Efficacy and Safety of Exenatide Once Weekly Suspension i... | NCT01652716

NCT01652716

ID	Type	Description	Link
MB001-003	Other Identifier	Bristol Myers Squibb

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exenatide once weekly suspension	Experimental	Exenatide suspension 2 mg weekly subcutaneous injection	Drug: Exenatide once weekly suspension
Exenatide twice daily (BID)	Active Comparator	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks	Drug: Exenatide twice daily

Name	Type	Description	Arm Group Labels	Other Names
Exenatide once weekly suspension	Drug	Exenatide suspension 2 mg weekly subcutaneous injection	Exenatide once weekly suspension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28	The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.	Baseline to Week 28

Secondary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Vice President Medical Research & Development, M.D.	Amylin Pharmaceuticals, LLC.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Muscle Shoals	Alabama	35662	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33037036	Derived	Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
28685973

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental: Exenatide Once Weekly (QWS) Suspension	Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
FG001	Active Comparator: Exenatide Twice Daily (BID)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination

Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

FG001148 subjectsTwo subjects in the exenatide BID group withdrew from the study before receiving study drug.

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

Arm/Group Information

ID	Title	Description
BG000	Experimental: Exenatide QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
BG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
BG002	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
	BG00055.6± 9.98 BG00156.5± 9.04 BG00256.0± 9.62

Age, Customized

Number

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG000182 BG001118 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00081 BG00154 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00054 BG00134 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000168 BG001110 BG002

Weight

Mean

Standard Deviation

lbs

Title

Denominators

Categories

Title	Measurements
	BG000214.52± 49.788 BG001213.19± 40.834 BG002

Baseline HbA1c

Mean

Standard Deviation

Percentage of total hemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.47± 1.047 BG0018.51± 1.004 BG002

HbA1c Stratum

Number

Number of subjects

Title

Denominators

Categories

<9.0%

Title	Measurements
	BG000159 BG00197 BG002

Fasting plasma glucose

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000180.92± 44.538 BG001183.77± 46.904 BG002

Duration of diabetes

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0008.55± 6.249 BG0018.47± 5.961 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

The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

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 QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
OG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

Units	Counts
Participants	OG000229 OG001146

Title

Denominators

Categories

Title	Measurements
	OG000-1.39± 0.0930 OG001-1.02± 0.1147

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)	Based on a repeated measures mixed model including fixed categorical effects of treatment	0.0072		LS Mean Difference	-0.37	Standard Error of the Mean	0.1349	2-Sided	95	-0.63	-0.10					Superiority or Other

Secondary

Percentage of Subjects Achieving HbA1c <7% at Week 28

Percentage of subjects achieving HbA1c <7% 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 QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
OG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

Units	Counts
Participants	OG000

Secondary

Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

Change in fasting plasma glucose concentrations from baseline 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 QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
OG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

Units	Counts
Participants	OG000

Secondary

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

Change in body weight (kg) from baseline 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 QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
OG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

Units	Counts
Participants	OG000

Secondary

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16

Change in 2-hour postprandial glucose concentrations from baseline to Week 16.

Meal Test Evaluable Subjects: Subjects who were randomized and received at least one dose of study drug and who participated in the meal test at Visit 3 and Visit 13, had adequate and reliable data for the postprandial data evaluation, and had adequate study medication exposure.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline to Week 16

ID	Title	Description
OG000	Experimental: Exenatide QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
OG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental: Exenatide QWS Suspension	Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)			12	229	121	229
EG001	Active Comparator: Exenatide BID	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks			17	146	94	146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Localised Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Salmonellosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Septic Shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Myocardial Infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected229 at risk EG0010 events0 affected146 at risk
Diverticular Perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Toxic Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Hidradentis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Lactic Acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Infectious Colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected229 at risk EG0010 events0 affected146 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Chest Pain	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected229 at risk EG0011 events1 affected146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection Site Nodule	General disorders	MedDRA	Systematic Assessment	EG00037 events36 affected229 at risk EG0016 events6 affected146 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00030 events22 affected229 at risk EG00138 events33 affected146 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00016 events14 affected229 at risk EG00110 events9 affected146 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00016 events15 affected229 at risk EG0019 events8 affected146 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00023 events14 affected229 at risk EG00124 events18 affected146 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 events9 affected229 at risk EG00111 events11 affected146 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events11 affected229 at risk EG00111 events9 affected146 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D000077270	Exenatide

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors