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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
This study is an open-label short-term proof of concept study. The investigators will administer pramlintide to patients with severe post-prandial hypoglycemia following gastric bypass, in order to determine whether pramlintide is effective in reducing the frequency or severity of hypoglycemia. Pramlintide will be prescribed for 8 weeks. In order to assess the efficacy of pramlintide to prevent post-prandial hypoglycemia and hypoglycemic symptoms, the investigators will compare (a) blood glucose measurements and frequency of hypoglycemic symptoms, before and at the end of the drug intervention, using both capillary glucose monitoring and continuous glucose monitoring, and (b) glycemic, hormonal, and energetic responses to a three-hour mixed meal tolerance test.
The study will utilize an open label design to evaluate the efficacy of pramlintide in patients who have had gastric bypass and have severe postprandial hypoglycemia. The study will not be randomized or blinded. The investigators will recruit 26 participants from Joslin Diabetes Center.
Briefly, participants in this study will be asked to complete 4 study visits. The first visit will be for screening. They will then be asked to keep a 3-day log in which they record food intake (including estimated portion sizes), blood glucoses eight times daily, as well as any hypoglycemic symptoms, before they initiate treatment. Concurrently participants will wear a professional (blinded) continuous glucose monitoring (CGM) device for 3 days. At a second study visit, they will undergo a mixed meal tolerance test, which will serve as a baseline evaluation. Patterns of (a) glucose excursions (initial postprandial peak, subsequent postprandial fall and potential hypoglycemia), and (b) hormonal responses (insulin, C-peptide, glucagon, incretins) will be assessed. At the end of the mixed meal, satiety will be assessed using a visual analog scale. Baseline hypoglycemia frequency and severity will be assessed by reviewing patient glucose and hypoglycemia symptom log recorded prior to the visit.
At the completion of visit 2, pramlintide will be prescribed, with instructions for titration of the drug from minimal to maximal dose (see titration schedule below) to help reduce the incidence of side effects. During the treatment period, the participants will keep a record of all hypoglycemic symptoms and blood glucose measurements at those times.
There will be one follow-up visit (visit 3) in the middle of the treatment period for evaluation of symptoms and tolerance of medication. During the last (eighth) week of treatment, for comparison with pre-treatment glycemia, participants will again complete a food diary, and measure and record blood glucoses eight times daily for 3 days, while also wearing a professional (blinded) CGM. During that final week of the study, participants will also come to a fourth study visit, during which they will undergo a repeat mixed meal tolerance test, receiving a dose of pramlintide prior to the start of the mixed meal, for comparison with the pre-treatment (baseline) results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | No Intervention | 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. | |
| Pramlintide | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide | Drug | See description above (arm description). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitoring Maximum Sensor Glucose Values Prior to (Baseline) and During Pramlintide Therapy. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E. Patti, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20730413 | Background | Patti ME, Goldfine AB. Hypoglycaemia following gastric bypass surgery--diabetes remission in the extreme? Diabetologia. 2010 Nov;53(11):2276-9. doi: 10.1007/s00125-010-1884-8. Epub 2010 Aug 21. | |
| 17895322 | Background | Goldfine AB, Mun EC, Devine E, Bernier R, Baz-Hecht M, Jones DB, Schneider BE, Holst JJ, Patti ME. Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal. J Clin Endocrinol Metab. 2007 Dec;92(12):4678-85. doi: 10.1210/jc.2007-0918. Epub 2007 Sep 25. |
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Participants with post-bariatric hypoglycemia (PBH) following gastric bypass were recruited from outpatient clinics at Joslin Diabetes Center, Boston, Massachusetts for an open label study of pramlintide efficacy over 8 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis is based upon 14 participants who completed the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pramlintide (Symlin) | Participants in this study completed 4 study visits. Study visit 1 was a screening visit. Participants kept 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 were 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 occurred 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose | 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. | Analysis was for the 14 participants who completed all study visits. | Posted | Geometric Mean | Standard Deviation | mg*min/dL | 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. |
|
For each participant, adverse event data was collected during their 8 week period of participation. Overall, the participant data was collected from April 2014 through May 2016.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration (r/t diarrhea) | General disorders | Non-systematic Assessment | Not related to study drug / procedures (onset was prior to study drug initiation). Pt was hospitalized 24 hrs. Resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Baseline (pre-study drug start) hypoglycemia (n=2) During study drug treatment hypoglycemia (n=2) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Elizabeth Patti, MD | Joslin Diabetes Center | 6173092635 | MaryElizabeth.Patti@joslin.harvard.edu |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
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Participants in this study were asked to complete 4 study visits.
Arm/Phase 1: Baseline: Study V1 was a screening visit. Participants kept a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At V2, a baseline mixed meal tolerance test (MMTT) was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom logs were reviewed.
Arm / Phase 2: Pramlintide treatment Pramlintide was prescribed at the end of visit 2 (following MMTT), 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 occurred 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 MMTT.
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| 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. | 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. | 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) |
| Plasma Insulin Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Insulin | 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. | 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. |
| Satiety Score During Mixed Meal Testing at 120 Minutes | Satiety was analyzed using a visual analogue scale (1, very hungry to 10, not hungry), administered 120 minutes following ingestion of mixed meal. | 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. |
| Dumping Score During Mixed Meal Testing at Baseline and During Treatment With Pramlintide | Dumping score was calculated using changes in pulse and hematocrit. Higher scores indicate more severe dumping. Scores ranged from -196 to 186. | 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. |
| Number of Days With Minimum Sensor Glucose < 54 mg/dL as Measured by Continuous Glucose Monitoring. | 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 | 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 | 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) | Assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide. |
| 16195867 | Background | Patti ME, McMahon G, Mun EC, Bitton A, Holst JJ, Goldsmith J, Hanto DW, Callery M, Arky R, Nose V, Bonner-Weir S, Goldfine AB. Severe hypoglycaemia post-gastric bypass requiring partial pancreatectomy: evidence for inappropriate insulin secretion and pancreatic islet hyperplasia. Diabetologia. 2005 Nov;48(11):2236-40. doi: 10.1007/s00125-005-1933-x. Epub 2005 Sep 30. |
| Background | Goldfine AB, Mun E, Patti ME. Hyperinsulinemic hypoglycemia following gastric bypass surgery for obesity. Current Opinion in Endocrinology and Diabetes 13: 419-24, 2006. |
| 35137513 | Background | Sheehan A, Goldfine A, Bajwa M, Wolfs D, Kozuka C, Piper J, Fowler K, Patti ME. Pramlintide for post-bariatric hypoglycaemia. Diabetes Obes Metab. 2022 Jun;24(6):1021-1028. doi: 10.1111/dom.14665. Epub 2022 Mar 9. |
| Did not receive study drug at visit 4 prior to mixed meal testing |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-operative BMI | Mean | Standard Deviation | kg/m^2 |
|
| Current BMI | Mean | Standard Deviation | kg/m^2 |
|
| Onset of hypoglycemia (years since) surgery | Mean | Standard Deviation | years |
|
| Time Since RYGB (years) | Mean | Standard Deviation | years |
|
| Preoperative history of diabetes mellitus (DM) or gestational DM | Count of Participants | Participants |
|
| Family history of DM in first-degree relative | Count of Participants | Participants |
|
| Possible hypoglycemia symptoms present preoperatively (self-report) | Count of Participants | Participants |
|
| Hypoglycemia frequency (self-report) - Daily or more | Count of Participants | Participants |
|
| Hypoglycemia frequency (self-report) - Weekly or more (but not daily) | Count of Participants | Participants |
|
| Hypoglycemia frequency (self-report) - Monthly or more (but not weekly) | Count of Participants | Participants |
|
| Systolic Blood Pressure Supine | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure Supine | Mean | Standard Deviation | mmHg |
|
| Cholesterol (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Triglycerides (mg/dl) | Mean | Standard Deviation | mg/dL |
|
| HDL (mg/dl) | Mean | Standard Deviation | mg/dL |
|
| Current therapy with acarbose | Count of Participants | Participants |
|
| Current therapy with diazoxide | Count of Participants | Participants |
|
| Current therapy with octreotide | Count of Participants | Participants |
|
| Current therapy - medical nutrition therapy alone | Count of Participants | Participants |
|
| OG001 |
| Pramlintide - Mixed Meal #2 |
Mixed meal #2 performed after 1 dose of pramlintide given 15 minutes prior to the mixed meal, at maximum tolerated dose achieved during the outpatient stage. |
|
|
|
| Secondary | Continuous Glucose Monitoring Maximum Sensor Glucose Values Prior to (Baseline) and During Pramlintide Therapy. | Analysis was for the participants with available CGM data who completed all study visits in this sequential design. Note that the number of participants analyzed for CGM related outcomes differs from the number of participants analyzed in the other outcomes due to incomplete CGM data. | Posted | Mean | Standard Deviation | mg/dL | 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) |
|
|
|
|
| Secondary | Continuous Glucose Monitoring Minimum Sensor Glucose Prior to (Baseline) and During Pramlintide Therapy. | Analysis was for the participants with available CGM data who completed all study visits in this sequential design. Note that the number of participants analyzed for CGM related outcomes differs from the number of participants analyzed in the other outcomes due to incomplete CGM data. | Posted | Mean | Standard Deviation | mg/dL | 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) |
|
|
|
|
| Secondary | Hypoglycemia - Percentage of Time Sensor Glucose Levels < 70 mg/dL Prior to (Baseline) and During Pramlintide Therapy. | 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. | Analysis was for the participants with available CGM data who completed all study visits in this sequential design. Note that the number of participants analyzed for CGM related outcomes differs from the number of participants analyzed in the other outcomes due to incomplete CGM data. | Posted | Mean | Standard Deviation | percent time sensor glucose less than 70 | 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) |
|
|
|
|
| Secondary | Plasma Insulin Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Insulin | 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. | Posted | Geometric Mean | Standard Deviation | uIU*min/mL | 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. |
|
|
|
|
| Secondary | Satiety Score During Mixed Meal Testing at 120 Minutes | Satiety was analyzed using a visual analogue scale (1, very hungry to 10, not hungry), administered 120 minutes following ingestion of mixed meal. | Posted | Mean | Standard Deviation | satiety score | 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. |
|
|
|
|
| Secondary | Dumping Score During Mixed Meal Testing at Baseline and During Treatment With Pramlintide | Dumping score was calculated using changes in pulse and hematocrit. Higher scores indicate more severe dumping. Scores ranged from -196 to 186. | Posted | Mean | Standard Deviation | dumping score | 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. |
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|
|
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| Secondary | Number of Days With Minimum Sensor Glucose < 54 mg/dL as Measured by Continuous Glucose Monitoring. | Analysis was for the participants with available CGM data who completed all study visits in this sequential design. Note that the number of participants analyzed for CGM related outcomes differs from the number of participants analyzed in the other outcomes due to incomplete CGM data. | Posted | Mean | Standard Deviation | days | 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) |
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| Secondary | Nadir Plasma Glucose Levels During Mixed Meal Testing at Baseline and During Treatment With Pramlintide | Posted | Mean | Standard Deviation | mg/dL | 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. |
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| Secondary | Time to Nadir Plasma Glucose During Mixed Meal Testing at Baseline and During Treatment With Pramlintide | Posted | Mean | Standard Deviation | minutes | Assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide. |
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| Secondary | Number of Participants Requiring Rescue Treatment for Severe Hypoglycemia During Mixed Meal Testing (Visit 2 Baseline vs. Visit 4 Post-pramlintide Dosing) | Posted | Number | number of participants | Assessed on the two days of mixed meal testing: the first occurring at baseline; and the second following 8 weeks of treatment with pramlintide. |
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|
| 0 |
| 22 |
| 1 |
| 22 |
| 9 |
| 22 |
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| Diarrhea (assoc. with dehydration requiring hospitalization) | Gastrointestinal disorders | Non-systematic Assessment | Associated with dehydration. Not related to study drug / procedures (onset was prior to study drug initiation). Pt was hospitalized 24 hrs. Resolved. |
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|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment | Capillary glucose 450. Related to post-bariatric surgery status (rapid absorption / high peak of glucose levels). |
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| Elevated liver enzymes | Hepatobiliary disorders | Non-systematic Assessment | Alcohol use acknowledged by participant, started on Campral since 10/18/14. Recovered / resolved. |
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| Nausea | General disorders | Non-systematic Assessment | Possibly related to study drug. Pramlintide doses reduced (n=2). Nausea resolved or improved to baseline level of pre-existing nausea. |
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| Altered taste (during treatment with study drug) | General disorders | Non-systematic Assessment | Related. |
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| Ethanol abuse / intoxication | Psychiatric disorders | Non-systematic Assessment | Withdrawn from study, referred for support (AA, detox, alcohol detox specialist). |
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| Trembling | General disorders | Non-systematic Assessment | Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment. |
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| Diarrhea (with urgency and incontinence) | Gastrointestinal disorders | Non-systematic Assessment | Resolved. |
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| Auditory hallucinations | Psychiatric disorders | Non-systematic Assessment | Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment. |
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| Cold feeling behind eyes. | General disorders | Non-systematic Assessment | Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment. |
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| Nightmares | General disorders | Non-systematic Assessment | Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment. |
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| Increase in baseline anxiety. | Psychiatric disorders | Non-systematic Assessment | Withdrawn from study due to multiple symptoms related to treatment. |
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| Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria) | Renal and urinary disorders | Non-systematic Assessment | No abnormal labs at V1/V2. U/A was negative for a urinary tract infection. Recovered without sequelae. |
|
| Cholecystitis (prior to treatment with study drug) | Hepatobiliary disorders | Non-systematic Assessment | Not related. Preexisting condition identified during screening process, patient not enrolled in study at that time. Not related recovered without sequelae. |
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| Sinus infection (Visit 4, following treatment with study drug) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related. Recovered without sequelae. |
|
| Weight loss (during study drug treatment) | General disorders | Non-systematic Assessment | Possibly related. 6.6 lbs in 6 weeks. Related. Study drug dose decreased from 60 mcg to 30 mcg. Recovered without sequelae. |
|
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