A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

Study identifier:CV181-013

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Healthy volunteers

Study drug

Saxagliptin, Placebo, pioglitazone, rosiglitazone, metformin

Sex

All

Actual Enrollment

565

Study type

Interventional

Age

18 Years - 77 Years

Date

Study Start Date: 01 Mar 2006

Primary Completion Date: 01 Oct 2007

Study Completion Date: 01 Oct 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Professional Research Network Of Kansas

Wichita, KS, United States, 67203

Location

Urgentmed, P.C.

South Bound Brook, NJ, United States, 08880

Location

Mission Internal Medical Group

Mission Viejo, CA, United States, 92691

Location

Medical Group Of Encino

Encino, CA, United States, 91436

Location

Jacksonville Center For Clinical Research

Jacksonville, FL, United States, 32205

Location

Winston Technology, Inc.

Haleyville, AL, United States, 35565

Location

Med-Cure

Rosenberg, TX, United States, 77471

Location

Medical Research Associates Of Charlotte, Inc.

Charlotte, NC, United States, 28211

Arms	Assigned Interventions
Experimental: Saxagliptin plus open-label TZD (A) Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Experimental: Saxagliptin plus open-label TZD (B) Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Saxagliptin Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Placebo Comparator: Placebo plus open-label TZD (C) Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Placebo Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Saxagliptin 2.5 mg plus open-label Thiazolidinedione (TZD)	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD
STARTED	195	186	184
Completed study without being rescued	88	82	51
COMPLETED	133	119	108
NOT COMPLETED	62	67	76
Lack of Efficacy	19	7	16
Withdrawal of consent by subject	16	16	26
Adverse Event	9	17	9
Lost to Follow-up	6	11	7
Physician Decision	9	10	8
Poor/Noncompliance	2	2	6
Subject No Longer Meets Study Criteria	0	3	3
Death	1	1	0
Administrative reason by sponsor	0	0	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Saxagliptin 2.5 mg plus open-label 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.

Baseline Measures

	Saxagliptin 2.5 mg plus open-label TZD	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD	Total
Number of Participants [units: Participants]	195	186	184	565
Age Continuous [units: years] Mean ± Standard Deviation	54.85 ± 9.73	53.22 ± 10.56	54.01 ± 10.08	54.04 ± 10.13
Gender, Male/Female [units: participants]
Female	89	97	99	285
Male	106	89	85	280

Outcome Measures

1. Primary Outcome Measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]

Measure Type	Primary
Measure Name	Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Measure Description	Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time Frame	Baseline, Week 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Saxagliptin 2.5 mg plus open-label 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.

Measured Values

	Saxagliptin 2.5 mg plus open-label TZD	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD
Number of Participants Analyzed [units:participants]	192	183	180
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [units: percent] Mean (Standard Error)
Baseline Mean	8.25 (0.080)	8.35 (0.080)	8.19 (0.080)
Week 24 Mean	7.59 (0.098)	7.39 (0.086)	7.91 (0.100)
Adjusted Mean Change from Baseline	-0.66 (0.074)	-0.94 (0.075)	-0.30 (0.076)

No statistical analysis provided for Change From Baseline in Hemoglobin A1c (A1C) at Week 24

2. Secondary Outcome Measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Measure Description	Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time Frame	Baseline, Week 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Saxagliptin 2.5 mg plus open-label 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.

Measured Values

	Saxagliptin 2.5 mg plus open-label TZD	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD
Number of Participants Analyzed [units:participants]	193	185	181
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [units: mg/dL] Mean (Standard Error)
Baseline Mean	163.0 (3.54)	159.5 (3.34)	162.4 (3.43)
Week 24 Mean	148.2 (3.36)	143.0 (3.20)	159.3 (4.29)
Adjusted Mean Change from Baseline	-14.3 (2.87)	-17.3 (2.94)	-2.8 (2.97)

No statistical analysis provided for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

3. Secondary Outcome Measure: Percentage of Participants Achieving A1c <7% at Week 24 [ Time Frame: Week 24 ]

Measure Type	Secondary
Measure Name	Percentage of Participants Achieving A1c <7% at Week 24
Measure Description	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.
Time Frame	Week 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Saxagliptin 2.5 mg plus open-label 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.

Measured Values

	Saxagliptin 2.5 mg plus open-label TZD	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD
Number of Participants Analyzed [units:participants]	192	184	180
Percentage of Participants Achieving A1c <7% at Week 24 [units: Percentage of participants]	42.2	41.8	25.6

No statistical analysis provided for Percentage of Participants Achieving A1c <7% at Week 24

4. Secondary Outcome Measure: Changes from baseline in postprandial glucose (PPG) area under the curve (AUC) response to an oral glucose tolerance test (OGTT) at week 24 [ Time Frame: Baseline, Week 24 ]

Measure Type	Secondary
Measure Name	Changes from baseline in postprandial glucose (PPG) area under the curve (AUC) response to an oral glucose tolerance test (OGTT) at week 24
Measure Description	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.
Time Frame	Baseline, Week 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Saxagliptin 2.5 mg plus open-label 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.

Measured Values

	Saxagliptin 2.5 mg plus open-label TZD	Saxagliptin 5 mg plus open-label TZD	Placebo plus open-label TZD
Number of Participants Analyzed [units:participants]	151	131	123
Changes from baseline in postprandial glucose (PPG) area under the curve (AUC) response to an oral glucose tolerance test (OGTT) at week 24 [units: mg*min/dL] Mean (Standard Error)
Baseline Mean	48301 (968.5)	47866 (1048.9)	47256 (1057.4)
Week 24 Mean	40255 (919.7)	38587 (991.3)	44819 (1023.4)
Adjusted Mean Change from Baseline	-7849 (740.6)	-9269 (794.9)	-2690 (820.6)

No statistical analysis provided for Changes from baseline in postprandial glucose (PPG) area under the curve (AUC) response to an oral glucose tolerance test (OGTT) at week 24

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
PLA + TZD	No text entered.
SAXA 2.5MG + TZD	No text entered.
SAXA 5MG + TZD	No text entered.

Serious Adverse Events

PLA + TZD

SAXA 2.5MG + TZD

SAXA 5MG + TZD

Total, serious adverse events

# participants affected / at risk

20/184 (10.87%)

19/195 (9.74%)

18/186 (9.68%)

EYE DISORDERS

CATARACT¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

INVESTIGATIONS

BLOOD PRESSURE INCREASED¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

CARDIAC DISORDERS

TACHYCARDIA¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

CARDIAC DISORDERS

ANGINA PECTORIS¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

CARDIAC DISORDERS

ATRIAL FIBRILLATION¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

CARDIAC DISORDERS

CORONARY ARTERY DISEASE¹,^†

# participants affected / at risk

3/184 (1.63%)

1/195 (0.51%)

0/186 (0.00%)

CARDIAC DISORDERS

CARDIAC FAILURE CONGESTIVE¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

CARDIAC DISORDERS

ACUTE MYOCARDIAL INFARCTION¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

0/186 (0.00%)

VASCULAR DISORDERS

HYPERTENSION¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

PSYCHIATRIC DISORDERS

ANXIETY¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

PSYCHIATRIC DISORDERS

ALCOHOL ABUSE¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

HEPATOBILIARY DISORDERS

CHOLECYSTITIS¹,^†

# participants affected / at risk

0/184 (0.00%)

2/195 (1.03%)

0/186 (0.00%)

NERVOUS SYSTEM DISORDERS

CEREBRAL HAEMATOMA¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

NERVOUS SYSTEM DISORDERS

CEREBRAL INFARCTION¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

NERVOUS SYSTEM DISORDERS

CEREBELLAR HAEMORRHAGE¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

NERVOUS SYSTEM DISORDERS

CAROTID ARTERY STENOSIS¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

NERVOUS SYSTEM DISORDERS

CEREBROVASCULAR ACCIDENT¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

NERVOUS SYSTEM DISORDERS

TRANSIENT ISCHAEMIC ATTACK¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

0/186 (0.00%)

GASTROINTESTINAL DISORDERS

VOMITING¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

1/186 (0.54%)

GASTROINTESTINAL DISORDERS

DIARRHOEA¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

GASTROINTESTINAL DISORDERS

GASTRITIS¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

0/186 (0.00%)

GASTROINTESTINAL DISORDERS

ANAL FISTULA¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

GASTROINTESTINAL DISORDERS

ABDOMINAL PAIN¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

1/186 (0.54%)

GASTROINTESTINAL DISORDERS

PANCREATITIS ACUTE¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

GASTROINTESTINAL DISORDERS

IRRITABLE BOWEL SYNDROME¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

GASTROINTESTINAL DISORDERS

SMALL INTESTINAL OBSTRUCTION¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

INFECTIONS AND INFESTATIONS

ORCHITIS¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

INFECTIONS AND INFESTATIONS

PNEUMONIA¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

1/186 (0.54%)

INFECTIONS AND INFESTATIONS

ANAL ABSCESS¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

INFECTIONS AND INFESTATIONS

APPENDICITIS¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

0/186 (0.00%)

INFECTIONS AND INFESTATIONS

GASTROENTERITIS¹,^†

# participants affected / at risk

0/184 (0.00%)

2/195 (1.03%)

1/186 (0.54%)

INFECTIONS AND INFESTATIONS

MENINGITIS ASEPTIC¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

INFECTIONS AND INFESTATIONS

STAPHYLOCOCCAL INFECTION¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

RENAL AND URINARY DISORDERS

RENAL CYST¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

RENAL AND URINARY DISORDERS

NEPHROLITHIASIS¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

1/186 (0.54%)

RENAL AND URINARY DISORDERS

CALCULUS BLADDER¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

RENAL AND URINARY DISORDERS

CALCULUS URETERIC¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

METABOLISM AND NUTRITION DISORDERS

DEHYDRATION¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

METABOLISM AND NUTRITION DISORDERS

HYPOVOLAEMIA¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

RASH¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

SKIN ULCER¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

REPRODUCTIVE SYSTEM AND BREAST DISORDERS

ENDOMETRIOSIS¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

REPRODUCTIVE SYSTEM AND BREAST DISORDERS

PROSTATOMEGALY¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

REPRODUCTIVE SYSTEM AND BREAST DISORDERS

POSTMENOPAUSAL HAEMORRHAGE¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

OVERDOSE¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

BACK INJURY¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

LIMB INJURY¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

FIBULA FRACTURE¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

ROAD TRAFFIC ACCIDENT¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

BACK PAIN¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

OSTEOARTHRITIS¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

INTERVERTEBRAL DISC PROTRUSION¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

1/186 (0.54%)

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

ASTHMA¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

CHRONIC OBSTRUCTIVE PULMONARY DISEASE¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PYREXIA¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

CHEST PAIN¹,^†

# participants affected / at risk

1/184 (0.54%)

1/195 (0.51%)

1/186 (0.54%)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

SUDDEN DEATH¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

COLON NEOPLASM¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

MALIGNANT MELANOMA¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

BASAL CELL CARCINOMA¹,^†

# participants affected / at risk

0/184 (0.00%)

1/195 (0.51%)

0/186 (0.00%)

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

SQUAMOUS CELL CARCINOMA¹,^†

# participants affected / at risk

1/184 (0.54%)

0/195 (0.00%)

0/186 (0.00%)

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

METASTATIC SQUAMOUS CELL CARCINOMA¹,^†

# participants affected / at risk

0/184 (0.00%)

0/195 (0.00%)

1/186 (0.54%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
PLA + TZD	No text entered.
SAXA 2.5MG + TZD	No text entered.
SAXA 5MG + TZD	No text entered.

Other Adverse Events

PLA + TZD

SAXA 2.5MG + TZD

SAXA 5MG + TZD

Total, other (not including serious) adverse events

# participants affected / at risk

109/184 (59.24%)

107/195 (54.87%)

109/186 (58.60%)

VASCULAR DISORDERS

HYPERTENSION¹,^†

# participants affected / at risk

12/184 (6.52%)

15/195 (7.69%)

11/186 (5.91%)

NERVOUS SYSTEM DISORDERS

HEADACHE¹,^†

# participants affected / at risk

12/184 (6.52%)

15/195 (7.69%)

15/186 (8.06%)

NERVOUS SYSTEM DISORDERS

DIZZINESS¹,^†

# participants affected / at risk

14/184 (7.61%)

10/195 (5.13%)

7/186 (3.76%)

GASTROINTESTINAL DISORDERS

DIARRHOEA¹,^†

# participants affected / at risk

13/184 (7.07%)

8/195 (4.10%)

10/186 (5.38%)

INFECTIONS AND INFESTATIONS

BRONCHITIS¹,^†

# participants affected / at risk

9/184 (4.89%)

11/195 (5.64%)

7/186 (3.76%)

INFECTIONS AND INFESTATIONS

NASOPHARYNGITIS¹,^†

# participants affected / at risk

15/184 (8.15%)

9/195 (4.62%)

15/186 (8.06%)

INFECTIONS AND INFESTATIONS

URINARY TRACT INFECTION¹,^†

# participants affected / at risk

17/184 (9.24%)

23/195 (11.79%)

20/186 (10.75%)

INFECTIONS AND INFESTATIONS

UPPER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

19/184 (10.33%)

25/195 (12.82%)

24/186 (12.90%)

BLOOD AND LYMPHATIC SYSTEM DISORDERS

ANAEMIA¹,^†

# participants affected / at risk

3/184 (1.63%)

3/195 (1.54%)

11/186 (5.91%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

BACK PAIN¹,^†

# participants affected / at risk

7/184 (3.80%)

12/195 (6.15%)

12/186 (6.45%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

ARTHRALGIA¹,^†

# participants affected / at risk

13/184 (7.07%)

22/195 (11.28%)

10/186 (5.38%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

MUSCULOSKELETAL PAIN¹,^†

# participants affected / at risk

6/184 (3.26%)

10/195 (5.13%)

12/186 (6.45%)

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

COUGH¹,^†

# participants affected / at risk

13/184 (7.07%)

9/195 (4.62%)

5/186 (2.69%)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PYREXIA¹,^†

# participants affected / at risk

8/184 (4.35%)

6/195 (3.08%)

11/186 (5.91%)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

OEDEMA PERIPHERAL¹,^†

# participants affected / at risk

19/184 (10.33%)

9/195 (4.62%)

26/186 (13.98%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Boaz Hirschberg
Organization:	AstraZeneca Pharmaceuticals
E-mail:	[email protected]

Documents available

BMS Clinical Trials Disclosure
Download
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Download
PhRMA website - CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical null

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Professional Research Network Of Kansas

Urgentmed, P.C.

Mission Internal Medical Group

Medical Group Of Encino

Jacksonville Center For Clinical Research

Winston Technology, Inc.

Med-Cure

Medical Research Associates Of Charlotte, Inc.

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

PhRMA website - CSR Synopsis

Trial Results Summaries