Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`A
`We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
`
`D} U.S. National Library of Medicine
`Clinical Trials.gov
`
`Find Studies
`
`About Studies
`
`Submit Studies
`
`Resources
`
`About Site
`
`PRS Login
`
`Home
`
`>
`
`Search Results
`
`>
`
`Study Record Detail
`
` Save this study
`
`Post-Gastric Bypass Hypoglycemia
`
`A
`
`The safety and scientific validity of
`this study is the responsibility of the
`study sponsor and investigators.
`Listing a study does not mean it has
`been evaluated by the U.S. Federal
`Government. Read our disclaimer
`for details.
`
`Sponsor:
`University of Minnesota
`
`Information provided by (Responsible Party):
`University of Minnesota
`
`ClinicalTrials.gov Identifier: NCT01933490
`
`Recruitment Status  : Completed
`First Posted  : September 2, 2013
`Last Update Posted  : November 1, 2019
`
`View this study on
`Beta.ClinicalTrials.gov
`
`Study Details
`r
`
`l
`
`Tabular View
`
`No Results Posted
`
`Disclaimer
`
`D
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`Brief Summary:
`Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after
`gastric bypass surgery for obesity. The pathogenesis is incompletely understood but involves a robust insulin response
`to ingested carbohydrate. The resultant hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia,
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0001
`
`

`

`Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`confusion and even loss of consciousness. Various treatments have been recommended including low carbohydrate
`diets, coingestion of the medication acarbose with carbohydrate containing meals, partial pancreatectomy and even
`total pancreatectomy. None is completely satisfactory. We propose to test two new potential treatments. Using a design
`with random assignment of three conditions we plan to compare, in 10 patients with post-gastric bypass
`hyperinsulinemic hypoglycemia, a high carbohydrate test meal (control condition), a high carbohydrate test meal after
`pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low glucose test meal with
`carbohydrate and caloric content similar to the control meal (fructose condition).
`
`Condition or
`disease 
`
`Hyperinsulinemic
`Hypoglycemia
`
`Phase 
`
`Not Applicable
`
`Intervention/treatment 
`
`Other: high carbohydrate test meal
`Other: high carbohydrate test meal after pre-treatment
`with rapid acting aspart insulin
`Other: high fructose , low glucose test meal with
`carbohydrate and caloric content similar to the control
`meal
`
`Detailed Description:
`Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after
`gastric bypass surgery for obesity. The pathogenesis is incompletely understood but involves a robust insulin response
`to ingested carbohydrate. The resultant hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia,
`confusion and even loss of consciousness. Various treatments have been recommended including low carbohydrate
`diets, coingestion of the medication acarbose with carbohydrate containing meals, partial pancreatectomy and even
`total pancreatectomy. None is completely satisfactory. We propose to test two new potential treatments. Using a design
`with random assignment of three conditions we plan to compare, in 10 patients with post-gastric bypass
`hyperinsulinemic hypoglycemia, a high carbohydrate test meal (control condition), a high carbohydrate test meal after
`pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low glucose test meal with
`carbohydrate and caloric content similar to the control meal (fructose condition). The hypothesis to be tested are 1)
`pretreatment with aspart insulin will prevent, or at least reduce, the occurrence of hypoglycemia and 2) substitution of
`fructose for glucose in the test meal will prevent, or at least reduce, the occurrence of hypoglycemia. Plasma glucose
`and serum insulin will be sampled before and for four hours after the three test conditions. The primary study endpoint
`will be the occurrence or not of plasma glucose < 60 mg/dL after the test meals. The control meal will be compared to
`the insulin pre-treated test meal and, in a separate comparison, to the fructose test meal. Secondary endpoints will be
`comparisons between the control and active treatments in peak postprandial serum insulin, peak postprandial plasma
`glucose, nadir postprandial plasma glucose, and the 4-hr longitudinal course of plasma glucose measurements.
`
`Study Design
`
`Go to
`
`Interventional (Clinical Trial)
`Study Type  :
`Actual Enrollment  : 10 participants
`Allocation: Randomized
`Intervention Model: Parallel Assignment
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0002
`
`

`

`Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`Masking: None (Open Label)
`Primary Purpose: Health Services Research
`Official Title: Prevention of Hypoglycemia in Patients With Post-Gastric Bypass
`Hyperinsulinemic Hypoglycemia
`Study Start Date  : August 2013
`Actual Primary Completion Date  : August 2014
`Actual Study Completion Date  : August 2014
`
`- - - - ,
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics: Congenital hyperinsulinism
`
`MedlinePlus related topics: Hypoglycemia
`
`Genetic and Rare Diseases Information Center resources:
`Congenital Hyperinsulinism
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm 
`
`Intervention/treatment 
`
`a high carbohydrate test meal (control condition)
`a high carbohydrate test meal (control condition)
`
`Active Comparator: high carbohydrate test meal after
`pre-treatment
`a high carbohydrate test meal after pre-treatment
`with rapid acting aspart insulin (insulin condition)
`
`Active Comparator: high fructose low glucose test meal
`high fructose , low glucose test meal with
`carbohydrate and caloric content similar to the
`control meal (fructose condition)
`
`Other: high carbohydrate test meal
`Other: high carbohydrate test meal after pre-treatment
`with rapid acting aspart insulin
`Other: high fructose , low glucose test meal with
`carbohydrate and caloric content similar to the control
`meal
`
`Other: high carbohydrate test meal
`Other: high carbohydrate test meal after pre-treatment
`with rapid acting aspart insulin
`Other: high fructose , low glucose test meal with
`carbohydrate and caloric content similar to the control
`meal
`
`Other: high carbohydrate test meal
`Other: high carbohydrate test meal after pre-treatment
`with rapid acting aspart insulin
`Other: high fructose , low glucose test meal with
`carbohydrate and caloric content similar to the control
`meal
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 3
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0003
`
`

`

`Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures  :
`1. The primary study endpoint will be occurrence or not of plasma glucose < 60 mg/dL during the 4 hours after
`the test meal (binary endpoint). [ Time Frame: 4 hours after meal ]
`
`The primary study endpoint will be occurrence or not of plasma glucose < 60 mg/dL during the 4 hours
`after the test meal (binary endpoint).
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your
`doctor and family members or friends about deciding to join a study. To learn more
`about this study, you or your doctor may contact the study research staff using the
`contacts provided below. For general information, Learn About Clinical Studies.
`
`Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
`Sexes Eligible for Study: All
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`•
`•
`
`Participants must be at least 21 years of age
`History of postprandial hypoglycemia with neuroglycopenia occurring one year or more after gastric bypass
`surgery
`History of spontaneous correction of hypoglycemia
`Normal fasting plasma glucose and serum insulin after a carbohydrate containing mixed meal,
`demonstration of serum insulin > 50u/UL and plasma glucose < 50mg/dL
`
`•
`•
`
`Exclusion Criteria:
`•
`
`Under 21 years of age
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0004
`
`

`

`Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`Contacts and Locations
`
`Go to
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research
`staff using the contact information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number):
`NCT01933490
`
`Locations
`
`United States, Minnesota
`University of Minnesota
`Minneapolis, Minnesota, United States, 55455
`
`Sponsors and Collaborators
`University of Minnesota
`
`Investigators
`Principal Investigator:
`
`John Bantle, MD University of Minnesota
`
`More Information
`
`Go to
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Bantle AE, Wang Q, Bantle JP. Post-Gastric Bypass Hyperinsulinemic Hypoglycemia: Fructose is a
`Carbohydrate Which Can Be Safely Consumed. J Clin Endocrinol Metab. 2015 Aug;100(8):3097-102. doi:
`10.1210/jc.2015-1283. Epub 2015 Jun 2.
`
`University of Minnesota
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT01933490 History of Changes
`Other Study ID Numbers:
`1306M37181
`First Posted:
`September 2, 2013 Key Record Dates
`Last Update Posted:
`November 1, 2019
`Last Verified:
`October 2019
`
`Keywords provided by University of Minnesota:
`hyperinsulinemic hypoglycemia
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 5
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0005
`
`

`

`Post-Gastric Bypass Hypoglycemia - Full Text View - ClinicalTrials.gov
`
`Additional relevant MeSH terms:
`Congenital Hyperinsulinism
`Nesidioblastosis
`Hypoglycemia
`Glucose Metabolism Disorders
`Metabolic Diseases
`Pancreatic Diseases
`
`Digestive System Diseases
`Infant, Newborn, Diseases
`Hyperinsulinism
`Insulin Aspart
`Hypoglycemic Agents
`Physiological Effects of Drugs
`
`For Patients and Families
`
`
`
`For Researchers
`
`
`
`For Study Record Managers
`
`HOME
`
` RSS FEEDS
`
` SITE MAP
`
` TERMS AND CONDITIONS
`
` DISCLAIMER
`
` CUSTOMER SUPPORT
`
`TO TOP
`
` HHS Vulnerability Disclosure
` USA.gov
` Freedom of Information Act
` Viewers and Players
` Accessibility
` Privacy
`Copyright
`- - - - - - - - - - - - - - - - - - - - - - - -
` U.S. National Institutes of Health
` U.S. Department of Health and Human Services
`U.S. National Library of Medicine
`
`https://www.clinicaltrials.gov/ct2/show/NCT01933490[3/10/2023 1:50:50 PM]
`
`MPI EXHIBIT 1080 PAGE 6
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1080-0006
`
`