Trial Outcomes & Findings for 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period (NCT NCT00575588)
NCT ID: NCT00575588
Last Updated: 2012-03-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
891 participants
Primary outcome timeframe
Baseline to 52 Weeks
Results posted on
2012-03-21
Participant Flow
891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.
Participant milestones
| Measure |
Saxagliptin + Metformin
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Overall Study
STARTED
|
428
|
430
|
|
Overall Study
COMPLETED
|
165
|
147
|
|
Overall Study
NOT COMPLETED
|
263
|
283
|
Reasons for withdrawal
| Measure |
Saxagliptin + Metformin
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
13
|
|
Overall Study
Withdrawal by Subject
|
27
|
31
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Incorrect enrollment
|
8
|
4
|
|
Overall Study
Study specific discontinuation criteria
|
203
|
218
|
|
Overall Study
Severe non-compliance to protocol
|
5
|
7
|
|
Overall Study
Safety reasons
|
2
|
1
|
|
Overall Study
Elevated triglyceride
|
1
|
0
|
|
Overall Study
Patient moved
|
1
|
3
|
|
Overall Study
Impossible to determine HbA1c
|
0
|
1
|
Baseline Characteristics
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Baseline characteristics by cohort
| Measure |
Saxagliptin + Metformin
n=428 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=430 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
Total
n=858 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.50 years
STANDARD_DEVIATION 10.26 • n=5 Participants
|
57.59 years
STANDARD_DEVIATION 10.37 • n=7 Participants
|
57.55 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 WeeksPopulation: Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations
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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=293 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=293 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Baseline
|
7.46 Percent
Standard Error 0.045
|
7.53 Percent
Standard Error 0.045
|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Week 52
|
6.74 Percent
Standard Error 0.042
|
6.71 Percent
Standard Error 0.042
|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Adjusted Change from Baseline to Week 52
|
-0.74 Percent
Standard Error 0.038
|
-0.80 Percent
Standard Error 0.038
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Proportion 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)
Outcome measures
| Measure |
Saxagliptin + Metformin
n=428 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=430 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
|
3 Percentage of Participants
Interval -38.1 to -28.5
|
36.3 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (Last Observation Carried Forward)Population: 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
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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=424 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=426 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Body Weight Change From Baseline to Week 52
Baseline
|
88.7 kilogram
Standard Error 0.91
|
88.6 kilogram
Standard Error 0.95
|
|
Body Weight Change From Baseline to Week 52
Week 52
|
87.6 kilogram
Standard Error 0.90
|
89.7 kilogram
Standard Error 0.99
|
|
Body Weight Change From Baseline to Week 52
Adjusted Change from Baseline to Week 52
|
-1.1 kilogram
Standard Error 0.17
|
1.1 kilogram
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations
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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=289 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=293 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
|
0.001 Percent
Standard Error 0.001
|
0.004 Percent
Standard Error 0.001
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104Population: Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin
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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=423 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=423 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Baseline
|
7.65 Percent
Standard Error 0.044
|
7.65 Percent
Standard Error 0.041
|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Week 104
|
7.27 Percent
Standard Error 0.050
|
7.27 Percent
Standard Error 0.046
|
|
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Adjusted Change from Baseline to Week 104
|
-0.41 Percent
Standard Error 0.041
|
-0.35 Percent
Standard Error 0.043
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104Proportion 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)
Outcome measures
| Measure |
Saxagliptin + Metformin
n=428 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=430 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
|
3.5 Percentage of Participants
|
38.4 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104Population: Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin
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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=424 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=426 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Body Weight Change From Baseline to Week 104
Baseline
|
88.69 kilograms
Standard Error 0.905
|
88.57 kilograms
Standard Error 0.955
|
|
Body Weight Change From Baseline to Week 104
Week 104
|
87.47 kilograms
Standard Error 0.898
|
89.80 kilograms
Standard Error 0.987
|
|
Body Weight Change From Baseline to Week 104
Adjusted Change from Baseline to Week 104
|
-1.47 kilograms
Standard Error 0.200
|
1.29 kilograms
Standard Error 0.205
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24 to Week 104Mean 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.
Outcome measures
| Measure |
Saxagliptin + Metformin
n=373 Participants
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=377 Participants
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c
|
0.0041 Percent
Standard Error 0.0005
|
0.0076 Percent
Standard Error 0.0005
|
Adverse Events
Saxagliptin + Metformin
Serious events: 54 serious events
Other events: 105 other events
Deaths: 0 deaths
Glipizide + Metformin
Serious events: 55 serious events
Other events: 201 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saxagliptin + Metformin
n=428 participants at risk
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=430 participants at risk
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.47%
2/428
|
0.47%
2/430
|
|
Cardiac disorders
Coronary Artery Disease
|
0.47%
2/428
|
0.23%
1/430
|
|
Cardiac disorders
Angina Pectoris
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Cardiac Failure
|
0.23%
1/428
|
0.23%
1/430
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/428
|
0.23%
1/430
|
|
Cardiac disorders
Myocardial Ischemia
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.23%
1/428
|
0.00%
0/430
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/428
|
0.47%
2/430
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/428
|
0.23%
1/430
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/428
|
0.23%
1/430
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/428
|
0.23%
1/430
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
2/428
|
0.23%
1/430
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.23%
1/428
|
0.00%
0/430
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.23%
1/428
|
0.00%
0/430
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.23%
1/428
|
0.00%
0/430
|
|
Musculoskeletal and connective tissue disorders
Jaw Cyst
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Anal Abscess
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Pneumonia
|
0.47%
2/428
|
0.23%
1/430
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Pyelonephritis
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/428
|
0.23%
1/430
|
|
Infections and infestations
Superinfection
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.23%
1/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.47%
2/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis To Liver
|
0.23%
1/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Neoplasm
|
0.23%
1/428
|
0.00%
0/430
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.23%
1/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/428
|
0.47%
2/430
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/428
|
0.23%
1/430
|
|
Immune system disorders
Allergy To Arthropod Sting
|
0.23%
1/428
|
0.00%
0/430
|
|
Immune system disorders
Hypersensitivity
|
0.23%
1/428
|
0.23%
1/430
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/428
|
0.00%
0/430
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.23%
1/428
|
0.00%
0/430
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/428
|
0.23%
1/430
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
0.00%
0/428
|
0.23%
1/430
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/428
|
0.23%
1/430
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.23%
1/428
|
0.00%
0/430
|
|
Ear and labyrinth disorders
Deafness Bilateral
|
0.23%
1/428
|
0.00%
0/430
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/428
|
0.23%
1/430
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/428
|
0.23%
1/430
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/428
|
0.23%
1/430
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/428
|
0.23%
1/430
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.23%
1/428
|
0.00%
0/430
|
|
Nervous system disorders
Cerebral Ischemia
|
0.00%
0/428
|
0.23%
1/430
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.23%
1/428
|
0.23%
1/430
|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/428
|
0.23%
1/430
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.23%
1/428
|
0.00%
0/430
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/428
|
0.23%
1/430
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.23%
1/428
|
0.00%
0/430
|
|
Vascular disorders
Aortic Aneurysm
|
0.23%
1/428
|
0.00%
0/430
|
|
Vascular disorders
Hypertension
|
0.00%
0/428
|
0.70%
3/430
|
|
Vascular disorders
Hypotension
|
0.00%
0/428
|
0.23%
1/430
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/428
|
0.23%
1/430
|
|
Cardiac disorders
Arrhythmia
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Herpes Zoster Ophthalmic
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Salmonella Sepsis
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Urosepsis
|
0.23%
1/428
|
0.00%
0/430
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/428
|
0.24%
1/420
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
0.23%
1/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.23%
1/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.23%
1/428
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip Neoplasm Malignant Stage Unspecified
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm malignant
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Ulceration
|
0.00%
0/428
|
0.23%
1/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/428
|
0.23%
1/430
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.23%
1/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.23%
1/428
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/428
|
0.23%
1/430
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/428
|
0.23%
1/430
|
|
Nervous system disorders
Epilepsy
|
0.23%
1/428
|
0.00%
0/430
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.23%
1/428
|
0.00%
0/430
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.23%
1/428
|
0.00%
0/430
|
|
Nervous system disorders
Headache
|
0.00%
0/428
|
0.23%
1/430
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.23%
1/428
|
0.00%
0/430
|
|
Gastrointestinal disorders
Food Poisoning
|
0.23%
1/428
|
0.00%
0/430
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.23%
1/428
|
0.00%
0/430
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.23%
1/428
|
0.23%
1/430
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.23%
1/428
|
0.00%
0/430
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/428
|
0.23%
1/430
|
|
Eye disorders
Cataract
|
0.47%
2/428
|
0.00%
0/430
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/428
|
0.23%
1/430
|
|
General disorders
Chest Pain
|
0.23%
1/428
|
0.23%
1/430
|
|
General disorders
Device Malfunction
|
0.23%
1/428
|
0.00%
0/430
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/428
|
0.00%
0/430
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/428
|
0.23%
1/430
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/428
|
0.23%
1/430
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/428
|
0.70%
3/430
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/428
|
0.23%
1/430
|
|
Psychiatric disorders
Agitation
|
0.00%
0/428
|
0.23%
1/430
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/428
|
0.23%
1/430
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/428
|
0.23%
1/430
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/428
|
0.23%
1/430
|
Other adverse events
| Measure |
Saxagliptin + Metformin
n=428 participants at risk
Saxagliptin 5 mg tablets added on to open-label metformin
|
Glipizide + Metformin
n=430 participants at risk
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
25/428
|
4.0%
17/430
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
46/428
|
9.5%
41/430
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.5%
15/428
|
38.4%
165/430
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
25/428
|
3.7%
16/430
|
|
Vascular disorders
Hypertension
|
4.4%
19/428
|
6.3%
27/430
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place