Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

University of North Carolina System

Status and phase: Terminated; Phase 4

Conditions: Gastric Banding; Type 2 Diabetes

Treatments: Drug: Liraglutide + Orlistat; Drug: Orlistat; Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01597531

ECDOI-D71

Details and patient eligibility

About

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.

Full description

Liraglutide and Orlistat improve glycemic control by increasing glucagon-like-peptide-1 (GLP-1) response and fat malabsorption, respectively but do not reverse type 2 diabetes. Roux-en-y gastric bypass (RYGB) surgery reverses type 2 diabetes 84% of the time while the less invasive, reversible laparoscopic adjustable gastric banding (LAGB) procedure reverses type 2 diabetes 48% of the time.

Decreased caloric intake occurs after RYGB and LAGB but increased post-prandial GLP-1 response and fat malabsorption only occur after RYGB. Since FDA-approved agents Liraglutide and Orlistat increase GLP-1 response and fat malabsorption, respectively, it is of significant clinical interest to determine if addition of Liraglutide and/or Orlistat can improve type 2 diabetes remission rates in the 52% of patients who have not achieved diabetes reversal after gastric banding.

Enrollment: 1 patient

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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,
• thiazolidinedione use within past 6 months,
• any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study.

Patients who have had organ transplantation are on chronic anticoagulation, pregnant or have A1C values > 10% will also be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Liraglutide only

Active Comparator group

Treatment:

Drug: Liraglutide

Orlistat only

Active Comparator group

Treatment:

Drug: Orlistat

Liraglutide + Orlistat

Active Comparator group

Treatment:

Drug: Liraglutide + Orlistat