Phase 4 N=22 Treatment

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

Hypoglycemia · Evidence of Previous Gastric Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01841359 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

May 2022

Primary outcome: Primary: Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose — 2828; 2893 mg*min/dL — p=0.90

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pramlintide (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Joslin Diabetes Center
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose	2828; 2893	0.90
SECONDARY Continuous Glucose Monitoring Maximum Sensor Glucose Values Prior to (Baseline) and During Pramlintide Therapy.	172; 188	0.08
SECONDARY Continuous Glucose Monitoring Minimum Sensor Glucose Prior to (Baseline) and During Pramlintide Therapy.	54; 56.6	= 0.20492
SECONDARY Hypoglycemia - Percentage of Time Sensor Glucose Levels < 70 mg/dL Prior to (Baseline) and During Pramlintide Therapy.	8.85; 5.60	0.2655
SECONDARY Plasma Insulin Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Insulin	3393; 3501	0.64
SECONDARY Satiety Score During Mixed Meal Testing at 120 Minutes	4.57; 5.43	0.597
SECONDARY Dumping Score During Mixed Meal Testing at Baseline and During Treatment With Pramlintide	28.89; 72.04	0.37
SECONDARY Number of Days With Minimum Sensor Glucose < 54 mg/dL as Measured by Continuous Glucose Monitoring.	1.31; 0.56	0.14
SECONDARY Nadir Plasma Glucose Levels During Mixed Meal Testing at Baseline and During Treatment With Pramlintide	67.18; 69.9	0.412
SECONDARY Time to Nadir Plasma Glucose During Mixed Meal Testing at Baseline and During Treatment With Pramlintide	64.29; 66.43	0.890
SECONDARY Number of Participants Requiring Rescue Treatment for Severe Hypoglycemia During Mixed Meal Testing (Visit 2 Baseline vs. Visit 4 Post-pramlintide Dosing)	6; 4	0.69

Summary

The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce the frequency and severity of hypoglycemia in individuals who have had gastric bypass surgery.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01841359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.