Type 1 DiabetesPhase 3IITNCT01762644
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
A Phase 3 study testing Oral Cyclosporine and Oral Omeprazole and Oral Omeprazole in people with Type 1 Diabetes, run by Perle Bioscience, Inc..
Trial summary
The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Oral Cyclosporine and Oral Omeprazole and Oral Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants included in this study are those who meet all of the following criteria:
- Male or female participant 10-20 years old.
- Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the American Diabetes Association (ADA) criteria.
- History of at least one positive result on testing for any of the following antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies.
- Body weight > 30 kg.
- Signs or symptoms of diabetes within 12 weeks of the first study visit.
Show all 11Show fewer
- Requires insulin > 0.2 units/kg body weight/day for T1DM
- Fasting C-peptide greater than 0.3 ng/mL = 0.1 nmol/L = 100 pmol/L = 0.1 pmol/mL and Glucagon Stimulated C-peptide greater than 0.6 ng/mL = 0.2 nmol/L = 200 pmol/L = 0.2 pmol/mL.
- Female of child bearing potential must have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device] or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to first clinic visit)]. Female of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug.
- Able to swallow capsules.
- Able to read, understand, and provide signed informed consent for the study (participants under the age of 18, shall provide an assent for the study as per country requirements).
Who cannot join
- Participants must not meet any of the following exclusion criteria to be eligible for the study:
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or impact participant safety or evaluability of drug effect.
- Prior administration of immunosuppressants at any time in the past, including in a clinical trial for type 1 diabetes.
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks prior to the first clinic visit.
- Taking any prescription medications, vitamins or herbal supplements that are contraindicated with cyclosporine within the last 14 days prior to first clinic visit.
- Pregnant or lactating female.
Show all 20Show fewer
- Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion.
- Current treatment with oral antidiabetic agents.
- Evidence of active or latent tuberculosis.
- Vaccination with a live virus or organism within the last 8 weeks prior to the first clinic visit.
- Influenza vaccination with a killed virus, including booster vaccinations, within the last 4 weeks prior to the first clinic visit.
- Vaccination with other antigens or killed organisms within the last 8 weeks prior to the first clinic visit.
- Any infectious mononucleosis-like illness within the last 6 months prior to the first clinic visit.
- History of or known active infection with HIV, HCV, or HBV.
- Systolic or diastolic blood pressure >150 mmHg and > 90 mmHg, respectively, at the first clinic visit.
- 95% percentile for weight at the first clinic visit.
- An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN) at the first clinic visit.
- A blood urea nitrogen (BUN) > 50 mg/dL (> 17.85 mmol/L) or a serum creatinine level > 1.3 mg/dL (> 115 µmol/L) at the first clinic visit.
- A serum amylase level > 1.5 times the ULN or a serum lipase level > 2 times the ULN at the first clinic visit.
- A history of substance abuse or dependence within the last 12 months prior to the first clinic visit as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria.
About this study
Official title: A Phase IIB/III Multicenter Randomized Trial to Evaluate the Combination of Low-Dose Cyclosporine and Omeprazole Versus Omeprazole Alone in Participants With New Onset Type 1 Diabetes.
The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. This two-arm study is designed to evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved therapies among recent onset type 1 diabetes patients.
One of the greatest new insights of today in the field of type 1 diabetes, is the understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan 2103).
Read more
More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the potential to increase beta cell mass by 40%, but among type 1 patients without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014).
The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes.
More than 60 human trials have been conducted among type 1 diabetes with a variety of different therapies aimed at preventing autoimmune attack on insulin-producing beta cells. None have been as effective as cyclosporine in both slowing the decline in beta cell mass and resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010).
Because cyclosporine is known for its potential side-effects, most notably in the kidney, all previous studies among type 1 patients have carefully monitored kidney function. Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did not demonstrate renal or other side effects at the dosages that will be used in this trial (Assan 2002).
The most effective initiating dosage for insulin independence in the cyclosporine trials was 7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and will monitor kidney function and cyclosporine levels initially on a weekly basis. This study will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney or resulted in non-reversible side effects among more than 500 patients with recent onset type 1 diabetes treated with cyclosporine.
Omeprazole has been shown to significantly increase gastrin levels which is associated with increased beta cells. Lansoprazole has also been shown to be safe among patients with new onset type 1 diabetes for one year with a trend toward increased beta cell mass among patients with higher gastrin levels.
In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those randomized to receive a proton pump inhibitor had significantly increased gastrin levels, higher insulin levels and improved endocrine function by glucose tolerance testing and less pancreatic atrophy as measured by CT scans (Jang 2003).
The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells was specifically noted to have likely been due to lack of usage of immune therapy to protect beta cells (Griffin 2014, Rigby 2014).
Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the control group had a trend towards improved preservation of C-peptide with a suggestion of a decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental data). Glucose levels also trended lower than controls in the intervention arm with gastrin levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006). REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy among type 1 patients (Griffin 2014, Rigby 2014).
The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate maintenance and expansion of residual beta cells. This combination therapy provides the unique ability for patients to become insulin independent.
For a request of references, please email info@perlebioscience.com
- Conditions
- Type 1 Diabetes
- Being tested
- Oral Cyclosporine and Oral Omeprazole, Oral Omeprazole
- Keywords
- Type 1 Diabetes, Insulin Independence, Beta Regeneration, Immune Tolerance Agent, Omeprazole, Cyclosporine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cyclosporine and Oral OmeprazoleDrug
Oral OmeprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Immune Tolerance and Proton Pump Inhibitor Receives: Drug: Oral Cyclosporine and Oral Omeprazole |
| Arm 2 | Active comparator | Proton Pump Inhibitor Receives: Drug: Oral Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Independence and Hemoglobin A1c (A1C) < 6.5%
Measured: 24 weeks
Secondary outcomes (5)
Safety and tolerability
Measured: 24 weeks
Pancreatic beta cell function measured by glucagon stimulated C-peptide response
Measured: 24 weeks
Proportion of participants achieving insulin independence
Measured: 24 weeks
Blood glucose control measured by A1C
Measured: 24 weeks
Average daily insulin requirement per week
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startAug 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: This study was withdrawn prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perle Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Responsible party
- Sponsor
- Investigators
- Professor Paolo Pozzilli, MD, Principal investigator, Head, Endocrinology and Diabetes Unit, Campus Bio-Medico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762644
- Sponsor's protocol ID
- PRL001-PB-01
- Other IDs
- 2015-000105-39, 2015
- Acronym
- IIT
- Status last verified
- Jul 2015
- First submitted
- 2 Jan 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Assan R, Blanchet F, Feutren G, Timsit J, Larger E, Boitard C, Amiel C, Bach JF. Normal renal function 8 to 13 years after cyclosporin A therapy in 285 diabetic patients. Diabetes Metab Res Rev. 2002 Nov-Dec;18(6):464-72. doi: 10.1002/dmrr.325.
PubMed 12469360Bougneres PF, Carel JC, Castano L, Boitard C, Gardin JP, Landais P, Hors J, Mihatsch MJ, Paillard M, Chaussain JL, et al. Factors associated with early remission of type I diabetes in children treated with cyclosporine. N Engl J Med. 1988 Mar 17;318(11):663-70. doi: 10.1056/NEJM198803173181103.
PubMed 3125434Eisenbarth GS Immunotherapy of diabetes and selected autoimmune diseases, CRC Press, Inc. 1989:61-72.
Feutren G, Papoz L, Assan R, Vialettes B, Karsenty G, Vexiau P, Du Rostu H, Rodier M, Sirmai J, Lallemand A, et al. Cyclosporin increases the rate and length of remissions in insulin-dependent diabetes of recent onset. Results of a multicentre double-blind trial. Lancet. 1986 Jul 19;2(8499):119-24. doi: 10.1016/s0140-6736(86)91943-4.
PubMed 2873396Griffin KJ, Thompson PA, Gottschalk M, Kyllo JH, Rabinovitch A. Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):710-8. doi: 10.1016/S2213-8587(14)70115-9. Epub 2014 Jul 2.
PubMed 24997559Jang JY, Kim SW, Han JK, Park SJ, Park YC, Joon Ahn Y, Park YH. Randomized prospective trial of the effect of induced hypergastrinemia on the prevention of pancreatic atrophy after pancreatoduodenectomy in humans. Ann Surg. 2003 Apr;237(4):522-9. doi: 10.1097/01.SLA.0000059985.56982.11.
PubMed 12677149Levetan C, Pozzilli P, Jovanovic L, Schatz D. Proposal for generating new beta cells in a muted immune environment for type 1 diabetes. Diabetes Metab Res Rev. 2013 Nov;29(8):604-6. doi: 10.1002/dmrr.2435.
PubMed 23853103Meier JJ, Ritzel RA, Maedler K, Gurlo T, Butler PC. Increased vulnerability of newly forming beta cells to cytokine-induced cell death. Diabetologia. 2006 Jan;49(1):83-9. doi: 10.1007/s00125-005-0069-3. Epub 2005 Dec 2.
PubMed 16323002Rigby MR. Non-immune-based treatment for type 1 diabetes: the way to go? Lancet Diabetes Endocrinol. 2014 Sep;2(9):681-2. doi: 10.1016/S2213-8587(14)70139-1. Epub 2014 Jul 2. No abstract available.
PubMed 24997558Singh PK, Hota D, Dutta P, Sachdeva N, Chakrabarti A, Srinivasan A, Singh I, Bhansali A. Pantoprazole improves glycemic control in type 2 diabetes: a randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2012 Nov;97(11):E2105-8. doi: 10.1210/jc.2012-1720. Epub 2012 Aug 17.
PubMed 22904177Skyler JS, Rabinovitch A. Cyclosporine in recent onset type I diabetes mellitus. Effects on islet beta cell function. Miami Cyclosporine Diabetes Study Group. J Diabetes Complications. 1992 Apr-Jun;6(2):77-88. doi: 10.1016/1056-8727(92)90016-e.
PubMed 1611143Sobel DO, Henzke A, Abbassi V. Cyclosporin and methotrexate therapy induces remission in type 1 diabetes mellitus. Acta Diabetol. 2010 Sep;47(3):243-50. doi: 10.1007/s00592-010-0188-2. Epub 2010 May 4.
PubMed 20440520Cyclosporin-induced remission of IDDM after early intervention. Association of 1 yr of cyclosporin treatment with enhanced insulin secretion. The Canadian-European Randomized Control Trial Group. Diabetes. 1988 Nov;37(11):1574-82.
PubMed 2903105
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB/III Multicenter Randomized Trial to Evaluate the Combination of Low-Dose Cyclosporine and Omeprazole Versus Omeprazole Alone in Participants With New Onset Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT01762644
- Acronym / sponsor ID
- IIT / PRL001-PB-01
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Insulin Independence, Beta Regeneration, Immune Tolerance Agent, Omeprazole, Cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Perle Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Study start
- Aug 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. This two-arm study is designed to evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved therapies among recent onset type 1 diabetes patients.
One of the greatest new insights of today in the field of type 1 diabetes, is the understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan 2103).
More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the potential to increase beta cell mass by 40%, but among type 1 patients without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014).
The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes.
More than 60 human trials have been conducted among type 1 diabetes with a variety of different therapies aimed at preventing autoimmune attack on insulin-producing beta cells. None have been as effective as cyclosporine in both slowing the decline in beta cell mass and resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010).
Because cyclosporine is known for its potential side-effects, most notably in the kidney, all previous studies among type 1 patients have carefully monitored kidney function. Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did not demonstrate renal or other side effects at the dosages that will be used in this trial (Assan 2002).
The most effective initiating dosage for insulin independence in the cyclosporine trials was 7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and will monitor kidney function and cyclosporine levels initially on a weekly basis. This study will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney or resulted in non-reversible side effects among more than 500 patients with recent onset type 1 diabetes treated with cyclosporine.
Omeprazole has been shown to significantly increase gastrin levels which is associated with increased beta cells. Lansoprazole has also been shown to be safe among patients with new onset type 1 diabetes for one year with a trend toward increased beta cell mass among patients with higher gastrin levels.
In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those randomized to receive a proton pump inhibitor had significantly increased gastrin levels, higher insulin levels and improved endocrine function by glucose tolerance testing and less pancreatic atrophy as measured by CT scans (Jang 2003).
The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells was specifically noted to have likely been due to lack of usage of immune therapy to protect beta cells (Griffin 2014, Rigby 2014).
Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the control group had a trend towards improved preservation of C-peptide with a suggestion of a decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental data). Glucose levels also trended lower than controls in the intervention arm with gastrin levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006). REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy among type 1 patients (Griffin 2014, Rigby 2014).
The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate maintenance and expansion of residual beta cells. This combination therapy provides the unique ability for patients to become insulin independent.
For a request of references, please email info@perlebioscience.com
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Oral Cyclosporine and Oral OmeprazoleImmune Tolerance and Proton Pump Inhibitor |
| Arm 2 | Active comparator | Drug: Oral OmeprazoleProton Pump Inhibitor |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Male or female participant 10-20 years old.
- Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the American Diabetes Association (ADA) criteria.
- History of at least one positive result on testing for any of the following antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies.
- Body weight > 30 kg.
- Signs or symptoms of diabetes within 12 weeks of the first study visit.
Key exclusion criteria (20 listed)
- Participants must not meet any of the following exclusion criteria to be eligible for the study:
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or impact participant safety or evaluability of drug effect.
- Prior administration of immunosuppressants at any time in the past, including in a clinical trial for type 1 diabetes.
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks prior to the first clinic visit.
- Taking any prescription medications, vitamins or herbal supplements that are contraindicated with cyclosporine within the last 14 days prior to first clinic visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Cyclosporine and Oral Omeprazole | Drug | Arm 1 |
| Oral Omeprazole | Drug | Arm 2 |
Primary outcome
Insulin Independence and Hemoglobin A1c (A1C) < 6.5%
Time frame: 24 weeks
5 secondary outcomes
Safety and tolerability
Time frame: 24 weeks
Pancreatic beta cell function measured by glucagon stimulated C-peptide response
Time frame: 24 weeks
Proportion of participants achieving insulin independence
Time frame: 24 weeks
Blood glucose control measured by A1C
Time frame: 24 weeks
Average daily insulin requirement per week
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Background: PubMed 12469360Assan R, Blanchet F, Feutren G, Timsit J, Larger E, Boitard C, Amiel C, Bach JF. Normal renal function 8 to 13 years after cyclosporin A therapy in 285 diabetic patients. Diabetes Metab Res Rev. 2002 Nov-Dec;18(6):464-72. doi: 10.1002/dmrr.325.
- Background: PubMed 3125434Bougneres PF, Carel JC, Castano L, Boitard C, Gardin JP, Landais P, Hors J, Mihatsch MJ, Paillard M, Chaussain JL, et al. Factors associated with early remission of type I diabetes in children treated with cyclosporine. N Engl J Med. 1988 Mar 17;318(11):663-70. doi: 10.1056/NEJM198803173181103.
- BackgroundEisenbarth GS Immunotherapy of diabetes and selected autoimmune diseases, CRC Press, Inc. 1989:61-72.
- Background: PubMed 2873396Feutren G, Papoz L, Assan R, Vialettes B, Karsenty G, Vexiau P, Du Rostu H, Rodier M, Sirmai J, Lallemand A, et al. Cyclosporin increases the rate and length of remissions in insulin-dependent diabetes of recent onset. Results of a multicentre double-blind trial. Lancet. 1986 Jul 19;2(8499):119-24. doi: 10.1016/s0140-6736(86)91943-4.
- Background: PubMed 24997559Griffin KJ, Thompson PA, Gottschalk M, Kyllo JH, Rabinovitch A. Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):710-8. doi: 10.1016/S2213-8587(14)70115-9. Epub 2014 Jul 2.
- Background: PubMed 12677149Jang JY, Kim SW, Han JK, Park SJ, Park YC, Joon Ahn Y, Park YH. Randomized prospective trial of the effect of induced hypergastrinemia on the prevention of pancreatic atrophy after pancreatoduodenectomy in humans. Ann Surg. 2003 Apr;237(4):522-9. doi: 10.1097/01.SLA.0000059985.56982.11.
- Background: PubMed 23853103Levetan C, Pozzilli P, Jovanovic L, Schatz D. Proposal for generating new beta cells in a muted immune environment for type 1 diabetes. Diabetes Metab Res Rev. 2013 Nov;29(8):604-6. doi: 10.1002/dmrr.2435.
- Background: PubMed 16323002Meier JJ, Ritzel RA, Maedler K, Gurlo T, Butler PC. Increased vulnerability of newly forming beta cells to cytokine-induced cell death. Diabetologia. 2006 Jan;49(1):83-9. doi: 10.1007/s00125-005-0069-3. Epub 2005 Dec 2.
- Background: PubMed 24997558Rigby MR. Non-immune-based treatment for type 1 diabetes: the way to go? Lancet Diabetes Endocrinol. 2014 Sep;2(9):681-2. doi: 10.1016/S2213-8587(14)70139-1. Epub 2014 Jul 2. No abstract available.
- Background: PubMed 22904177Singh PK, Hota D, Dutta P, Sachdeva N, Chakrabarti A, Srinivasan A, Singh I, Bhansali A. Pantoprazole improves glycemic control in type 2 diabetes: a randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2012 Nov;97(11):E2105-8. doi: 10.1210/jc.2012-1720. Epub 2012 Aug 17.
- Background: PubMed 1611143Skyler JS, Rabinovitch A. Cyclosporine in recent onset type I diabetes mellitus. Effects on islet beta cell function. Miami Cyclosporine Diabetes Study Group. J Diabetes Complications. 1992 Apr-Jun;6(2):77-88. doi: 10.1016/1056-8727(92)90016-e.
- Background: PubMed 20440520Sobel DO, Henzke A, Abbassi V. Cyclosporin and methotrexate therapy induces remission in type 1 diabetes mellitus. Acta Diabetol. 2010 Sep;47(3):243-50. doi: 10.1007/s00592-010-0188-2. Epub 2010 May 4.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Paolo Pozzilli, MD principal investigator
Head, Endocrinology and Diabetes Unit, Campus Bio-Medico University of Rome
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Cyclosporine and Oral Omeprazole and Oral Omeprazole in people with Type 1 Diabetes, run by Perle Bioscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Independence and Hemoglobin A1c (A1C) < 6.5% (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762644, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.