Trial Outcomes & Findings for A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas (NCT NCT00313313)
NCT ID: NCT00313313
Last Updated: 2015-05-04
Results Overview
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
768 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Placebo + Glyburide 7.5 mg
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.
|
Saxagliptin 2.5 mg + Glyburide 7.5 mg
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
267
|
248
|
253
|
|
Overall Study
COMPLETED
|
185
|
185
|
187
|
|
Overall Study
NOT COMPLETED
|
82
|
63
|
66
|
Reasons for withdrawal
| Measure |
Placebo + Glyburide 7.5 mg
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.
|
Saxagliptin 2.5 mg + Glyburide 7.5 mg
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
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.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
20
|
14
|
9
|
|
Overall Study
Withdrawal of consent by subject
|
31
|
18
|
17
|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
7
|
|
Overall Study
Adverse Event
|
12
|
15
|
16
|
|
Overall Study
Physician Decision
|
4
|
2
|
6
|
|
Overall Study
Poor/Noncompliance
|
2
|
3
|
6
|
|
Overall Study
Pregnancy
|
0
|
1
|
2
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Subject No Longer Meets Study Criteria
|
2
|
0
|
3
|
Baseline Characteristics
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Baseline characteristics by cohort
| Measure |
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=248 Participants
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=253 Participants
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.
|
Placebo + Glyburide 7.5 mg
n=267 Participants
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
n=768 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.36 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
54.85 years
STANDARD_DEVIATION 9.96 • n=7 Participants
|
55.06 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
55.09 years
STANDARD_DEVIATION 10.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: 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.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=246 Participants
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=250 Participants
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.
|
Placebo + Glyburide 7.5 mg
n=264 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Adjusted Mean Change from Baseline
|
-0.54 percent
Standard Error 0.059
|
-0.64 percent
Standard Error 0.059
|
0.08 percent
Standard Error 0.057
|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Baseline Mean
|
8.36 percent
Standard Error 0.057
|
8.48 percent
Standard Error 0.056
|
8.44 percent
Standard Error 0.055
|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Week 24 Mean
|
7.83 percent
Standard Error 0.074
|
7.83 percent
Standard Error 0.074
|
8.52 percent
Standard Error 0.077
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=247 Participants
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=252 Participants
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.
|
Placebo + Glyburide 7.5 mg
n=265 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline Mean
|
170.1 mg/dL
Standard Error 2.67
|
175.0 mg/dL
Standard Error 2.79
|
174.4 mg/dL
Standard Error 2.64
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Week 24 Mean
|
164.4 mg/dL
Standard Error 2.76
|
164.6 mg/dL
Standard Error 2.76
|
174.6 mg/dL
Standard Error 2.93
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Adjusted Mean Change from Baseline
|
-7.1 mg/dL
Standard Error 2.42
|
-9.7 mg/dL
Standard Error 2.39
|
0.7 mg/dL
Standard Error 2.33
|
SECONDARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=246 Participants
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=250 Participants
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.
|
Placebo + Glyburide 7.5 mg
n=264 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Achieving A1C < 7% at Week 24
|
22.4 Percentage of participants
|
22.8 Percentage of participants
|
9.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=190 Participants
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=195 Participants
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.
|
Placebo + Glyburide 7.5 mg
n=204 Participants
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.
|
|---|---|---|---|
|
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Baseline Mean
|
49124 mg*min/dL
Standard Error 677.2
|
50342 mg*min/dL
Standard Error 669.0
|
51801 mg*min/dL
Standard Error 656.9
|
|
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Week 24 Mean
|
45402 mg*min/dL
Standard Error 681.5
|
45391 mg*min/dL
Standard Error 699.3
|
52416 mg*min/dL
Standard Error 703.7
|
|
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Adjusted Mean Change from Baseline
|
-4296 mg*min/dL
Standard Error 595.0
|
-5000 mg*min/dL
Standard Error 585.5
|
1196 mg*min/dL
Standard Error 574.5
|
Adverse Events
Placebo + Glyburide 7.5 mg
Serious events: 23 serious events
Other events: 163 other events
Deaths: 0 deaths
Saxagliptin 2.5 mg + Glyburide 7.5 mg
Serious events: 18 serious events
Other events: 144 other events
Deaths: 0 deaths
Saxagliptin 5 mg + Glyburide 7.5 mg
Serious events: 12 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Glyburide 7.5 mg
n=267 participants at risk
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.
|
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=248 participants at risk
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=253 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/267
|
0.81%
2/248
|
0.00%
0/253
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.37%
1/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.75%
2/267
|
0.40%
1/248
|
0.40%
1/253
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Vascular disorders
EXTREMITY NECROSIS
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/267
|
0.00%
0/248
|
0.79%
2/253
|
|
Nervous system disorders
SYNCOPE
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.37%
1/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Gastrointestinal disorders
SALIVARY GLAND MASS
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/267
|
0.40%
1/248
|
0.40%
1/253
|
|
Infections and infestations
PNEUMONIA
|
1.1%
3/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/267
|
0.81%
2/248
|
0.00%
0/253
|
|
Infections and infestations
PYELONEPHRITIS
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Infections and infestations
WOUND INFECTION
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Infections and infestations
CELLULITIS ORBITAL
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
1.1%
3/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/267
|
0.40%
1/248
|
0.40%
1/253
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL INJURY
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
General disorders
ASTHENIA
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
General disorders
CHEST PAIN
|
0.00%
0/267
|
0.81%
2/248
|
0.00%
0/253
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOMA BENIGN
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/267
|
0.40%
1/248
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.37%
1/267
|
0.00%
0/248
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/267
|
0.00%
0/248
|
0.40%
1/253
|
Other adverse events
| Measure |
Placebo + Glyburide 7.5 mg
n=267 participants at risk
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.
|
Saxagliptin 2.5 mg + Glyburide 7.5 mg
n=248 participants at risk
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.
|
Saxagliptin 5 mg + Glyburide 7.5 mg
n=253 participants at risk
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.
|
|---|---|---|---|
|
Vascular disorders
HYPERTENSION
|
5.6%
15/267
|
6.0%
15/248
|
9.1%
23/253
|
|
Nervous system disorders
HEADACHE
|
8.6%
23/267
|
9.3%
23/248
|
9.9%
25/253
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.1%
27/267
|
8.9%
22/248
|
6.3%
16/253
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.0%
8/267
|
5.2%
13/248
|
4.0%
10/253
|
|
Gastrointestinal disorders
GASTRITIS
|
3.4%
9/267
|
5.2%
13/248
|
3.2%
8/253
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.2%
6/267
|
6.5%
16/248
|
2.8%
7/253
|
|
Infections and infestations
INFLUENZA
|
10.1%
27/267
|
8.5%
21/248
|
7.5%
19/253
|
|
Infections and infestations
PHARYNGITIS
|
5.6%
15/267
|
4.4%
11/248
|
7.5%
19/253
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.9%
29/267
|
8.5%
21/248
|
10.3%
26/253
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
4.1%
11/267
|
5.2%
13/248
|
2.0%
5/253
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.0%
32/267
|
13.3%
33/248
|
16.6%
42/253
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
25/267
|
6.9%
17/248
|
9.5%
24/253
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
4.5%
12/267
|
4.4%
11/248
|
5.1%
13/253
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.7%
18/267
|
7.3%
18/248
|
6.3%
16/253
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.5%
20/267
|
7.3%
18/248
|
7.9%
20/253
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.1%
19/267
|
5.6%
14/248
|
5.9%
15/253
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.4%
17/267
|
7.7%
19/248
|
5.9%
15/253
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER