Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

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ClinicalTrials.gov Identifier: NCT00985114

Recruitment Status : Completed

First Posted : September 28, 2009

Results First Posted : October 3, 2016

Last Update Posted : October 3, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

GI Dynamics

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Type II Diabetes
Interventions	Device: EndoBarrier Behavioral: Diet + Lifestyle Counseling
Enrollment	77

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	EndoBarrier Device	Diet + Lifestyle Counseling
Arm/Group Description	EndoBarrier ...	Multidisciplinary lifestyle and nut...
Arm/Group Description	EndoBarrier EndoBarrier: EndoBarrier implant	Multidisciplinary lifestyle and nutritional counseling Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
Period Title: Overall Study
Started	34 ^[1]	39
Diet + Lifestyle Counseling Cross-over	0	28 ^[2]
Completed	33	37
Not Completed	1	2
Reason Not Completed
Adverse Event	1	0
Withdrawal by Subject	0	2
[1] 38 randomized, 34 received the device [2] Received device for intended period of 12 months with 6 months follow up

Baseline Characteristics

Arm/Group Title		Device	Diet + Lifestyle Counseling	Total
Arm/Group Description		EndoBarrier ...	Multidisciplinary lifestyle and nut...	Total of all reporting groups
Arm/Group Description		EndoBarrier EndoBarrier: EndoBarrier implant	Multidisciplinary lifestyle and nutritional counseling Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling	Total of all reporting groups
Overall Number of Baseline Participants		34	39	73
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	34 participants	39 participants	73 participants
		49.8 (9.1)	49.3 (7.8)	49.3 (8.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	34 participants	39 participants	73 participants
	Female	13 38.2%	14 35.9%	27 37.0%
	Male	21 61.8%	25 64.1%	46 63.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Netherlands	Number Analyzed	34 participants	39 participants	73 participants
Netherlands		34	39	73
Baseline weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	34 participants	39 participants	73 participants
		110.1 (19.5)	113.5 (19.3)	111.9 (19.3)

Outcome Measures

1.Primary Outcome


Title	Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Device	Diet + Lifestyle Counseling
Arm/Group Description:	EndoBarrier ...	Multidisciplinary lifestyle and nut...
Arm/Group Description:	EndoBarrier EndoBarrier: EndoBarrier implant	Multidisciplinary lifestyle and nutritional counseling Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
Overall Number of Participants Analyzed	33	36
Measure Type: Number Unit of Measure: % of participants
	81.8	61.1

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Device and Cross Over		Diet + Lifestyle Counseling
Arm/Group Description	EndoBarrier ...		Multidisciplinary lifestyle and nut...
Arm/Group Description	EndoBarrier EndoBarrier: EndoBarrier implant		Multidisciplinary lifestyle and nutritional counseling Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
All-Cause Mortality
	Device and Cross Over		Diet + Lifestyle Counseling
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Device and Cross Over		Diet + Lifestyle Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/66 (27.27%)		4/39 (10.26%)
Cardiac disorders
Pericarditis ^* 1	1/66 (1.52%)	1	1/39 (2.56%)	1
Myocardial infarction ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Gastrointestinal disorders
Abdominal pain upper ^* 1	5/66 (7.58%)	5	0/39 (0.00%)	0
Abdominal pain lower ^* 1	4/66 (6.06%)	4	0/39 (0.00%)	0
Abdominal pain ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Diverticulitis ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Melena ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Abdominal discomfort ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Vomiting ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Constipation ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Pylorospasm ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Hepatobiliary disorders
Cholelithiasis ^* 1	1/66 (1.52%)	1	1/39 (2.56%)	1
Injury, poisoning and procedural complications
Accidental Overdose ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Procedural Nausea ^* 1	2/66 (3.03%)	2	0/39 (0.00%)	0
Procedural Vomiting ^* 1	2/66 (3.03%)	2	0/39 (0.00%)	0
Metabolism and nutrition disorders
Hypoglycemia ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Dehydration ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Scapula fracture ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Acute hernia ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Arthralgia ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Back pain ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney carcinoma ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Metastases to spine ^* 1	1/66 (1.52%)	1	0/39 (0.00%)	0
Psychiatric disorders
Mental disorder ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
Renal and urinary disorders
Urinary incontinence ^* 1	0/66 (0.00%)	0	1/39 (2.56%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MeDdRA 10.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Device and Cross Over		Diet + Lifestyle Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/66 (83.33%)		25/39 (64.10%)
Gastrointestinal disorders
Abdominal pain upper ^* 1	31/66 (46.97%)	47	4/39 (10.26%)	4
Abdominal discomfort ^* 1	4/66 (6.06%)	4	0/39 (0.00%)	0
Abdominal pain ^* 1	11/66 (16.67%)	15	0/39 (0.00%)	0
Abdominal pain lower ^* 1	13/66 (19.70%)	20	1/39 (2.56%)	1
Constipation ^* 1	14/66 (21.21%)	15	4/39 (10.26%)	4
Diarrhea ^* 1	4/66 (6.06%)	4	3/39 (7.69%)	3
Nausea ^* 1	14/66 (21.21%)	21	6/39 (15.38%)	6
Vomiting ^* 1	8/66 (12.12%)	11	4/39 (10.26%)	4
Procedural vomiting ^* 1	8/66 (12.12%)	8	1/39 (2.56%)	1
Immune system disorders
Hypersensitivity ^* 2	0/66 (0.00%)	0	2/39 (5.13%)	2
Infections and infestations
Nasopharyngitis ^* 2	3/66 (4.55%)	3	3/39 (7.69%)	3
Pneumonia ^* 2	1/66 (1.52%)	2	2/39 (5.13%)	2
Injury, poisoning and procedural complications
Procedural nausea ^* 1	17/66 (25.76%)	18	0/39 (0.00%)	0
Metabolism and nutrition disorders
Hypoglycemia ^* 1	14/66 (21.21%)	48	11/39 (28.21%)	11
Hypovitaminosis ^* 1	4/66 (6.06%)	4	0/39 (0.00%)	0
Iron deficiency ^* 2	18/66 (27.27%)	22	10/39 (25.64%)	10
Hyperglycemia ^* 2	0/66 (0.00%)	0	2/39 (5.13%)	2
Musculoskeletal and connective tissue disorders
Arthralgia ^* 2	4/66 (6.06%)	5	3/39 (7.69%)	3
Back pain ^* 2	4/66 (6.06%)	6	1/39 (2.56%)	1
Pain in extremity ^* 2	0/66 (0.00%)	0	3/39 (7.69%)	3
Nervous system disorders
Headache ^* 2	4/66 (6.06%)	4	1/39 (2.56%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA (10.0) 2 Term from vocabulary, medDRA 10.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Clinical Affairs Manager
Organization:	GI Dynamics, Inc.
Phone:	781.357.3263
EMail:	kwoessner@gidynamics.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Bouvy ND, Greve JW. Impact of Duodenal-Jejunal Exclusion on Satiety Hormones. Obes Surg. 2016 Mar;26(3):672-8. doi: 10.1007/s11695-015-1889-y.

Koehestanie P, de Jonge C, Berends FJ, Janssen IM, Bouvy ND, Greve JW. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014 Dec;260(6):984-92. doi: 10.1097/SLA.0000000000000794.

de Jonge C, Rensen SS, Koek GH, Joosten MF, Buurman WA, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves plasma parameters of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1517-20. doi: 10.1016/j.cgh.2013.07.029. Epub 2013 Aug 3.

Layout table for additonal information

Responsible Party:	GI Dynamics
ClinicalTrials.gov Identifier:	NCT00985114
Other Study ID Numbers:	07-1
First Submitted:	September 25, 2009
First Posted:	September 28, 2009
Results First Submitted:	March 20, 2016
Results First Posted:	October 3, 2016
Last Update Posted:	October 3, 2016

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