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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR TOLBUTAMIDE

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Clinical Trials for Tolbutamide

Trial ID Title Status Sponsor Phase Summary
NCT00082238 Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A People with CF have a high incidence of diabetes, called CFRD. CFRD is an important cause of worsened morbidity and mortality, thus understanding the pathophysiology underlying its development is imperative. Insulin deficiency has been well recognized as one cause of CFRD; however the clinical presentation and studies of pathogenesis indicate that the etiology is more complex. There is strong evidence that normal metabolism of carbohydrate, protein and fat is altered in CF. We believe that the inflammatory response to chronic underlying lung disease is responsible for insulin resistance and alters substrate metabolism, and that these changes, in addition to insulin deficiency cause CFRD. Our global hypothesis is that hyperglycemia is caused, in part, by high rates of gluconeogenesis resulting from excessive amino acid substrate availability caused by cytokine-mediated protein catabolism. We further hypothesize that inflammation alters normal fatty acid metabolism leading to lipogenesis, an energy wasteful pathway. We will recruit 24 adult CF subjects and 10 controls (similar in distribution in lean tissue mass, age and gender) and will categorize them according to glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the Tolbutamide-stimulated IVGTT and the Minimal Model. Clinical status will be characterized by measuring pulmonary function and modified NIH scores, in addition to measuring levels of circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Amino acid turnover rates will be measured using stable isotopes of lactate and alanine and whole body protein turnover (WBPT) will be measured using [1-13C]leucine and [15N2]urea. Fat metabolism will be evaluated by measuring ketone body turnover using stable isotopes, and by quantifying lipogenesis using the isotopomer equilibration method. Key enzymes of fatty acid metabolism will also be measured. We will utilize indirect calorimetry to measure resting energy expenditure. Subjects will be recruited from the CF centers at the University of Texas- Southwestern and the South Central CF Consortium. Our proposal is intended to better describe the unique metabolism of people with CF, and to provide a comprehensive evaluation of pathophysiologic changes which contribute to the development of CFRD and to wasting; and are part of the applicant's long-range goal which is to identify the underlying causes of CF related diabetes and catabolism so that disease-specific therapies can be developed. We fully expect that the proposed studies will provide new and important information.
NCT00369304 Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.
NCT00668395 Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics Completed Indiana University N/A 1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medications ineffective. 2. To see how efavirenz interact with other drugs taken at the same time with it. 3. To see if genetic differences can change the way how the liver breaks down efavirenz and its interactions with other co-administered drugs.
NCT00676910 A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors. Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these patients.
NCT00732966 Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics? Unknown status Assaf-Harofeh Medical Center N/A Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9), one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic importance in choosing the right ARB for the right patient.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tolbutamide

Condition Name

Condition Name for Tolbutamide
Intervention Trials
Healthy 5
Diabetes Mellitus, Type 2 3
Hereditary Angioedema 1
Type 2 Diabetes 1
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Condition MeSH

Condition MeSH for Tolbutamide
Intervention Trials
Diabetes Mellitus, Type 2 5
Diabetes Mellitus 5
Lymphoma 1
Hepatitis C, Chronic 1
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Clinical Trial Locations for Tolbutamide

Trials by Country

Trials by Country for Tolbutamide
Location Trials
United States 9
United Kingdom 7
Canada 7
Germany 2
Belgium 1
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Trials by US State

Trials by US State for Tolbutamide
Location Trials
Arizona 1
Utah 1
Pennsylvania 1
New Jersey 1
Maryland 1
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Clinical Trial Progress for Tolbutamide

Clinical Trial Phase

Clinical Trial Phase for Tolbutamide
Clinical Trial Phase Trials
Phase 4 3
Phase 1 14
N/A 6
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Clinical Trial Status

Clinical Trial Status for Tolbutamide
Clinical Trial Phase Trials
Completed 14
Enrolling by invitation 2
Recruiting 2
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Clinical Trial Sponsors for Tolbutamide

Sponsor Name

Sponsor Name for Tolbutamide
Sponsor Trials
Canadian Institutes of Health Research (CIHR) 4
Canadian Network for Observational Drug Effect Studies, CNODES 3
Drug Safety and Effectiveness Network, Canada 3
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Sponsor Type

Sponsor Type for Tolbutamide
Sponsor Trials
Other 16
Industry 13
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Dow
Johnson and Johnson
Queensland Health
Farmers Insurance
Boehringer Ingelheim
Healthtrust
Harvard Business School
Deloitte

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