Ignite Creation Date:
2024-05-06 @ 1:15 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01762657
Status:
WITHDRAWN
Last Update Posted:
2016-04-19
First Post:
2013-01-02
Brief Title:
The Insulin Independence Trial IIT Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes
Sponsor:
Perle Bioscience Inc
Organization:
Perle Bioscience Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate the Safety and Efficacy in Diminishing Insulin Requirements Utilizing Oral Cyclosporine With Oral Lansoprazole in Children and Adults With Existing Type 1 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped prior to Patient Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IIT
Brief Summary:
The purpose of this study is to determine if oral Cyclosporine A and oral Lansoprazole are effective in rendering patients with existing type 1 diabetes insulin independent This two-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent Cyclosporine A and the FDA-approved proton-pump inhibitor Lansoprazole Lansoprazole and other proton-pump inhibitors increase gastrin levels Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 Zollinger RM and Ellison EH Ann Surg 19551424709-23
Studies with the immune tolerance agent Cyclosporine A previously demonstrated that among recently diagnosed type 1 diabetes patients insulin independence was achieved in as many as 675 of patients within 7 weeks of therapy Bougneres PF et al N Engl J Med 19881731811663-70 Cyclosporine A protected the remaining beta cells from further autoimmune attack but over time there was limited beta cell regeneration and insulin was ultimately required by all patients Therefore this study proposes the usage of Cyclosporine A with a beta regeneration agent
Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for 20 months did not demonstrate renal or other side effects Assan R et al Diabetes Metab Res Rev 2002186464-72 Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75 within 3 months following four weeks of therapy among existing type 1 diabetes patients Transition Therapeutics March 5 2007 httpwwwtransitiontherapeuticscommediaarchivephp Accessed January 1 2013 Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in vitro studies Suarez-Pinzon WL et al JCEM 20059063401-3409
Type 1 diabetes is an autoimmune disease Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models none have been successful in sustaining insulin independence in man Ablamunits V et al Ann NY Acad Sci 2007110319-32 The distinctions and complexities of islets in man are far different than that of rodents Levetan CS and Pierce SM Endocr Pract 2012 Nov 271-36 Epub ahead of print We hypothesize that in man both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold this clinical trial utilizes the oral proton-pump inhibitor Lansoprazole This study will determine the safety and efficacy of Cyclosporine A used with and without Lansoprazole to determine the impact on insulin independence among patients with existing type 1 diabetes
Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with Cyclosporine A or gastrin alone among type 1 patientsA
This 52-week study consists of two treatment arms designed to assess the safety and efficacy of achieving insulin independence using
Oral LansoprazoleOral Cyclosporine A
Oral PlaceboOral Placebo
It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will safely render significantly more patients with existing type 1 diabetes insulin independent and may serve as a novel and innovative treatment approach for patients with type 1 diabetes utilizing two FDA-approved therapies
Studies with the immune tolerance agent Cyclosporine A previously demonstrated that among recently diagnosed type 1 diabetes patients insulin independence was achieved in as many as 675 of patients within 7 weeks of therapy Bougneres PF et al N Engl J Med 19881731811663-70 Cyclosporine A protected the remaining beta cells from further autoimmune attack but over time there was limited beta cell regeneration and insulin was ultimately required by all patients Therefore this study proposes the usage of Cyclosporine A with a beta regeneration agent
Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for 20 months did not demonstrate renal or other side effects Assan R et al Diabetes Metab Res Rev 2002186464-72 Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75 within 3 months following four weeks of therapy among existing type 1 diabetes patients Transition Therapeutics March 5 2007 httpwwwtransitiontherapeuticscommediaarchivephp Accessed January 1 2013 Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in vitro studies Suarez-Pinzon WL et al JCEM 20059063401-3409
Type 1 diabetes is an autoimmune disease Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models none have been successful in sustaining insulin independence in man Ablamunits V et al Ann NY Acad Sci 2007110319-32 The distinctions and complexities of islets in man are far different than that of rodents Levetan CS and Pierce SM Endocr Pract 2012 Nov 271-36 Epub ahead of print We hypothesize that in man both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold this clinical trial utilizes the oral proton-pump inhibitor Lansoprazole This study will determine the safety and efficacy of Cyclosporine A used with and without Lansoprazole to determine the impact on insulin independence among patients with existing type 1 diabetes
Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with Cyclosporine A or gastrin alone among type 1 patientsA
This 52-week study consists of two treatment arms designed to assess the safety and efficacy of achieving insulin independence using
Oral LansoprazoleOral Cyclosporine A
Oral PlaceboOral Placebo
It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will safely render significantly more patients with existing type 1 diabetes insulin independent and may serve as a novel and innovative treatment approach for patients with type 1 diabetes utilizing two FDA-approved therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None