Comparison Study of the Glycemic Effects, Safety, and Tol... | NCT01652729

ID	Type	Description	Link
MB001-004	Other Identifier	Bristol Myers Squibb

Comparison Study of the Glycemic Effects, Safety, and Tol... | NCT01652729 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exenatide once weekly suspension	Experimental	Exenatide once weekly suspension 2mg subcutaneous injection	Drug: Exenatide once weekly suspension
Sitagliptin 100mg	Active Comparator	Overencapsulated Sitagliptin 100mg oral tablet once daily	Drug: Sitagliptin
Placebo	Placebo Comparator	Placebo oral capsule once daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Exenatide once weekly suspension	Drug		Exenatide once weekly suspension
Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28	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.	Baseline to Week 28

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Achieving HbA1c <7% at Week 28	Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.	Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

Contacts/Locations Module

Name	Affiliation	Role
Peter Ohman	AstraZeneca	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35216	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32306296	Derived	Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
28205322	Derived	Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.

Label	URL
BCB120\_Synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
FG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Withdrawal by Subject		FG00014 subjects FG0017 subjects FG0027 subjects
Adverse Event		FG0004 subjects FG0010 subjects FG0023 subjects
Physician Decision		FG0001 subjects FG0010 subjects FG0021 subjects
Protocol Violation		FG0001 subjects FG0010 subjects FG0020 subjects
Lost to Follow-up		FG0006 subjects FG0016 subjects FG0023 subjects
Administrative		FG0001 subjects FG0010 subjects FG0020 subjects

Arm/Group Information

ID	Title	Description
BG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
BG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
BG002	Placebo Comparator: Placebo	Placebo oral tablet once daily
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00053.4± 9.82 BG00154.3± 9.01 BG00253.4± 9.48 BG003

Age, Customized

Number

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG000154 BG001106 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00092 BG00156 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000148 BG00198 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG000111 BG00177 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00089.15± 21.413 BG00188.09± 20.282 BG002

Baseline HbA1c

Mean

Standard Deviation

percentage of total hemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.42± 0.997 BG0018.50± 1.043 BG002

HbA1c Stratum

Number

participants

Title

Denominators

Categories

< 9.0%

Title	Measurements
	BG000125 BG00183 BG002

Fasting Plasma Glucose

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000178.0± 46.64 BG001176.9± 42.50 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28

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.

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

Posted

Least Squares Mean

Standard Error

percentage of total hemoglobin

Baseline to Week 28

ID	Title	Description
OG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
OG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
OG002	Placebo Comparator: Placebo	Placebo oral tablet once daily

Units	Counts
Participants	OG000181 OG001122 OG00261

Title

Denominators

Categories

Title	Measurements
	OG000-1.13± 0.1093 OG001-0.75± 0.1324 OG002-0.40± 0.1945

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		mixed model for repeated measure	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.	0.0010		LS Mean Difference	-0.72	Standard Error of the Mean	0.2167	2-Sided	95	-1.15	-0.30				No	Superiority or Other
OG000 OG001

Secondary

Percentage of Subjects Achieving HbA1c <7% at Week 28

Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.

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

Posted

Number

percentage of subjects

Baseline to Week 28

ID	Title	Description
OG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
OG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
OG002	Placebo Comparator: Placebo	Placebo oral tablet once daily

Units	Counts
Participants	OG000

Secondary

Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline to Week 28

ID	Title	Description
OG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
OG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
OG002	Placebo Comparator: Placebo	Placebo oral tablet once daily

Units	Counts
Participants	OG000

Secondary

Change in Body Weight (kg) From Baseline to Week 28

The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.

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

Posted

Least Squares Mean

Standard Error

Baseline to Week 28

ID	Title	Description
OG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
OG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
OG002	Placebo Comparator: Placebo	Placebo oral tablet once daily

Units	Counts
Participants	OG000

Secondary

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)

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.

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.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline to Week 16

ID	Title	Description
OG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection
OG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily
OG002	Placebo Comparator: Placebo	Placebo oral tablet once daily

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental: Exenatide	Exenatide once weekly suspension 2mg subcutaneous injection	5	181	31	181
EG001	Active Comparator: Sitagliptin	Sitagliptin 100mg oral tablet once daily	0	122	2	122
EG002	Placebo Comparator: Placebo	Placebo oral tablet once daily	2	61	4	61

Serious Adverse Events

Term	Organ System	Statistical Information
Abdominal Hernia Obstructive	Gastrointestinal disorders	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Diarrhoea	Gastrointestinal disorders	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Brain Stem Infarction	Nervous system disorders	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Acute Myocardial Infarction	Cardiac disorders	EG0000 events0 affected181 at risk EG0010 events0 affected122 at risk EG0021 events1 affected61 at risk
Coronary Artery Disease	Cardiac disorders	EG0000 events0 affected181 at risk EG0010 events0 affected122 at risk EG0021 events1 affected61 at risk
Fall	Injury, poisoning and procedural complications	EG0000 events0 affected181 at risk EG0010 events0 affected122 at risk EG0021 events1 affected61 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Nausea	Gastrointestinal disorders	EG00018 events16 affected181 at risk EG0012 events2 affected122 at risk EG0020 events0 affected61 at risk
Injection Site Nodule	General disorders	EG00019 events14 affected181 at risk EG0010 events0 affected122 at risk EG0020 events0 affected61 at risk
Nasopharyngitis	Infections and infestations	EG0001 events1 affected181 at risk EG0010 events0 affected122 at risk EG0024 events4 affected61 at risk

Title

Denominators

Categories

Baseline Yes

Title	Measurements
	OG0003.3 OG0011.6 OG0023.3

Baseline No

Title	Measurements
	OG00096.7 OG00198.4 OG00296.7

Week 28 Yes

Title	Measurements
	OG00043.1 OG00132.0 OG00224.6

Week 28 No

Title	Measurements
	OG00056.9 OG00168.0 OG00275.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Percentage of Subjects Achieving HbA1c <7% at Week 28.	Cochran-Mantel-Haenszel		0.0489													No	Superiority or Other
OG000 OG002	Percentage of Subjects Achieving HbA1c <7% at Week 28.	Cochran-Mantel-Haenszel		0.0103													No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		mixed model for repeated measure	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.	0.0924		LS Mean Difference	-10.1	Standard Error of the Mean	5.960	2-Sided	95	-21.8	1.7				No	Superiority or Other
OG000 OG002		mixed model for repeated measure	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.	0.0001		LS Mean Difference	-30.9	Standard Error of the Mean	8.037	2-Sided	95	-46.7	-15.1				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		mixed model for repeated measure	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.	0.8625	Nominal p-value	LS Mean Difference	0.07	Standard Error of the Mean	0.4058	2-Sided	95	-0.73	0.87				No	Superiority or Other
OG000 OG002		mixed model for repeated measure	MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.	0.0198	Nominal p-value	LS Mean Difference	-1.27	Standard Error of the Mean	0.5419	2-Sided	95	-2.34	-0.20				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		general linear model	Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.	0.0248	Nominal p-value	LS Mean Difference	-35.96	Standard Error of the Mean	15.71	2-Sided	95	-67.23	-4.68				No	Superiority or Other
OG000 OG002		general linear model	Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.	0.2914	Nominal p-value	LS Mean Difference	-20.89	Standard Error of the Mean	19.66	2-Sided	95	-60.02	18.25				No	Superiority or Other

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines