DelfaGLP-1 Atlas

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CompletedPhase 1

Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

A Pilot Study Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia Post-RYGB

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

11

actual

Study population

Bariatric Surgery

Key I/E criterion

—

Primary endpoints

•Postprandial glucose•Documented hypoglycemia

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 IDNCT02685852
Org study ID1503M65841

Timeline

Milestones

Study first posted2016-02-19estimated
Primary completion2019-07-22actual
Study completion2019-07-22actual
Last update posted2021-05-06actual
Study start2016-02 (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Bariatric Surgery

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. must have undergone RYGB and subsequently developed post-prandial hypoglycemia (defined as at least 3 episodes over a six-month period with documented capillary blood sugars [<60 mg/dL with hypoglycemic symptoms). Subjects may also have had a formal mixed meal tolerance test with post meal blood sugar <60 mg/dL.

2. Subjects who otherwise meet the study criteria above with hypoglycemia symptoms but who do not have documented hypoglycemia by plasma measurement may undergo a screening visit to document the requisite levels for consideration into the study.

Exclusion criteria

1. Chronic or acute diseases of the liver.

2. Chronic or acute diseases of the pancreas (including type 1 diabetes or pancreatitis or a history of pancreatitis). Subjects may have a diagnosis of type 2 diabetes but must no longer require diabetes medication.

3. Chronic or acute diseases of the kidneys.

4. Known malignancies and must not have a family history of medullary thyroid cancer.

5. History of pre-RYGB hypoglycemia symptoms or low documented plasma glucose preoperatively.

6. Pregnant or plans to become pregnant throughout study duration

7. Breastfeeding

8. Medication exclusions in addition to the current use of diabetes medications. Subjects will be excluded if they have previously taken GLP-1 agonists.

Endpoints (5)

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
4
Safety / tolerability / PK
1

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Glucose area under the curve (AUC) following treatment for each 4-hour test period

Time frame:During the 4-hour test period

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Minimum post-prandial blood sugar level (mg/dL)

Time frame:post meal test

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Change in post-prandial blood glucose from 0min to 120min

Time frame:0min to 120min

Postprandial glucose

percent change from baseline, improvement

Secondary/protocol endpoint

Change in post-prandial Insulin levels (mcg/mL)

Time frame:0min to 120min

percent change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Presence of hypoglycemia

Time frame:15, 30, 45, 60, 90, 120, 180 and 240 minutes

Documented hypoglycemia

threshold achievement, event

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.