GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01841359

CompletedPhase 4Results posted

Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Lead sponsor

Joslin Diabetes Center

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Bariatric Surgery

Key I/E criterion

—

Primary endpoint

•Postprandial glucose

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 IDNCT01841359

Org study IDJoslin 08-34

Timeline

Milestones

Study start2010-02-02actual

Study first posted2013-04-26estimated

Study completion2022-02-08actual

Results first posted2022-05-26actual

Last update posted2023-06-29actual

Primary completion2016-07actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Bariatric Surgery

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•severe hypoglycemic episodes post-gastric bypass surgery

•normal fasting glucose

•age 21 to 65

•hypoglycemia must not have responded to dietary intervention (low glycemic index, controlled carbohydrate portions) and a trial of acarbose therapy at the maximally tolerated dose

Exclusion criteria

•Hypoglycemia in the fasting state (greater than 12 hours fast)

•History of preoperative diabetes mellitus

•Use of medications that affect gastrointestinal motility (e.g., cisapride, metoclopramide)

•Impaired renal function (creatinine clearance < 20 ml/min or on dialysis

•Hepatic disease (defined as liver enzymes > 2 times upper normal limit for alanine transaminase (ALT) and aspartate aminotransferase (AST))

•Blood donation for 2 months prior to the study.

•Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or neuroglycopenic symptoms of hypoglycemia despite detailed education

Endpoints (11)

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

Safety / tolerability / PK

Patient-reported / QoL

Other clinical outcomes

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose

Time frame:Levels assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (geometric_mean), mg*min/dL	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	2828	—
Pramlintide - Mixed Meal #2	2893	—

p0.90Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Continuous Glucose Monitoring Maximum Sensor Glucose Values Prior to (Baseline) and During Pramlintide Therapy.

Time frame:During 8 week period of participation, V1-V2 (baseline CGM data over 3 days); V3-V4 (CGM data during treatment with three times per day (TID) pramlintide over 3 days)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Baseline (Prior to Treatment With Pramlintide) CGM #1	172	—
Pramlintide CGM #2	188	—

p0.08t-test, 2 sided

Secondary/protocol endpoint/low confidence

Continuous Glucose Monitoring Minimum Sensor Glucose Prior to (Baseline) and During Pramlintide Therapy.

Time frame:During 8 week period of participation, V1-V2 (baseline CGM data over 3 days); V3-V4 (CGM data during treatment with TID pramlintide over 3 days)

CGM time-below-range

descriptive, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Baseline (Prior to Treatment With Pramlintide) CGM #1	54	—
Pramlintide CGM #2	56.6	—

p= 0.20492t-test, 2 sided

Secondary/protocol endpoint

Hypoglycemia - Percentage of Time Sensor Glucose Levels < 70 mg/dL Prior to (Baseline) and During Pramlintide Therapy.

Time frame:During 8 week period of participation, V1-V2 (baseline CGM data over 3 days); V3-V4 (CGM data during treatment with TID pramlintide over 3 days)

CGM time-below-range

percent change from baseline, improvement

Posted result

Group	Value (mean), percent time sensor glucose less than 70	95% CI
Baseline (Prior to Treatment With Pramlintide) CGM #1	8.85	—
Pramlintide CGM #2	5.60	—

p0.2655t-test, 2 sided

Secondary/protocol endpoint

Plasma Insulin Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Insulin

Time frame:Levels assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

concentration, descriptive

Posted result

Group	Value (geometric_mean), uIU*min/mL	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	3393	—
Pramlintide - Mixed Meal #2	3501	—

p0.64Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Nadir Plasma Glucose Levels During Mixed Meal Testing at Baseline and During Treatment With Pramlintide

Time frame:Levels assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

descriptive

Posted result

Group	Value (mean), mg/dL	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	67.18	—
Pramlintide - Mixed Meal #2	69.9	—

p0.412t-test, 2 sided

Secondary/protocol endpoint

Time to Nadir Plasma Glucose During Mixed Meal Testing at Baseline and During Treatment With Pramlintide

Time frame:Assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

descriptive

Posted result

Group	Value (mean), minutes	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	64.29	—
Pramlintide - Mixed Meal #2	66.43	—

p0.890t-test, 2 sided

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Satiety Score During Mixed Meal Testing at 120 Minutes

Time frame:Levels assessed on the two days of mixed meal testing at the 120 min time point: the first occurring at baseline (prior to treatment with pramlintide), and the second following 8 weeks of treatment with pramlintide.

change from baseline, improvement

Posted result

Group	Value (mean), satiety score	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	4.57	—
Pramlintide - Mixed Meal #2	5.43	—

p0.597t-test, 2 sided

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Days With Minimum Sensor Glucose < 54 mg/dL as Measured by Continuous Glucose Monitoring.

Time frame:During 8 week period of participation, V1-V2 (baseline CGM data over 3 days); V3-V4 (CGM data during treatment with TID pramlintide over 3 days)

CGM time-below-range

event count, event

Posted result

Group	Value (mean), days	95% CI
Baseline (Prior to Treatment With Pramlintide) CGM #1	1.31	—
Pramlintide CGM #2	0.56	—

p0.14t-test, 2 sided

Secondary/protocol endpoint

Number of Participants Requiring Rescue Treatment for Severe Hypoglycemia During Mixed Meal Testing (Visit 2 Baseline vs. Visit 4 Post-pramlintide Dosing)

Time frame:Assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

Severe hypoglycemia

event count, event

Posted result

Group	Value (number), number of participants	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	6	—
Pramlintide - Mixed Meal #2	4	—

p0.69Fisher Exact

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Dumping Score During Mixed Meal Testing at Baseline and During Treatment With Pramlintide

Time frame:Levels assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide.

change from baseline, improvement

Posted result

Group	Value (mean), dumping score	95% CI
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	28.89	—
Pramlintide - Mixed Meal #2	72.04	—

p0.37t-test, 2 sided

Publications (4)

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

Pramlintide for post-bariatric hypoglycaemia.
Diabetes, obesity & metabolism2022 Jun (month)PMID35137513doi:10.1111/dom.14665via CT.gov background
Hypoglycaemia following gastric bypass surgery--diabetes remission in the extreme?
Diabetologia2010 Nov (month)PMID20730413doi:10.1007/s00125-010-1884-8via CT.gov background
Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal.
The Journal of clinical endocrinology and metabolism2007 Dec (month)PMID17895322doi:10.1210/jc.2007-0918via CT.gov background
Severe hypoglycaemia post-gastric bypass requiring partial pancreatectomy: evidence for inappropriate insulin secretion and pancreatic islet hyperplasia.
Diabetologia2005 Nov (month)PMID16195867doi:10.1007/s00125-005-1933-xvia CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.