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Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Primary Purpose

Type 2 Diabetes, Gastric Banding

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liraglutide

Orlistat

Liraglutide + Orlistat

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Liraglutide, Orlistat

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Brody School of Medicine at East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Liraglutide only

Orlistat only

Liraglutide + Orlistat

Arm Description

Outcomes

Primary Outcome Measures

Type 2 diabetes remission

Hemoglobin a1c will be used to assess type 2 diabetes remission.

Secondary Outcome Measures

Whole body insulin sensitivity

Minimal model testing will be used to assess whole body insulin sensitivity.

GLP-1 response

A mixed meal challenge will be used to assess meal-stimulated GLP-1 response.

First Phase Insulin secretion

Minimal model testing will be used to assess first phase insulin secretion.

Full Information

NCT ID

NCT01597531

First Posted

May 10, 2012

Last Updated

January 31, 2018

Sponsor

East Carolina University

1. Study Identification

Unique Protocol Identification Number

NCT01597531

Brief Title

Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

Difficulty recruiting patients

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

East Carolina University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Gastric Banding

Keywords

Liraglutide, Orlistat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide only

Arm Type

Active Comparator

Arm Title

Orlistat only

Arm Type

Active Comparator

Arm Title

Liraglutide + Orlistat

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Orlistat

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Liraglutide + Orlistat

Intervention Description

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.

Primary Outcome Measure Information:

Title

Type 2 diabetes remission

Description

Hemoglobin a1c will be used to assess type 2 diabetes remission.

Time Frame

baseline, 1 and 4 months post-randomization

Secondary Outcome Measure Information:

Title

Whole body insulin sensitivity

Description

Minimal model testing will be used to assess whole body insulin sensitivity.

Time Frame

baseline, 1 and 4 months post-randomization

Title

GLP-1 response

Description

A mixed meal challenge will be used to assess meal-stimulated GLP-1 response.

Time Frame

Baseline, 1 and 4 months post-randomization

Title

First Phase Insulin secretion

Description

Minimal model testing will be used to assess first phase insulin secretion.

Time Frame

Baseline, 1 and 4 months post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Brody School of Medicine at East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

28590

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19272486

Citation

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.

Results Reference

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Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

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