)
Adjusted Change from Baseline to Week 52 -1.1  (0.17) 1.1  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between group comparison significant after controlling overall alpha of the study
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.2
Confidence Interval 95%
-2.7 to -1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Hide Description Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Time Frame Week 24 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 289 293
Mean (Standard Error)
Unit of Measure: Percent
0.001  (0.001) 0.004  (0.001)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Between group comparison significant after controlling overall alpha of the study
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.002
Confidence Interval (2-Sided) 95%
-0.0046 to -0.0001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.001
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Hide Description Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 423 423
Mean (Standard Error)
Unit of Measure: Percent
Baseline 7.65  (0.044) 7.65  (0.041)
Week 104 7.27  (0.050) 7.27  (0.046)
Adjusted Change from Baseline to Week 104 -0.41  (0.041) -0.35  (0.043)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.17 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.059
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
Hide Description Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)
Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 428 430
Measure Type: Number
Unit of Measure: Percentage of Participants
3.5 38.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -34.9
Confidence Interval (2-Sided) 95%
-39.8 to -30.0
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Body Weight Change From Baseline to Week 104
Hide Description Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 424 426
Mean (Standard Error)
Unit of Measure: kilograms
Baseline 88.69  (0.905) 88.57  (0.955)
Week 104 87.47  (0.898) 89.80  (0.987)
Adjusted Change from Baseline to Week 104 -1.47  (0.200) 1.29  (0.205)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.76
Confidence Interval (2-Sided) 95%
-3.32 to -2.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.286
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c
Hide Description Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Time Frame Week 24 to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description:
Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Overall Number of Participants Analyzed 373 377
Mean (Standard Error)
Unit of Measure: Percent
0.0041  (0.0005) 0.0076  (0.0005)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin + Metformin, Glipizide + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0035
Confidence Interval (2-Sided) 95%
-0.0048 to -0.0022
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0007
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saxagliptin + Metformin Glipizide + Metformin
Hide Arm/Group Description Saxagliptin 5 mg tablets added on to open-label metformin Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
All-Cause Mortality
Saxagliptin + Metformin Glipizide + Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Saxagliptin + Metformin Glipizide + Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   54/428 (12.62%)   55/430 (12.79%) 
Cardiac disorders     
Atrial Fibrillation † 1  2/428 (0.47%)  2/430 (0.47%) 
Coronary Artery Disease † 1  2/428 (0.47%)  1/430 (0.23%) 
Angina Pectoris † 1  1/428 (0.23%)  0/430 (0.00%) 
Atrioventricular Block Complete † 1  1/428 (0.23%)  0/430 (0.00%) 
Cardiac Failure † 1  1/428 (0.23%)  1/430 (0.23%) 
Coronary Artery Stenosis † 1  1/428 (0.23%)  0/430 (0.00%) 
Myocardial Infarction † 1  1/428 (0.23%)  1/430 (0.23%) 
Myocardial Ischemia † 1  1/428 (0.23%)  0/430 (0.00%) 
Supraventricular Tachycardia † 1  1/428 (0.23%)  0/430 (0.00%) 
Ventricular Fibrillation † 1  1/428 (0.23%)  0/430 (0.00%) 
Angina Unstable † 1  0/428 (0.00%)  2/430 (0.47%) 
Arteriosclerosis Coronary Artery † 1  0/428 (0.00%)  1/430 (0.23%) 
Bradycardia † 1  0/428 (0.00%)  1/430 (0.23%) 
Coronary Artery Occlusion † 1  0/428 (0.00%)  1/430 (0.23%) 
Arrhythmia † 1  1/428 (0.23%)  0/430 (0.00%) 
Congenital, familial and genetic disorders     
Hydrocele † 1  1/428 (0.23%)  0/430 (0.00%) 
Ear and labyrinth disorders     
Deafness Bilateral † 1  1/428 (0.23%)  0/430 (0.00%) 
Vertigo † 1  0/428 (0.00%)  1/430 (0.23%) 
Endocrine disorders     
Hyperthyroidism † 1  0/428 (0.00%)  1/430 (0.23%) 
Eye disorders     
Cataract † 1  2/428 (0.47%)  0/430 (0.00%) 
Retinal Vein Occlusion † 1  0/428 (0.00%)  1/430 (0.23%) 
Gastrointestinal disorders     
Inguinal Hernia † 1  1/428 (0.23%)  1/430 (0.23%) 
Abdominal Pain † 1  0/428 (0.00%)  1/430 (0.23%) 
Acute Abdomen † 1  0/428 (0.00%)  1/430 (0.23%) 
Gastroesophageal Reflux Disease † 1  0/428 (0.00%)  2/430 (0.47%) 
Pancreatitis † 1  0/428 (0.00%)  1/430 (0.23%) 
Pancreatitis Acute † 1  0/428 (0.00%)  1/430 (0.23%) 
Abdominal Pain Upper † 1  1/428 (0.23%)  0/430 (0.00%) 
Food Poisoning † 1  1/428 (0.23%)  0/430 (0.00%) 
Gastric Ulcer † 1  1/428 (0.23%)  0/430 (0.00%) 
Rectal Hemorrhage † 1  1/428 (0.23%)  1/430 (0.23%) 
Upper Gastrointestinal Hemorrhage † 1  1/428 (0.23%)  0/430 (0.00%) 
Gastric Hemorrhage † 1  0/428 (0.00%)  1/430 (0.23%) 
General disorders     
Chest Pain † 1  1/428 (0.23%)  1/430 (0.23%) 
Device Malfunction † 1  1/428 (0.23%)  0/430 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute † 1  0/428 (0.00%)  1/430 (0.23%) 
Biliary Colic † 1  0/428 (0.00%)  1/430 (0.23%) 
Hepatitis † 1  0/428 (0.00%)  1/430 (0.23%) 
Cholelithiasis † 1  1/428 (0.23%)  1/430 (0.23%) 
Cholecystitis † 1  0/428 (0.00%)  1/430 (0.23%) 
Immune system disorders     
Allergy To Arthropod Sting † 1  1/428 (0.23%)  0/430 (0.00%) 
Hypersensitivity † 1  1/428 (0.23%)  1/430 (0.23%) 
Infections and infestations     
Anal Abscess † 1  1/428 (0.23%)  0/430 (0.00%) 
Pneumonia † 1  2/428 (0.47%)  1/430 (0.23%) 
Pulmonary Tuberculosis † 1  1/428 (0.23%)  0/430 (0.00%) 
Pyelonephritis † 1  1/428 (0.23%)  0/430 (0.00%) 
Helicobacter Gastritis † 1  0/428 (0.00%)  1/430 (0.23%) 
Superinfection † 1  0/428 (0.00%)  1/430 (0.23%) 
Herpes Zoster Ophthalmic † 1  1/428 (0.23%)  0/430 (0.00%) 
Salmonella Sepsis † 1  1/428 (0.23%)  0/430 (0.00%) 
Urosepsis † 1  1/428 (0.23%)  0/430 (0.00%) 
Biliary Tract Infection † 1  0/428 (0.00%)  1/420 (0.24%) 
Injury, poisoning and procedural complications     
Femoral Neck Fracture † 1  1/428 (0.23%)  0/430 (0.00%) 
Head Injury † 1  1/428 (0.23%)  0/430 (0.00%) 
Meniscus Lesion † 1  1/428 (0.23%)  0/430 (0.00%) 
Concussion † 1  0/428 (0.00%)  1/430 (0.23%) 
Femur Fracture † 1  0/428 (0.00%)  1/430 (0.23%) 
Ligament Rupture † 1  0/428 (0.00%)  1/430 (0.23%) 
Open Wound † 1  0/428 (0.00%)  1/430 (0.23%) 
Tendon Rupture † 1  0/428 (0.00%)  1/430 (0.23%) 
Contusion † 1  1/428 (0.23%)  0/430 (0.00%) 
Lumbar Vertebral Fracture † 1  1/428 (0.23%)  0/430 (0.00%) 
Patella Fracture † 1  1/428 (0.23%)  0/430 (0.00%) 
Upper Limb Fracture † 1  1/428 (0.23%)  0/430 (0.00%) 
Humerus Fracture † 1  0/428 (0.00%)  1/430 (0.23%) 
Injury † 1  0/428 (0.00%)  1/430 (0.23%) 
Metabolism and nutrition disorders     
Diabetes Mellitus † 1  0/428 (0.00%)  1/430 (0.23%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis † 1  2/428 (0.47%)  1/430 (0.23%) 
Arthritis † 1  1/428 (0.23%)  0/430 (0.00%) 
Arthropathy † 1  1/428 (0.23%)  0/430 (0.00%) 
Intervertebral Disc Protrusion † 1  1/428 (0.23%)  0/430 (0.00%) 
Jaw Cyst † 1  1/428 (0.23%)  0/430 (0.00%) 
Osteochondrosis † 1  1/428 (0.23%)  1/430 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer † 1  1/428 (0.23%)  0/430 (0.00%) 
Colon Cancer † 1  2/428 (0.47%)  0/430 (0.00%) 
Metastasis To Liver † 1  1/428 (0.23%)  0/430 (0.00%) 
Salivary Gland Neoplasm † 1  1/428 (0.23%)  0/430 (0.00%) 
Acute Myeloid Leukemia † 1  1/428 (0.23%)  0/430 (0.00%) 
Metastases to Central Nervous System † 1  1/428 (0.23%)  0/430 (0.00%) 
Thyroid Cancer † 1  1/428 (0.23%)  0/430 (0.00%) 
Bladder Neoplasm † 1  0/428 (0.00%)  1/430 (0.23%) 
Bronchial Carcinoma † 1  0/428 (0.00%)  1/430 (0.23%) 
Colon Neoplasm † 1  0/428 (0.00%)  1/430 (0.23%) 
Lip Neoplasm Malignant Stage Unspecified † 1  0/428 (0.00%)  1/430 (0.23%) 
Lung Neoplasm malignant † 1  0/428 (0.00%)  1/430 (0.23%) 
Malignant Melanoma † 1  0/428 (0.00%)  1/430 (0.23%) 
Renal Cancer † 1  0/428 (0.00%)  1/430 (0.23%) 
Tumor Ulceration † 1  0/428 (0.00%)  1/430 (0.23%) 
Breast Cancer † 1  0/428 (0.00%)  1/430 (0.23%) 
Nervous system disorders     
Cerebrovascular Disorder † 1  1/428 (0.23%)  0/430 (0.00%) 
Cerebral Ischemia † 1  0/428 (0.00%)  1/430 (0.23%) 
Cerebrovascular Accident † 1  1/428 (0.23%)  1/430 (0.23%) 
Ischemic Stroke † 1  0/428 (0.00%)  1/430 (0.23%) 
Epilepsy † 1  1/428 (0.23%)  0/430 (0.00%) 
Hypertensive Encephalopathy † 1  1/428 (0.23%)  0/430 (0.00%) 
Vertebrobasilar Insufficiency † 1  1/428 (0.23%)  0/430 (0.00%) 
Headache † 1  0/428 (0.00%)  1/430 (0.23%) 
Transient Ischemic Attack † 1  0/428 (0.00%)  1/430 (0.23%) 
Psychiatric disorders     
Agitation † 1  0/428 (0.00%)  1/430 (0.23%) 
Renal and urinary disorders     
Renal Failure Acute † 1  1/428 (0.23%)  0/430 (0.00%) 
Urinary Retention † 1  0/428 (0.00%)  1/430 (0.23%) 
Nephrolithiasis † 1  1/428 (0.23%)  0/430 (0.00%) 
Reproductive system and breast disorders     
Endometrial Hyperplasia † 1  1/428 (0.23%)  0/430 (0.00%) 
Benign Prostatic Hyperplasia † 1  0/428 (0.00%)  1/430 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/428 (0.23%)  0/430 (0.00%) 
Bronchitis Chronic † 1  1/428 (0.23%)  0/430 (0.00%) 
Dyspnea † 1  0/428 (0.00%)  1/430 (0.23%) 
Laryngeal Edema † 1  0/428 (0.00%)  1/430 (0.23%) 
Pulmonary Embolism † 1  0/428 (0.00%)  1/430 (0.23%) 
Vascular disorders     
Aortic Aneurysm † 1  1/428 (0.23%)  0/430 (0.00%) 
Hypertension † 1  0/428 (0.00%)  3/430 (0.70%) 
Hypotension † 1  0/428 (0.00%)  1/430 (0.23%) 
Arteriosclerosis † 1  0/428 (0.00%)  1/430 (0.23%) 
Hypertensive Crisis † 1  0/428 (0.00%)  3/430 (0.70%) 
Circulatory Collapse † 1  0/428 (0.00%)  1/430 (0.23%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Saxagliptin + Metformin Glipizide + Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   105/428 (24.53%)   201/430 (46.74%) 
Gastrointestinal disorders     
Diarrhoea † 1  25/428 (5.84%)  17/430 (3.95%) 
Infections and infestations     
Nasopharyngitis † 1  46/428 (10.75%)  41/430 (9.53%) 
Upper Respiratory Tract Infection † 1  25/428 (5.84%)  16/430 (3.72%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1  15/428 (3.50%)  165/430 (38.37%) 
Vascular disorders     
Hypertension † 1  19/428 (4.44%)  27/430 (6.28%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00575588    
Other Study ID Numbers: D1680C00001
EudraCT number 2007-003998-55
First Submitted: December 14, 2007
First Posted: December 18, 2007
Results First Submitted: August 10, 2010
Results First Posted: September 6, 2010
Last Update Posted: March 21, 2012