Saxagliptin Triple Oral Therapy

Study identifier:D1680L00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

Study drug

Saxagliptin, Placebo

Sex

All

Actual Enrollment

257

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2010

Primary Completion Date: 01 Jun 2011

Study Completion Date: 01 Jun 2011

Study design

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

Verification:

Verified 01 Aug 2012 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Research Site

BROADMEADOW, NSW, Australia

Location

Research Site

CAMPERDOWN, Australia

Location

Research Site

DAW PARK, SA, Australia

Location

Research Site

ELIZABETH VALE, SA, Australia

Location

Research Site

HERSTON, Australia

Location

Research Site

MELBOURNE, VIC, Australia

Location

Research Site

WOLLONGONG, NSW, Australia

Location

Research Site

KENSINGTON, PE, Canada

Arms	Assigned Interventions
Experimental: Saxagliptin 5 mg once daily	Drug: Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally Other Name: Onglyza
Placebo Comparator: Placebo once daily	Drug: Placebo tablet once daily for 24 weeks to be taken orally

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited to the study from 35 centres in 6 countries (Australia, United Kingdom, Canada, Korea, India and Thailand). Participants were recruited between June 2010 and December 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened over 2 week period. 383 participants enrolled; 126 excluded (11 declined, 114 did not meet eligibility criteria, 1 lost to follow up).

Reporting Groups

	Description
SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Participant Flow: Overall Study

	SAXAGLIPTIN	PLACEBO
STARTED	129^[1]	128^[2]
Full Analysis Set	127^[3]	128^[4]
COMPLETED	113^[5]	113^[6]
NOT COMPLETED	16	15
Adverse Event	1	3
Condition under investigation worsened	8	7
Withdrawal by Subject	2	3
Incorrect enrolment to study	2	1
Protocol Violation	2	0
Developed discontinuation criteria	1	1

[1]	Randomised
[2]	Randomised
[3]	Received at least 1 dose of investigational product during 24 week blinded period
[4]	Received at least 1 dose of investigational product during 24 week blinded period
[5]	Completed 24 weeks
[6]	Completed 24 weeks

Baseline Characteristics

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

Reporting Groups

	Description
SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Baseline Measures

	SAXAGLIPTIN	PLACEBO	Total
Number of Participants [units: Participants]	129	128	257
Age Continuous [units: years] Mean ± Standard Deviation	57.2 ± 9.55	56.8 ± 11.49	57.0 ± 10.54
Gender, Male/Female [units: Participants]
Female	49	54	103
Male	80	74	154
Race, Customized [units: Participants]
White	59	57	116
Asian	70	71	141
Region of Enrollment [units: Participants]
Australia	25	25	50
Canada	10	10	20
India	35	34	69
Korea, Republic of	25	24	49
Thailand	8	10	18
United Kingdom	26	25	51
BMI [units: kg/m2] Mean ± Standard Deviation	29.4 ± 5.26	29.1 ± 4.93	29.2 ± 5.09
HbA1c [units: %] Mean ± Standard Deviation	8.38 ± 0.856	8.19 ± 0.832	8.28 ± 0.848
2-hour Postprandial Glucose [units: mg/dL] Mean ± Standard Deviation	269.18 ± 76.814	265.6 ± 69.713	267.39 ± 73.220
2-hour Postprandial glucose [units: mmol/L] Mean ± Standard Deviation	14.94 ± 4.263	14.74 ± 3.869	14.84 ± 4.064
Fasting Plasma Glucose [units: mg/dL] Mean ± Standard Deviation	162.24 ± 47.322	155.45 ± 38.37	158.84 ± 43.125
Fasting Plasma Glucose [units: mmol/L] Mean ± Standard Deviation	9.00 ± 2.626	8.63 ± 2.130	8.82 ± 2.393

Outcome Measures

1. Primary Outcome Measure: Change in HbA1c from baseline to Week 24, Last Observation Carried Forward (LOCF) [ Time Frame: From Baseline to Week 24 weeks ]

Measure Type	Primary
Measure Name	Change in HbA1c from baseline to Week 24, Last Observation Carried Forward (LOCF)
Measure Description	Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Time Frame	From Baseline to Week 24 weeks
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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	127	127
Change in HbA1c from baseline to Week 24, Last Observation Carried Forward (LOCF) [units: percent] Mean (95% Confidence Interval)	-0.74 (-0.89 to -0.60)	-0.08 (-0.23 to 0.07)

Statistical Analysis 1 for Change in HbA1c from baseline to Week 24, Last Observation Carried Forward (LOCF)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Mean Difference (Final Values)^[5]	-0.66
Standard Error of the mean	± 0.099
95% Confidence Interval	( -0.86 to -0.47 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)

2. Secondary Outcome Measure: Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL] [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Name	Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL]
Measure Description	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time Frame	From Baseline to 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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	115	113
Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL] [units: mg/dL] Mean (95% Confidence Interval)	-11.66 (-23.38 to 0.07)	5.08 (-6.45 to 16.60)

Statistical Analysis 1 for Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL]

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.0301
Mean Difference (Final Values)^[5]	-16.74
Standard Error of the mean	± 7.667
95% Confidence Interval	( -31.85 to -1.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)

3. Secondary Outcome Measure: Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L] [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Name	Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L]
Measure Description	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time Frame	From Baseline to 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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	115	113
Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L] [units: mmol/L] Mean (95% Confidence Interval)	-0.65 (-1.30 to 0.00)	0.28 (-0.36 to 0.92)

Statistical Analysis 1 for Change in 2-hour postprandial glucose (PPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L]

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.0301
Mean Difference (Final Values)^[5]	-0.93
Standard Error of the mean	± 0.426
95% Confidence Interval	( -1.77 to -0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)

4. Secondary Outcome Measure: Change in fasting plasma glucose (FPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL] [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Name	Change in fasting plasma glucose (FPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL]
Measure Description	Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Time Frame	From Baseline to 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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	121	123
Change in fasting plasma glucose (FPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL] [units: mg/dL] Mean (95% Confidence Interval)	-5.28 (-12.67 to 2.11)	2.62 (-4.47 to 9.71)

Statistical Analysis 1 for Change in fasting plasma glucose (FPG) from baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mg/dL]

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.0868
Mean Difference (Final Values)^[5]	-7.90
Standard Error of the mean	± 4.595
95% Confidence Interval	( -16.96 to 1.15 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)

5. Secondary Outcome Measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L] [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Name	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L]
Measure Description	Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Time Frame	From Baseline to 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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	121	123
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L] [units: mmol/L] Mean (95% Confidence Interval)	-0.29 (-0.70 to 0.12)	0.15 (-0.25 to 0.54)

Statistical Analysis 1 for Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) measured as [mmol/L]

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.0868
Mean Difference (Final Values)^[5]	-0.44
Standard Error of the mean	± 0.255
95% Confidence Interval	( -0.94 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)

6. Secondary Outcome Measure: Proportion of participants achieving a therapeutic response: HbA1c less than 7% at Week 24, Last Observation Carried Forward (LOCF) [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Name	Proportion of participants achieving a therapeutic response: HbA1c less than 7% at Week 24, Last Observation Carried Forward (LOCF)
Measure Description	Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
Time Frame	From Baseline to 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.
Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

Reporting Groups

	Description
Arm 1 - SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Arm 2 - PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Measured Values

	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Number of Participants Analyzed [units:participants]	127	127
Proportion of participants achieving a therapeutic response: HbA1c less than 7% at Week 24, Last Observation Carried Forward (LOCF) [units: Participants]	39	12

Statistical Analysis 1 for Proportion of participants achieving a therapeutic response: HbA1c less than 7% at Week 24, Last Observation Carried Forward (LOCF)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Odds Ratio (OR)^[5]	9.006
95% Confidence Interval	( 3.852 to 21.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)

Serious Adverse Events

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

Reporting Groups

	Description
SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Serious Adverse Events

SAXAGLIPTIN

PLACEBO

Total, serious adverse events

# participants affected / at risk

3/129 (2.33%)

7/128 (5.47%)

Infections and infestations

Lower Respiratory Tract Infection¹,^†

# participants affected / at risk

1/129 (0.78%)

0/128 (0.00%)

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Infections and infestations

Osteomyelitis¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal Cancer¹,^†

# participants affected / at risk

1/129 (0.78%)

0/128 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous Cell Carcinoma¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Hepatobiliary disorders

Hepatitis¹,^†

# participants affected / at risk

1/129 (0.78%)

0/128 (0.00%)

Injury, poisoning and procedural complications

Cartilage Injury¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Musculoskeletal and connective tissue disorders

Arthritis¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Stiffness¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Renal and urinary disorders

Renal Colic¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

0/129 (0.00%)

1/128 (0.78%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.0
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	2%

Reporting Groups

	Description
SAXAGLIPTIN	Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
PLACEBO	Placebo tablet once daily for 24 weeks to be taken orally

Other Adverse Events

SAXAGLIPTIN

PLACEBO

Total, other (not including serious) adverse events

# participants affected / at risk

53/129 (41.09%)

65/128 (50.78%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/129 (0.78%)

5/128 (3.91%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/129 (0.78%)

3/128 (2.34%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

7/129 (5.43%)

5/128 (3.91%)

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

4/129 (3.10%)

0/128 (0.00%)

Gastrointestinal disorders

Gastritis¹,^†

# participants affected / at risk

3/129 (2.33%)

3/128 (2.34%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

2/129 (1.55%)

4/128 (3.13%)

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

8/129 (6.20%)

12/128 (9.38%)

Infections and infestations

Oral Candidiasis¹,^†

# participants affected / at risk

0/129 (0.00%)

3/128 (2.34%)

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

0/129 (0.00%)

3/128 (2.34%)

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

6/129 (4.65%)

6/128 (4.69%)

Infections and infestations

Urinary Tract Infection¹,^†

# participants affected / at risk

4/129 (3.10%)

8/128 (6.25%)

Metabolism and nutrition disorders

Dyslipidaemia¹,^†

# participants affected / at risk

5/129 (3.88%)

7/128 (5.47%)

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

4/129 (3.10%)

4/128 (3.13%)

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

2/129 (1.55%)

3/128 (2.34%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

1/129 (0.78%)

4/128 (3.13%)

Musculoskeletal and connective tissue disorders

Pain In Extremity¹,^†

# participants affected / at risk

2/129 (1.55%)

4/128 (3.13%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

3/129 (2.33%)

2/128 (1.56%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

4/129 (3.10%)

3/128 (2.34%)

Nervous system disorders

Neuropathy Peripheral¹,^†

# participants affected / at risk

3/129 (2.33%)

0/128 (0.00%)

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

0/129 (0.00%)

3/128 (2.34%)

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

4/129 (3.10%)

1/128 (0.78%)

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

2/129 (1.55%)

3/128 (2.34%)

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

7/129 (5.43%)

2/128 (1.56%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.0
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: At least 60 days prior to submission of any material for publication or presentation, PI shall provide Sponsor with such material for review. If requested in writing by Sponsor, PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of Sponsor's request.

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:	Gerard Lynch
Organization:	AstraZeneca
Phone	+44 1625 518062
E-mail:	[email protected]

Documents available

CSR-D1680L00006.pdf
Download
Clinical Study Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Australia Medical Information

medinfo.australia@astrazeneca.com

Investigators

Principal Investigator

Jayanti Visvanthan

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR-D1680L00006.pdf

Clinical Study Protocol

Trial Results Summaries