Metabolic Effects of Alcohol - Full Text View - ClinicalTrials.gov
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`Metabolic Effects of Alcohol
`
`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:
`Bantle, John P., MD
`
`Information provided by (Responsible Party):
`University of Minnesota ( Bantle, John P., MD )
`
`ClinicalTrials.gov Identifier: NCT00167115
`
`Recruitment Status  : Completed
`First Posted  : September 14, 2005
`Last Update Posted  : July 10, 2012
`
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`Beta.ClinicalTrials.gov
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`Study Description
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`Brief Summary:
`The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening meal will lower plasma
`glucose during the night and result in lower fasting plasma glucose the next morning; 2) the chronic use of alcohol in
`moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects.
`
`https://www.clinicaltrials.gov/ct2/show/NCT00167115[3/10/2023 1:52:22 PM]
`
`MPI EXHIBIT 1079 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1079-0001
`
`

`

`Metabolic Effects of Alcohol - Full Text View - ClinicalTrials.gov
`
`Condition or disease 
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`Intervention/treatment 
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`Phase 
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`Type 2 Diabetes Mellitus
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`Drug: Alcohol
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`Not Applicable
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`Detailed Description:
`
`The use of alcohol in moderation has been associated with reduced mortality rates, reduced risk of
`cardiovascular disease and reduced risk for type 2 diabetes. However, the effects of alcohol in persons with
`type 2 diabetes have not yet been defined. Moreover, the possibility of alcohol induced hypoglycemia remains a
`safety concern. Finally, little is known about the effects of alcohol on plasma lipids in people with diabetes. To
`address these issues, two substudies are proposed. The first substudy will examine the acute effects of alcohol
`in the form of wine at supper on postprandial and nocturnal glucose levels. The second substudy will examine
`the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids.
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`To test these hypotheses, 20 type 2 diabetics will be studied. In substudy 1, subjects will be admitted to the
`Clinical Research Center for a two day inpatient stay. Blood samples for plasma glucose and serum insulin will
`be obtained every two hours from 5:00 pm to 7:00 am. On one day, subjects will recieve 8 ounces of wine with
`dinner. On the other day, subjects will recieve 8 ounces of fruit juice with dinner. The primary endpoint of
`substudy 1 will be fasting plasma glucose. In substudy 2, subjects will be asked to consume 4-8 ounces of wine
`in the evening for one month and to abstain from wine and alcohol containing beverages for one month. Fasting
`blood samples will be obtained after the month of wine consumption and after the month of abstention from
`alcohol for measurement of fasting lipids. The primary endpoint of substudy 2 will be fasting HDL cholesterol.
`
`Study Design
`
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`Interventional (Clinical Trial)
`Study Type  :
`Enrollment  : 20 participants
`Allocation: Randomized
`Intervention Model: Crossover Assignment
`Masking: None (Open Label)
`Primary Purpose: Treatment
`Official Title: Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2
`Diabetes Mellitus
`Study Start Date  : December 2004
`Actual Primary Completion Date  : September 2005
`Actual Study Completion Date  : September 2005
`
`Resource links provided by the National Library of Medicine
`
`llll}NLM
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`MedlinePlus Genetics related topics: Type 2 diabetes
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`Drug Information available for: Ethanol
`
`https://www.clinicaltrials.gov/ct2/show/NCT00167115[3/10/2023 1:52:22 PM]
`
`MPI EXHIBIT 1079 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1079-0002
`
`

`

`Metabolic Effects of Alcohol - Full Text View - ClinicalTrials.gov
`
`U.S. FDA Resources
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`Outcome Measures
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`Primary Outcome Measures  :
`1. Fasing plasma glucose
`2. Fasting plasma HDL cholesterol
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`Secondary Outcome Measures  :
`1. Episodes of hypoglycemia
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`Eligibility Criteria
`
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`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: 40 Years and older (Adult, Older Adult)
`Sexes Eligible for Study: All
`Accepts Healthy Volunteers: No
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`Criteria
`Inclusion Criteria:
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`Type 2 diabetes HbA1c 6.0-8.0% age > 40 years
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`Exclusion Criteria:
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`History of alcoholism or alcohol abuse liver disease blood pressure > 150/90
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`Contacts and Locations
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`
`https://www.clinicaltrials.gov/ct2/show/NCT00167115[3/10/2023 1:52:22 PM]
`
`MPI EXHIBIT 1079 PAGE 3
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1079-0003
`
`

`

`Metabolic Effects of Alcohol - Full Text View - ClinicalTrials.gov
`
`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):
`NCT00167115
`
`Locations
`
`United States, Minnesota
`University of Minnesota
`Minneapolis, Minnesota, United States, 55455
`
`Sponsors and Collaborators
`Bantle, John P., MD
`
`Investigators
`Principal Investigator:
`
`John Bantle, MD University of Minnesota
`
`More Information
`
`Go to
`
`Bantle, John P., MD
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT00167115 History of Changes
`Other Study ID Numbers:
`0406M61001
`Bantle1
`September 14, 2005 Key Record Dates
`July 10, 2012
`July 2012
`
`First Posted:
`Last Update Posted:
`Last Verified:
`
`Keywords provided by University of Minnesota ( Bantle, John P., MD ):
`Alcohol
`Type 2 diabetes mellitus
`Plama glucose
`HDL cholesterol
`
`Additional relevant MeSH terms:
`Diabetes Mellitus
`
`https://www.clinicaltrials.gov/ct2/show/NCT00167115[3/10/2023 1:52:22 PM]
`
`MPI EXHIBIT 1079 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1079-0004
`
`

`

`Metabolic Effects of Alcohol - Full Text View - ClinicalTrials.gov
`
`Diabetes Mellitus, Type 2
`Glucose Metabolism Disorders
`Metabolic Diseases
`Endocrine System Diseases
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`https://www.clinicaltrials.gov/ct2/show/NCT00167115[3/10/2023 1:52:22 PM]
`
`MPI EXHIBIT 1079 PAGE 5
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1079-0005
`
`