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

• Sponsor: GI Dynamics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00985114
• Collaborator: (none)
• Enrollment: 77
• Locations: 3
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 25.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.

This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.

The primary efficacy endpoint is:

• Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.

Secondary endpoints are:

• Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.

• Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.

• Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.

• Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.

• Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.

• Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Device: EndoBarrier; Behavioral: Diet + Lifestyle Counseling	N/A

Detailed Description

Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.	Device: EndoBarrier; EndoBarrier implant; Behavioral: Diet + Lifestyle Counseling; Multidisciplinary lifestyle and nutritional counseling
Active Comparator: Diet + Lifestyle counseling Multidisciplinary lifestyle and nutritional counseling for 12 months	Behavioral: Diet + Lifestyle Counseling; Multidisciplinary lifestyle and nutritional counseling

Outcome Measures

Primary Outcome Measures

1. Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years and < 65 years

• Male or Female

• Subjects with Type 2 Diabetes who have been treated for ≤10 years

• BMI> 30 - < 50

• Subjects with an HbA1c level > 7.5 and ≤ 10.0%

• Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30)

• Patients willing to comply with study requirements

• Patients who have signed an informed consent form

Exclusion Criteria:

• Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin

• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis

• Subjects on insulin > 10 years

• Subjects requiring insulin > 70 units per day

• Subjects on pre-mixed insulin (ie. NovoMix 30)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Rijnstate Arnhem	Arnhem		Netherlands
2	Medisch Centrum Parkstad	Heerlen		Netherlands
3	University Hospital Maastricht	Maastricht		Netherlands

Sponsors and Collaborators

• GI Dynamics

Investigators

• Principal Investigator: Jan Willem Greve, MD, University Hospital Masstricht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GI Dynamics
• ClinicalTrials.gov Identifier: NCT00985114
• Other Study ID Numbers: 07-1
• First Posted: Sep 28, 2009
• Last Update Posted: Oct 3, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by GI Dynamics: Type II Diabetes; Obesity
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	EndoBarrier Device	Diet + Lifestyle Counseling
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	39
Diet + Lifestyle Counseling Cross-over	0	28
COMPLETED	33	37
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Device	Diet + Lifestyle Counseling	Total
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 Participants	34	39	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (9.1)	49.3 (7.8)	49.3 (8.3)
Sex: Female, Male (Count of Participants)
Female	13 38.2%	14 35.9%	27 37%
Male	21 61.8%	25 64.1%	46 63%
Region of Enrollment (participants) [Number]
Netherlands	34 100%	39 100%	73 100%
Baseline weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device	Diet + Lifestyle Counseling
Arm/Group Description	EndoBarrier EndoBarrier: EndoBarrier implant	Multidisciplinary lifestyle and nutritional counseling Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
Measure Participants	33	36
Number [% of participants]	81.8 240.6%	61.1 156.7%

Adverse Events

Arm/Group Title	Device and Cross Over		Diet + Lifestyle Counseling
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Device and Cross Over		Diet + Lifestyle Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/66 (27.3%)		4/39 (10.3%)
Cardiac disorders
Pericarditis	1/66 (1.5%)	1	1/39 (2.6%)	1
Myocardial infarction	0/66 (0%)	0	1/39 (2.6%)	1
Gastrointestinal disorders
Abdominal pain upper	5/66 (7.6%)	5	0/39 (0%)	0
Abdominal pain lower	4/66 (6.1%)	4	0/39 (0%)	0
Abdominal pain	1/66 (1.5%)	1	0/39 (0%)	0
Diverticulitis	1/66 (1.5%)	1	0/39 (0%)	0
Melena	1/66 (1.5%)	1	0/39 (0%)	0
Abdominal discomfort	1/66 (1.5%)	1	0/39 (0%)	0
Vomiting	1/66 (1.5%)	1	0/39 (0%)	0
Constipation	1/66 (1.5%)	1	0/39 (0%)	0
Pylorospasm	1/66 (1.5%)	1	0/39 (0%)	0
Hepatobiliary disorders
Cholelithiasis	1/66 (1.5%)	1	1/39 (2.6%)	1
Injury, poisoning and procedural complications
Accidental Overdose	0/66 (0%)	0	1/39 (2.6%)	1
Procedural Nausea	2/66 (3%)	2	0/39 (0%)	0
Procedural Vomiting	2/66 (3%)	2	0/39 (0%)	0
Metabolism and nutrition disorders
Hypoglycemia	0/66 (0%)	0	1/39 (2.6%)	1
Dehydration	1/66 (1.5%)	1	0/39 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	0/66 (0%)	0	1/39 (2.6%)	1
Scapula fracture	0/66 (0%)	0	1/39 (2.6%)	1
Acute hernia	0/66 (0%)	0	1/39 (2.6%)	1
Arthralgia	1/66 (1.5%)	1	0/39 (0%)	0
Back pain	1/66 (1.5%)	1	0/39 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney carcinoma	0/66 (0%)	0	1/39 (2.6%)	1
Metastases to spine	1/66 (1.5%)	1	0/39 (0%)	0
Psychiatric disorders
Mental disorder	0/66 (0%)	0	1/39 (2.6%)	1
Renal and urinary disorders
Urinary incontinence	0/66 (0%)	0	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Device and Cross Over		Diet + Lifestyle Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/66 (83.3%)		25/39 (64.1%)
Gastrointestinal disorders
Abdominal pain upper	31/66 (47%)	47	4/39 (10.3%)	4
Abdominal discomfort	4/66 (6.1%)	4	0/39 (0%)	0
Abdominal pain	11/66 (16.7%)	15	0/39 (0%)	0
Abdominal pain lower	13/66 (19.7%)	20	1/39 (2.6%)	1
Constipation	14/66 (21.2%)	15	4/39 (10.3%)	4
Diarrhea	4/66 (6.1%)	4	3/39 (7.7%)	3
Nausea	14/66 (21.2%)	21	6/39 (15.4%)	6
Vomiting	8/66 (12.1%)	11	4/39 (10.3%)	4
Procedural vomiting	8/66 (12.1%)	8	1/39 (2.6%)	1
Immune system disorders
Hypersensitivity	0/66 (0%)	0	2/39 (5.1%)	2
Infections and infestations
Nasopharyngitis	3/66 (4.5%)	3	3/39 (7.7%)	3
Pneumonia	1/66 (1.5%)	2	2/39 (5.1%)	2
Injury, poisoning and procedural complications
Procedural nausea	17/66 (25.8%)	18	0/39 (0%)	0
Metabolism and nutrition disorders
Hypoglycemia	14/66 (21.2%)	48	11/39 (28.2%)	11
Hypovitaminosis	4/66 (6.1%)	4	0/39 (0%)	0
Iron deficiency	18/66 (27.3%)	22	10/39 (25.6%)	10
Hyperglycemia	0/66 (0%)	0	2/39 (5.1%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	4/66 (6.1%)	5	3/39 (7.7%)	3
Back pain	4/66 (6.1%)	6	1/39 (2.6%)	1
Pain in extremity	0/66 (0%)	0	3/39 (7.7%)	3
Nervous system disorders
Headache	4/66 (6.1%)	4	1/39 (2.6%)	1

Limitations/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.