Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

January 31, 2018 updated by: Moahad S Dar, East Carolina University

LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 28590
        • Brody School of Medicine at East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liraglutide only
Drug: Liraglutide
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.
Active Comparator: Orlistat only
Drug: Orlistat
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.
Active Comparator: Liraglutide + Orlistat
Drug: Liraglutide + Orlistat
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 diabetes remission
Time Frame: baseline, 1 and 4 months post-randomization
Hemoglobin a1c will be used to assess type 2 diabetes remission.
baseline, 1 and 4 months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole body insulin sensitivity
Time Frame: baseline, 1 and 4 months post-randomization
Minimal model testing will be used to assess whole body insulin sensitivity.
baseline, 1 and 4 months post-randomization
GLP-1 response
Time Frame: Baseline, 1 and 4 months post-randomization
A mixed meal challenge will be used to assess meal-stimulated GLP-1 response.
Baseline, 1 and 4 months post-randomization
First Phase Insulin secretion
Time Frame: Baseline, 1 and 4 months post-randomization
Minimal model testing will be used to assess first phase insulin secretion.
Baseline, 1 and 4 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 14, 2012

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECDOI-D71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe