Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT01841359Other idJoslin 08-34

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 22 participants (actual)
Sponsor: Joslin Diabetes Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 2 Feb 2010
Primary completion: Jul 2016
Completion: 8 Feb 2022
First posted: 26 Apr 2013 (estimated)
Last update posted: 29 Jun 2023
Conditions: Hypoglycemia · Evidence of Previous Gastric Surgery

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020152020

Ph 4
Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery
NCT01841359
2 Feb 2010 to 8 Feb 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PramlintideDrug

Arms2

No intervention
Baseline
Baseline Arm/Phase 1, is comprised of study visits 1 and 2. Visit 1: Screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms, concurrent with a 3 day period of blinded (masked) continuous glucose monitoring device wear. Visit 2: a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom logs were reviewed.
Experimental
Pramlintide
At the end of Visit 2 (following the baseline mixed meal tolerance test), pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During the treatment phase (8 weeks), the participants were asked to keep record of all hypoglycemic symptoms and blood glucose measurements.. Visit 3: (week 4 of treatment) focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days with concurrent wear of a blinded (masked) continuous glucose monitoring device. Visit 4: (week 8 of treatment), participants received a dose of pramlintide 15 minutes prior to undergoing a repeat mixed meal tolerance test. (the dose administered was the maximally tolerated dose of pramlintide used during the 8 week outpatient treatment phase).

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Registry description
Baseline and post-treatment with pramlintide mixed meal testing plasma glucose values, area under the curve (AUC), calculated with the trapezoidal method. Plasma glucose was measured at timepoints (minutes): -5 (baseline), 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes.

Secondary outcomes(10)

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)
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)
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)
Registry description
Assessment of clinical response to pramlintide treatment, as indicated by paired comparison of the frequency of glucose values under 70 mg/dl (expressed as percentage of time) assessed by continuous glucose monitoring.
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.
Registry description
Pre- and post-treatment mixed meal testing plasma insulin levels area under the curve (AUC) was calculated with the trapezoidal method. Plasma insulin was measured at timepoints (minutes): -5 (baseline), 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes.
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.
Registry description
Satiety was analyzed using a visual analogue scale (1, very hungry to 10, not hungry), administered 120 minutes following ingestion of mixed meal.
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.
Registry description
Dumping score was calculated using changes in pulse and hematocrit. Higher scores indicate more severe dumping. Scores ranged from -196 to 186.
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)
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.
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.
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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.

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

Group	Value (mg*min/dL)	Spread
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	2828	3255
Pramlintide - Mixed Meal #2	2893	2770

Secondary and other outcome results(7)

Secondary outcomeMean· 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)

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

Group	Value (mg/dL)	Spread
Baseline (Prior to Treatment With Pramlintide) CGM #1	172	50.98
Pramlintide CGM #2	188	43.6

Secondary outcomeMean· 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)

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

Group	Value (mg/dL)	Spread
Baseline (Prior to Treatment With Pramlintide) CGM #1	54	14.68
Pramlintide CGM #2	56.6	11.44

Secondary outcomeMean· 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)

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

Group	Value (percent time sensor glucose less than 70)	Spread
Baseline (Prior to Treatment With Pramlintide) CGM #1	8.85	9.23
Pramlintide CGM #2	5.60	5.32

Secondary outcomeGeometric mean· 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.

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

Group	Value (uIU*min/mL)	Spread
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	3393	2155
Pramlintide - Mixed Meal #2	3501	2683

Secondary outcomeMean· 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.

Satiety Score During Mixed Meal Testing at 120 Minutes

Group	Value (satiety score)	Spread
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	4.57	3.05
Pramlintide - Mixed Meal #2	5.43	2.51

Secondary outcomeMean· 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.

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

Group	Value (dumping score)	Spread
Baseline (Prior to Pramlintide Treatment) Mixed Meal #1	28.89	101.81
Pramlintide - Mixed Meal #2	72.04	70.93

Secondary outcomeMean· 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)

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

Group	Value (days)	Spread
Baseline (Prior to Treatment With Pramlintide) CGM #1	1.31	1.49
Pramlintide CGM #2	0.56	0.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pramlintide (Symlin)Participants in this study were asked to complete 4 study visits. Study visit 1 was a screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom log was reviewed. Pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times. Study visit 3 occured at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat mixed meal tolerance test. Pramlintide: See description above (arm description).	0 / 22	1 / 22	9 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2022

6 results

Pramlintide for post-bariatric hypoglycaemia.

Sheehan et al. 2022Diabetes, obesity & metabolismcited by 10

PMID 35137513PMC9035096DOI 10.1111/dom.14665PUB-35137513

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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