Trial Outcomes & Findings for A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone (NCT NCT00295633)
NCT ID: NCT00295633
Last Updated: 2015-04-07
Results Overview
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
565 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2015-04-07
Participant Flow
Participant milestones
| Measure |
Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
195
|
186
|
184
|
|
Overall Study
Completed Study Without Being Rescued
|
88
|
82
|
51
|
|
Overall Study
COMPLETED
|
133
|
119
|
108
|
|
Overall Study
NOT COMPLETED
|
62
|
67
|
76
|
Reasons for withdrawal
| Measure |
Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
19
|
7
|
16
|
|
Overall Study
Withdrawal of consent by subject
|
16
|
16
|
26
|
|
Overall Study
Adverse Event
|
9
|
17
|
9
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
7
|
|
Overall Study
Physician Decision
|
9
|
10
|
8
|
|
Overall Study
Poor/Noncompliance
|
2
|
2
|
6
|
|
Overall Study
Subject No Longer Meets Study Criteria
|
0
|
3
|
3
|
|
Overall Study
Death
|
1
|
1
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
1
|
Baseline Characteristics
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Baseline characteristics by cohort
| Measure |
Saxagliptin 2.5 mg Plus Open-label TZD
n=195 Participants
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
n=186 Participants
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
n=184 Participants
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.85 years
STANDARD_DEVIATION 9.73 • n=99 Participants
|
53.22 years
STANDARD_DEVIATION 10.56 • n=107 Participants
|
54.01 years
STANDARD_DEVIATION 10.08 • n=206 Participants
|
54.04 years
STANDARD_DEVIATION 10.13 • n=7 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
280 Participants
n=7 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 Plus Open-label TZD
n=192 Participants
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
n=183 Participants
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
n=180 Participants
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Baseline Mean
|
8.25 percent
Standard Error 0.080
|
8.35 percent
Standard Error 0.080
|
8.19 percent
Standard Error 0.080
|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Week 24 Mean
|
7.59 percent
Standard Error 0.098
|
7.39 percent
Standard Error 0.086
|
7.91 percent
Standard Error 0.100
|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Adjusted Mean Change from Baseline
|
-0.66 percent
Standard Error 0.074
|
-0.94 percent
Standard Error 0.075
|
-0.30 percent
Standard Error 0.076
|
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 Plus Open-label TZD
n=193 Participants
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
n=185 Participants
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
n=181 Participants
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline Mean
|
163.0 mg/dL
Standard Error 3.54
|
159.5 mg/dL
Standard Error 3.34
|
162.4 mg/dL
Standard Error 3.43
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Week 24 Mean
|
148.2 mg/dL
Standard Error 3.36
|
143.0 mg/dL
Standard Error 3.20
|
159.3 mg/dL
Standard Error 4.29
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Adjusted Mean Change from Baseline
|
-14.3 mg/dL
Standard Error 2.87
|
-17.3 mg/dL
Standard Error 2.94
|
-2.8 mg/dL
Standard Error 2.97
|
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, subjects 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 Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.
Outcome measures
| Measure |
Saxagliptin 2.5 mg Plus Open-label TZD
n=192 Participants
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
n=184 Participants
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
n=180 Participants
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
Percentage of Participants Achieving A1c <7% at Week 24
|
42.2 Percentage of participants
|
41.8 Percentage of participants
|
25.6 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 2.5 mg Plus Open-label TZD
n=151 Participants
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Saxagliptin 5 mg Plus Open-label TZD
n=131 Participants
The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
Placebo Plus Open-label TZD
n=123 Participants
The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
|
|---|---|---|---|
|
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
|
40255 mg*min/dL
Standard Error 919.7
|
38587 mg*min/dL
Standard Error 991.3
|
44819 mg*min/dL
Standard Error 1023.4
|
|
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
|
-7849 mg*min/dL
Standard Error 740.6
|
-9269 mg*min/dL
Standard Error 794.9
|
-2690 mg*min/dL
Standard Error 820.6
|
|
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
|
48301 mg*min/dL
Standard Error 968.5
|
47866 mg*min/dL
Standard Error 1048.9
|
47256 mg*min/dL
Standard Error 1057.4
|
Adverse Events
PLA + TZD
Serious events: 20 serious events
Other events: 109 other events
Deaths: 0 deaths
SAXA 2.5MG + TZD
Serious events: 19 serious events
Other events: 107 other events
Deaths: 0 deaths
SAXA 5MG + TZD
Serious events: 18 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLA + TZD
n=184 participants at risk
|
SAXA 2.5MG + TZD
n=195 participants at risk
|
SAXA 5MG + TZD
n=186 participants at risk
|
|---|---|---|---|
|
Eye disorders
CATARACT
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Cardiac disorders
TACHYCARDIA
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.6%
3/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.54%
1/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/184
|
1.0%
2/195
|
0.00%
0/186
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Nervous system disorders
CEREBELLAR HAEMORRHAGE
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.54%
1/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Gastrointestinal disorders
VOMITING
|
0.54%
1/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Gastrointestinal disorders
GASTRITIS
|
0.54%
1/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.54%
1/184
|
0.51%
1/195
|
0.54%
1/186
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Infections and infestations
PNEUMONIA
|
0.54%
1/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Infections and infestations
APPENDICITIS
|
0.54%
1/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/184
|
1.0%
2/195
|
0.54%
1/186
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Renal and urinary disorders
RENAL CYST
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.54%
1/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/184
|
0.51%
1/195
|
0.54%
1/186
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
General disorders
PYREXIA
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
General disorders
CHEST PAIN
|
0.54%
1/184
|
0.51%
1/195
|
0.54%
1/186
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON NEOPLASM
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/184
|
0.51%
1/195
|
0.00%
0/186
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.54%
1/184
|
0.00%
0/195
|
0.00%
0/186
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.00%
0/184
|
0.00%
0/195
|
0.54%
1/186
|
Other adverse events
| Measure |
PLA + TZD
n=184 participants at risk
|
SAXA 2.5MG + TZD
n=195 participants at risk
|
SAXA 5MG + TZD
n=186 participants at risk
|
|---|---|---|---|
|
Vascular disorders
HYPERTENSION
|
6.5%
12/184
|
7.7%
15/195
|
5.9%
11/186
|
|
Nervous system disorders
HEADACHE
|
6.5%
12/184
|
7.7%
15/195
|
8.1%
15/186
|
|
Nervous system disorders
DIZZINESS
|
7.6%
14/184
|
5.1%
10/195
|
3.8%
7/186
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.1%
13/184
|
4.1%
8/195
|
5.4%
10/186
|
|
Infections and infestations
BRONCHITIS
|
4.9%
9/184
|
5.6%
11/195
|
3.8%
7/186
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.2%
15/184
|
4.6%
9/195
|
8.1%
15/186
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.2%
17/184
|
11.8%
23/195
|
10.8%
20/186
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.3%
19/184
|
12.8%
25/195
|
12.9%
24/186
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.6%
3/184
|
1.5%
3/195
|
5.9%
11/186
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.8%
7/184
|
6.2%
12/195
|
6.5%
12/186
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.1%
13/184
|
11.3%
22/195
|
5.4%
10/186
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
3.3%
6/184
|
5.1%
10/195
|
6.5%
12/186
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.1%
13/184
|
4.6%
9/195
|
2.7%
5/186
|
|
General disorders
PYREXIA
|
4.3%
8/184
|
3.1%
6/195
|
5.9%
11/186
|
|
General disorders
OEDEMA PERIPHERAL
|
10.3%
19/184
|
4.6%
9/195
|
14.0%
26/186
|
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