Study Stopped
Difficulty recruiting patients
Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY
1 other identifier
interventional
1
1 country
1
Brief Summary
The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 14, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 5, 2018
January 1, 2018
2 years
May 10, 2012
January 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Type 2 diabetes remission
Hemoglobin a1c will be used to assess type 2 diabetes remission.
baseline, 1 and 4 months post-randomization
Secondary Outcomes (3)
Whole body insulin sensitivity
baseline, 1 and 4 months post-randomization
GLP-1 response
Baseline, 1 and 4 months post-randomization
First Phase Insulin secretion
Baseline, 1 and 4 months post-randomization
Study Arms (3)
Liraglutide only
ACTIVE COMPARATOROrlistat only
ACTIVE COMPARATORLiraglutide + Orlistat
ACTIVE COMPARATORInterventions
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily.
Orlistat will be started initially at a dose of 60 mg taken with the evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day and the patients will be advised to take a multivitamin 2 hours before or after Orlistat addition to ensure adequate nutrition.
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily. Patients not tolerating a higher dose will be allowed to remain on the lower dose as long they tolerate the lower. Following titration of Liraglutide to a maximum tolerated dose, Orlistat will be started initially at a dose of 60 mg taken with evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day.
Eligibility Criteria
You may qualify if:
- Subjects will be eligible if they meet the following criteria:
- male or female,
- age 25-70 years,
- BMI 26-65,
- type 2 diabetic,
- weight stable for 3 months,
- status post laparoscopic adjustable gastric banding (LAGB) for at least 1 year,
- hemoglobin a1c 7-10%;
- on any diabetic regimen including insulin except for thiazolidinedione use in the past 6 months.
You may not qualify if:
- Subjects will be excluded if they meet any of the following criteria:
- prior history of pancreatitis,
- prior history of gastroparesis,
- glomerular filtration rate (GFR) \< 50,
- history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer,
- history of cholelithiasis,
- history of hyperoxaluria or calcium oxalate nephrolithiasis,
- abnormal AST,
- ALT elevation,
- current or past history of liver disease,
- history of Roux-en-y gastric bypass or gastric sleeve or any other bariatric procedure other than LAGB,
- type 1 diabetes,
- any gastrointestinal disease causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue),
- prior history of Orlistat or incretin therapy use in past 3 months,
- unwilling or unable to complete scheduled testing,
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 28590, United States
Related Publications (1)
Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
PMID: 19272486BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 14, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 5, 2018
Record last verified: 2018-01