Type 2 DiabetesPhase 4NCT01597531
Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
A Phase 4 study testing Liraglutide, Orlistat and Liraglutide + Orlistat in people with Type 2 Diabetes and Gastric Banding, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Gastric Banding
- What is being tested?
- Liraglutide, Orlistat and Liraglutide + Orlistat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 28590
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Gastric Banding
- Being tested
- Liraglutide, Orlistat, Liraglutide + Orlistat
- Keywords
- Liraglutide, Orlistat
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
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.
OrlistatDrug
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 + OrlistatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide only | Active comparator | Not described Receives: Drug: Liraglutide |
| Orlistat only | Active comparator | Not described Receives: Drug: Orlistat |
| Liraglutide + Orlistat | Active comparator | Not described Receives: Drug: Liraglutide + Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes remission
Hemoglobin a1c will be used to assess type 2 diabetes remission.
Measured: baseline, 1 and 4 months post-randomization
Secondary outcomes (3)
Whole body insulin sensitivity
Minimal model testing will be used to assess whole body insulin sensitivity.
Measured: baseline, 1 and 4 months post-randomization
GLP-1 response
A mixed meal challenge will be used to assess meal-stimulated GLP-1 response.
Measured: Baseline, 1 and 4 months post-randomization
First Phase Insulin secretion
Minimal model testing will be used to assess first phase insulin secretion.
Measured: Baseline, 1 and 4 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moahad S Dar, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597531
- Sponsor's protocol ID
- ECDOI-D71
- Status last verified
- Jan 2018
- First submitted
- 10 May 2012
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19272486
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY
- ClinicalTrials.gov ID
- NCT01597531
- Acronym / sponsor ID
- ECDOI-D71
- Conditions
- Type 2 Diabetes, Gastric Banding
- Keywords
- Liraglutide, Orlistat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide only | Active comparator | Drug: Liraglutide |
| Orlistat only | Active comparator | Drug: Orlistat |
| Liraglutide + Orlistat | Active comparator | Drug: Liraglutide + Orlistat |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female,
- age 25-70 years,
- BMI 26-65,
- type 2 diabetic,
- weight stable for 3 months,
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideLiraglutide 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. | Drug | Liraglutide only |
| OrlistatOrlistat 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. | Drug | Orlistat only |
| Liraglutide + OrlistatLiraglutide 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. | Drug | Liraglutide + Orlistat |
Primary outcome
Type 2 diabetes remission
Time frame: baseline, 1 and 4 months post-randomization
Hemoglobin a1c will be used to assess type 2 diabetes remission.
3 secondary outcomes
Whole body insulin sensitivity
Time frame: baseline, 1 and 4 months post-randomization
GLP-1 response
Time frame: Baseline, 1 and 4 months post-randomization
First Phase Insulin secretion
Time frame: Baseline, 1 and 4 months post-randomization
Results and safety
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 19272486Buchwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide, Orlistat and Liraglutide + Orlistat in people with Type 2 Diabetes and Gastric Banding, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes remission (time frame: baseline, 1 and 4 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01597531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.