Comparison study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus - DURATION-NEO-2

Study identifier:BCB120

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Medical condition

Diabetes Type 2

Phase

Phase 3

Healthy volunteers

Study drug

Exenatide once weekly suspension, Sitagliptin, Placebo

Sex

All

Actual Enrollment

365

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Feb 2013

Primary Completion Date: 01 Apr 2014

Study Completion Date: 01 Apr 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Omaha, NE, United States, 68130

Location

Reseach Site

Rapid City, SD, United States, 57702

Location

Research Site

Hialeah, FL, United States, 33012

Location

Research Site

Miami, FL, United States, 33183

Location

Research Site

Albuquerque, NM, United States, 87102

Location

Research Site

Eugene, OR, United States, 97404

Location

Research Site

Walnut Creek, CA, United States, 94598

Location

Research Site

Burke, VA, United States, 22015

Arms	Assigned Interventions
Experimental: Exenatide once weekly suspension Exenatide once weekly suspension 2mg subcutaneous injection	-
Active Comparator: Sitagliptin 100mg Overencapsulated Sitagliptin 100mg oral tablet once daily	-
Placebo Comparator: Placebo Placebo oral capsule once daily	Drug: Placebo Placebo oral capsule once daily

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
Subjects were randomly assigned across 3 treatment groups (exenatide, sitagliptin, and placebo) in a ratio of 3:2:1, with randomization stratified by screening HbA1c stratum (< 9% or 9%).

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Participant Flow: Overall Study

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
STARTED	182^[1]	122	61
Modified Intent-to-Treat	181^[2]	122	61
Treated	181^[3]	122	61
Evaluable	143^[4]	91	43
Meal Test Subjects	60	41	20
Meal Test Evaluable	44^[5]	31	15
COMPLETED	155^[6]	109	47
NOT COMPLETED	27	13	14
Withdrawal by Subject	14	7	7
Adverse Event	4	0	3
Physician Decision	1	0	1
Protocol Violation	1	0	0
Lost to Follow-up	6	6	3
Administrative	1	0	0

[1]	One subject was enrolled twice at different sites. He was randomized to exenatide at both sites.
[2]	All randomized subjects who received at least one dose of study drug.
[3]	All subjects who received at least one dose of study medication even if not randomized.
[4]	Subjects who completed study procedures to Week 24 or beyond and had adequate study drug exposure
[5]	ITT subjects who ate >=75% of meal and did not miss 2-hour postprandial glucose measures at V3 and 8
[6]	The double-enrolled subject’s reasons for withdrawal were LTFU and PV. Only PV is shown below.

Baseline Characteristics

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

Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Baseline Measures

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo	Total
Number of Participants [units: Participants]	181	122	61	364
Age Continuous [units: Years] Mean ± Standard Deviation	53.4 ± 9.82	54.3 ± 9.01	53.4 ± 9.48	53.7 ± 9.49
Age, Customized [units: Participants]
<65 years	154	106	54	314
>=65 years	27	16	7	50
Gender, Male/Female [units: Participants]
Female	92	56	24	172
Male	89	66	37	192
Race/Ethnicity, Customized [units: Participants]
White	148	98	50	296
Black or African American	24	18	7	49
Asian	9	2	3	14
American Indian or Alaska Native	0	2	1	3
Other	0	1	0	1
Native Hawaiian or Other Pacific Islander	0	1	0	1
Race/Ethnicity, Customized [units: Participants]
Hispanic or Latino	111	77	32	220
Not Hispanic or Latino	70	45	29	144
Weight [units: kg] Mean ± Standard Deviation	89.15 ± 21.413	88.09 ± 20.282	88.95 ± 20.136	88.76 ± 20.778
Baseline HbA1c [units: percentage of total hemoglobin] Mean ± Standard Deviation	8.42 ± 0.997	8.50 ± 1.043	8.50 ± 1.043	8.46 ± 1.018
HbA1c Stratum [units: participants]
< 9.0%	125	83	42	250
>= 9.0%	56	39	19	114
Fasting Plasma Glucose [units: mg/dL] Mean ± Standard Deviation	178.0 ± 46.64	176.9 ± 42.50	172.8 ± 44.31	176.8 ± 44.82

Outcome Measures

1. Primary Outcome Measure: Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Primary
Measure Name	Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28
Measure Description	Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
Time Frame	Baseline to Week 28
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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Measured Values

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Number of Participants Analyzed [units:participants]	181	122	61
Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [units: percentage of total hemoglobin] Least Squares Mean (Standard Error)	-1.13 (0.1093)	-0.75 (0.1324)	-0.40 (0.1945)

Statistical Analysis 1 for Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28

Groups^[1]	Experimental: Exenatide, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.0010
Other^[5]	-0.72
Standard Error of the mean	± 0.2167
95% Confidence Interval	( -1.15 to -0.30 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[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:
	No text entered.

Statistical Analysis 2 for Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28

Groups^[1]	Experimental: Exenatide, Active Comparator: Sitagliptin
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.0209
Other^[5]	-0.38
Standard Error of the mean	± 0.1638
95% Confidence Interval	( -0.70 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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[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:
	No text entered.

Statistical Analysis 3 for Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28

Groups^[1]	Active Comparator: Sitagliptin, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.1347
Other^[5]	-0.34
Standard Error of the mean	± 0.2278
95% Confidence Interval	( -0.79 to 0.11 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[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:
	No text entered.

2. Secondary Outcome Measure: Percentage of Subjects Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Percentage of Subjects Achieving HbA1c <7% at Week 28
Measure Description	Proportions of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.
Time Frame	Baseline to Week 28
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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Measured Values

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Number of Participants Analyzed [units:participants]	181	122	61
Percentage of Subjects Achieving HbA1c <7% at Week 28 [units: percentage of subjects]
Baseline Yes	3.3	1.6	3.3
Baseline No	96.7	98.4	96.7
Week 28 Yes	43.1	32.0	24.6
Week 28 No	56.9	68.0	75.4

Statistical Analysis 1 for Percentage of Subjects Achieving HbA1c <7% at Week 28

Groups^[1]	Experimental: Exenatide, Active Comparator: Sitagliptin
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Cochran-Mantel-Haenszel
P-Value^[4]	0.0489

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Percentage of Subjects Achieving HbA1c <7% at Week 28.
[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.

Statistical Analysis 2 for Percentage of Subjects Achieving HbA1c <7% at Week 28

Groups^[1]	Experimental: Exenatide, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Cochran-Mantel-Haenszel
P-Value^[4]	0.0103

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Percentage of Subjects Achieving HbA1c <7% at Week 28.
[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.

3. Secondary Outcome Measure: Change in fasting plasma glucose concentrations from Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change in fasting plasma glucose concentrations from Baseline to Week 28
Measure Description	The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Time Frame	Baseline to Week 28
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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Measured Values

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Number of Participants Analyzed [units:participants]	181	122	61
Change in fasting plasma glucose concentrations from Baseline to Week 28 [units: mg/dL] Least Squares Mean (Standard Error)	-21.3 (3.864)	-11.3 (4.617)	9.6 (7.097)

Statistical Analysis 1 for Change in fasting plasma glucose concentrations from Baseline to Week 28

Groups^[1]	Experimental: Exenatide, Active Comparator: Sitagliptin
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.0924
Other^[5]	-10.1
Standard Error of the mean	± 5.960
95% Confidence Interval	( -21.8 to 1.7 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[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:
	No text entered.

Statistical Analysis 2 for Change in fasting plasma glucose concentrations from Baseline to Week 28

Groups^[1]	Experimental: Exenatide, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.0001
Other^[5]	-30.9
Standard Error of the mean	± 8.037
95% Confidence Interval	( -46.7 to -15.1 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[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:
	No text entered.

4. Secondary Outcome Measure: Change in body weight (kg) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change in body weight (kg) from baseline to Week 28
Measure Description	The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Time Frame	Baseline to Week 28
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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Measured Values

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Number of Participants Analyzed [units:participants]	181	122	61
Change in body weight (kg) from baseline to Week 28 [units: kg] Least Squares Mean (Standard Error)	-1.12 (0.2592)	-1.19 (0.3134)	0.15 (0.4767)

Statistical Analysis 1 for Change in body weight (kg) from baseline to Week 28

Groups^[1]	Experimental: Exenatide, Active Comparator: Sitagliptin
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.8625
Other^[5]	0.07
Standard Error of the mean	± 0.4058
95% Confidence Interval	( -0.73 to 0.87 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Nominal p-value
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change in body weight (kg) from baseline to Week 28

Groups^[1]	Experimental: Exenatide, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [mixed model for repeated measure]
P-Value^[4]	0.0198
Other^[5]	-1.27
Standard Error of the mean	± 0.5419
95% Confidence Interval	( -2.34 to -0.20 )

[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:
	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Nominal p-value
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8) [ Time Frame: Baseline to Week 16 ]

Measure Type	Secondary
Measure Name	Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8)
Measure Description	The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
Time Frame	Baseline to Week 16
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.
Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Measured Values

	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Number of Participants Analyzed [units:participants]	44	31	15
Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8) [units: mg/dL] Least Squares Mean (Standard Error)	-59.57 (10.48)	-23.61 (13.04)	-38.68 (16.98)

Statistical Analysis 1 for Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8)

Groups^[1]	Experimental: Exenatide, Active Comparator: Sitagliptin
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [general linear model]
P-Value^[4]	0.0248
Other^[5]	-35.96
Standard Error of the mean	± 15.71
95% Confidence Interval	( -67.23 to -4.68 )

[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:
	Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Nominal p-value
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8)

Groups^[1]	Experimental: Exenatide, Placebo Comparator: Placebo
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [general linear model]
P-Value^[4]	0.2914
Other^[5]	-20.89
Standard Error of the mean	± 19.66
95% Confidence Interval	( -60.02 to 18.25 )

[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:
	Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Nominal p-value
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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

Reporting Groups

	Description
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Serious Adverse Events

Experimental: Exenatide

Active Comparator: Sitagliptin

Placebo Comparator: Placebo

Total, serious adverse events

# participants affected / at risk

5/181 (2.76%)

0/122 (0.00%)

2/61 (3.28%)

Gastrointestinal disorders

Abdominal Hernia Obstructive

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

0/61 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

0/61 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Rheumatoid Arthritis

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

0/61 (0.00%)

# events

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

Breast Cancer

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

0/61 (0.00%)

# events

Nervous system disorders

Brain Stem Infarction

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

0/61 (0.00%)

# events

Cardiac disorders

Acute Myocardial Infarction

# participants affected / at risk

0/181 (0.00%)

0/122 (0.00%)

1/61 (1.64%)

# events

Cardiac disorders

Coronary Artery Disease

# participants affected / at risk

0/181 (0.00%)

0/122 (0.00%)

1/61 (1.64%)

# events

Injury, poisoning and procedural complications

Fall

# participants affected / at risk

0/181 (0.00%)

0/122 (0.00%)

1/61 (1.64%)

# events

†	Events were collected by systematic assessment
1	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
Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo	Placebo oral tablet once daily

Other Adverse Events

Experimental: Exenatide

Active Comparator: Sitagliptin

Placebo Comparator: Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

31/181 (17.13%)

2/122 (1.64%)

4/61 (6.56%)

Gastrointestinal disorders

Nausea

# participants affected / at risk

16/181 (8.84%)

2/122 (1.64%)

0/61 (0.00%)

# events

General disorders

Injection Site Nodule

# participants affected / at risk

14/181 (7.73%)

0/122 (0.00%)

0/61 (0.00%)

# events

Infections and infestations

Nasopharyngitis

# participants affected / at risk

1/181 (0.55%)

0/122 (0.00%)

4/61 (6.56%)

# events

†	Events were collected by systematic assessment
1	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:

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:	[email protected]
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

BCB120_Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Peter Ohman

ClinicalTrialTransparency@astrazeneca.com

Investigators

Principal Investigator

Peter Ohman

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Reseach Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

BCB120_Synopsis

Trial Results Summaries