DelfaGLP-1 Atlas

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TerminatedPhase 4

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

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

1

actual

Study population

Bariatric Surgery, Type 2 diabetes

Key I/E criteria

•BMI 26-65•HbA1c 7-10%

Primary endpoint

•Type 2 diabetes remission

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01597531
Org study IDECDOI-D71

Timeline

Milestones

Study first posted2012-05-14estimated
Last update posted2018-02-05actual
Study start2012-06 (month precision)
Primary completion2014-06actual (month precision)
Study completion2014-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Bariatric SurgeryType 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Type 2 diabetes remission

Time frame:baseline, 1 and 4 months post-randomization

categorical status, improvement

Secondary/protocol endpoint

Whole body insulin sensitivity

Time frame:baseline, 1 and 4 months post-randomization

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

First Phase Insulin secretion

Time frame:Baseline, 1 and 4 months post-randomization

descriptive, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

GLP-1 response

Time frame:Baseline, 1 and 4 months post-randomization

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.