Trial Outcomes & Findings for Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise (NCT NCT00316082)
NCT ID: NCT00316082
Last Updated: 2015-04-29
Results Overview
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
365 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2015-04-29
Participant Flow
Participant milestones
| Measure |
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
|
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
71
|
72
|
74
|
|
Overall Study
Completed Study Without Being Rescued
|
25
|
35
|
29
|
27
|
31
|
|
Overall Study
COMPLETED
|
41
|
52
|
44
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
33
|
22
|
27
|
26
|
26
|
Reasons for withdrawal
| Measure |
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
|
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
3
|
4
|
6
|
|
Overall Study
Withdrawal of Consent by Subject
|
10
|
8
|
2
|
9
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
7
|
8
|
6
|
|
Overall Study
Poor/noncompliance
|
6
|
1
|
4
|
1
|
4
|
|
Overall Study
Adverse Event
|
4
|
2
|
5
|
1
|
3
|
|
Overall Study
Subject no longer meets study criteria
|
3
|
1
|
2
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Baseline characteristics by cohort
| Measure |
Saxagliptin 2.5 mg Once in the Morning (QAM)
n=74 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=74 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
n=71 Participants
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Saxagliptin 5 mg Once in the Evening (QPM)
n=72 Participants
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
|
Placebo
n=74 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.24 years
STANDARD_DEVIATION 10.44 • n=99 Participants
|
54.66 years
STANDARD_DEVIATION 9.71 • n=107 Participants
|
54.28 years
STANDARD_DEVIATION 10.93 • n=206 Participants
|
55.11 years
STANDARD_DEVIATION 10.35 • n=7 Participants
|
55.57 years
STANDARD_DEVIATION 10.32 • n=31 Participants
|
54.98 years
STANDARD_DEVIATION 10.31 • n=30 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
197 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
168 Participants
n=30 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 QAM
n=67 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=69 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
n=69 Participants
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Placebo
n=68 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Baseline Mean
|
8.04 percent
Standard Error 0.105
|
7.93 percent
Standard Error 0.106
|
8.02 percent
Standard Error 0.131
|
7.79 percent
Standard Error 0.112
|
—
|
|
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Week 24 Mean
|
7.30 percent
Standard Error 0.106
|
7.27 percent
Standard Error 0.129
|
7.37 percent
Standard Error 0.137
|
7.57 percent
Standard Error 0.141
|
—
|
|
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Adjusted Mean Change from Baseline
|
-0.71 percent
Standard Error 0.103
|
-0.66 percent
Standard Error 0.102
|
-0.63 percent
Standard Error 0.102
|
-0.26 percent
Standard Error 0.103
|
—
|
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 A1C at Week 24, adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 2.5 mg QAM
n=70 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=68 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Baseline Mean
|
7.88 percent
Standard Error 0.111
|
7.79 percent
Standard Error 0.112
|
—
|
—
|
—
|
|
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Week 24 Mean
|
7.29 percent
Standard Error 0.124
|
7.57 percent
Standard Error 0.141
|
—
|
—
|
—
|
|
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Adjusted Mean Change from Baseline
|
-0.61 percent
Standard Error 0.101
|
-0.26 percent
Standard Error 0.103
|
—
|
—
|
—
|
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 QAM
n=70 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=71 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
n=71 Participants
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Placebo
n=71 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Placebo
n=71 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Week 24 Mean
|
146.8 mg/dL
Standard Error 3.79
|
151.3 mg/dL
Standard Error 5.88
|
155.2 mg/dL
Standard Error 5.88
|
152.4 mg/dL
Standard Error 5.88
|
162.9 mg/dL
Standard Error 6.28
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline Mean
|
156.6 mg/dL
Standard Error 3.96
|
162.2 mg/dL
Standard Error 4.24
|
170.6 mg/dL
Standard Error 6.15
|
159.6 mg/dL
Standard Error 5.32
|
158.6 mg/dL
Standard Error 5.44
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Adjusted Mean Change from Baseline
|
-11.4 mg/dL
Standard Error 4.50
|
-10.7 mg/dL
Standard Error 4.46
|
-12.5 mg/dL
Standard Error 4.48
|
-7.9 mg/dL
Standard Error 4.46
|
3.3 mg/dL
Standard Error 4.46
|
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 versus placebo at Week 24.
Outcome measures
| Measure |
Saxagliptin 2.5 mg QAM
n=67 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=69 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
n=69 Participants
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Placebo
n=70 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Placebo
n=68 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving A1C < 7% at Week 24
|
35.8 Percentage of participants
|
44.9 Percentage of participants
|
43.5 Percentage of participants
|
38.6 Percentage of participants
|
35.3 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 value.
Outcome measures
| Measure |
Saxagliptin 2.5 mg QAM
n=48 Participants
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=48 Participants
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 2.5/5 mg QAM
n=47 Participants
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Placebo
n=43 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Placebo
n=47 Participants
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
|---|---|---|---|---|---|
|
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
|
-8014 mg*min/dL
Standard Error 1246.9
|
-8218 mg*min/dL
Standard Error 1249.1
|
-7781 mg*min/dL
Standard Error 1261.0
|
-6048 mg*min/dL
Standard Error 1318.2
|
-3088 mg*min/dL
Standard Error 1259.7
|
|
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
|
47432 mg*min/dL
Standard Error 1496.6
|
50417 mg*min/dL
Standard Error 1561.5
|
50032 mg*min/dL
Standard Error 1684.7
|
47078 mg*min/dL
Standard Error 1941.9
|
47640 mg*min/dL
Standard Error 1759.7
|
|
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
|
39798 mg*min/dL
Standard Error 1347.0
|
41562 mg*min/dL
Standard Error 1489.3
|
41745 mg*min/dL
Standard Error 1739.2
|
41530 mg*min/dL
Standard Error 1962.7
|
44861 mg*min/dL
Standard Error 1854.7
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Saxagliptin 2.5/5 mg QAM
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Saxagliptin 2.5 mg QAM
Serious events: 7 serious events
Other events: 32 other events
Deaths: 0 deaths
Saxagliptin 5 mg QAM
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Saxagliptin 5 mg QPM
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=74 participants at risk
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Saxagliptin 2.5/5 mg QAM
n=71 participants at risk
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Saxagliptin 2.5 mg QAM
n=74 participants at risk
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=74 participants at risk
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QPM
n=72 participants at risk
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
|
|---|---|---|---|---|---|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Cardiac disorders
COR PULMONALE ACUTE
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.7%
2/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Vascular disorders
ARTERIAL DISORDER
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
2.8%
2/72
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.4%
1/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Gastrointestinal disorders
RECTAL POLYP
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
1.4%
1/72
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
1.4%
1/72
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
1.4%
1/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.4%
1/74
|
0.00%
0/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.00%
0/74
|
0.00%
0/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/74
|
0.00%
0/71
|
2.7%
2/74
|
0.00%
0/74
|
1.4%
1/72
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
General disorders
CHEST PAIN
|
0.00%
0/74
|
1.4%
1/71
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER METASTATIC
|
0.00%
0/74
|
1.4%
1/71
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/72
|
Other adverse events
| Measure |
Placebo
n=74 participants at risk
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
|
Saxagliptin 2.5/5 mg QAM
n=71 participants at risk
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
|
Saxagliptin 2.5 mg QAM
n=74 participants at risk
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QAM
n=74 participants at risk
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
|
Saxagliptin 5 mg QPM
n=72 participants at risk
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
|
|---|---|---|---|---|---|
|
Vascular disorders
HYPERTENSION
|
1.4%
1/74
|
5.6%
4/71
|
4.1%
3/74
|
4.1%
3/74
|
0.00%
0/72
|
|
Nervous system disorders
HEADACHE
|
4.1%
3/74
|
2.8%
2/71
|
5.4%
4/74
|
6.8%
5/74
|
2.8%
2/72
|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
1/74
|
5.6%
4/71
|
5.4%
4/74
|
2.7%
2/74
|
4.2%
3/72
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.4%
1/74
|
1.4%
1/71
|
9.5%
7/74
|
5.4%
4/74
|
5.6%
4/72
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/74
|
5.6%
4/71
|
4.1%
3/74
|
2.7%
2/74
|
0.00%
0/72
|
|
Infections and infestations
RHINITIS
|
1.4%
1/74
|
5.6%
4/71
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/72
|
|
Infections and infestations
SINUSITIS
|
4.1%
3/74
|
7.0%
5/71
|
6.8%
5/74
|
4.1%
3/74
|
0.00%
0/72
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/74
|
4.2%
3/71
|
1.4%
1/74
|
6.8%
5/74
|
1.4%
1/72
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.1%
3/74
|
4.2%
3/71
|
4.1%
3/74
|
5.4%
4/74
|
6.9%
5/72
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.7%
2/74
|
4.2%
3/71
|
5.4%
4/74
|
4.1%
3/74
|
5.6%
4/72
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.5%
7/74
|
15.5%
11/71
|
14.9%
11/74
|
13.5%
10/74
|
15.3%
11/72
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/74
|
0.00%
0/71
|
0.00%
0/74
|
5.4%
4/74
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.1%
3/74
|
5.6%
4/71
|
4.1%
3/74
|
6.8%
5/74
|
2.8%
2/72
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.1%
3/74
|
5.6%
4/71
|
2.7%
2/74
|
1.4%
1/74
|
6.9%
5/72
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.4%
1/74
|
7.0%
5/71
|
2.7%
2/74
|
4.1%
3/74
|
6.9%
5/72
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.7%
2/74
|
4.2%
3/71
|
4.1%
3/74
|
5.4%
4/74
|
2.8%
2/72
|
|
General disorders
ASTHENIA
|
4.1%
3/74
|
5.6%
4/71
|
0.00%
0/74
|
1.4%
1/74
|
2.8%
2/72
|
|
General disorders
OEDEMA PERIPHERAL
|
4.1%
3/74
|
2.8%
2/71
|
6.8%
5/74
|
2.7%
2/74
|
1.4%
1/72
|
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