Type 1 DiabetesPhase 3IITNCT01762657
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
A Phase 3 study testing Oral Cyclosporine and Oral Lansoprazole in people with Type 1 Diabetes, run by Perle Bioscience, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Oral Cyclosporine and Oral Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2015
- 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 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- They are male or female, 8-60 years of age
- They have a history of onset of type 1 Diabetes Mellitus at or before 20 years of age; or have documentation of autoimmunity testing to the pancreas to include one of more of the following tests
- Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- Glutamic Acid Decarboxylase (GAD) autoantibodies, or
- Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive)
- They have a C-peptide of greater than or equal to to 0.6 ng/mL (0.2 nmol/L)
Show all 9Show fewer
- They have a Hemoglobin A1C levels of less than 9%
- They are able and willing to participate in the study, as evidenced by providing written informed consent
- Females must be post-menopausal (at least 1 year without spontaneous menses) or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or to 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]. Females of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug.
Who cannot join
- Prior administration of immune tolerance therapy or immune tolerance clinical trial for type 1 diabetes
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
- 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
Show all 22Show fewer
- Evidence of active or latent tuberculosis
- Vaccination with a live virus or organism within the 8 weeks before randomization continuing through week 52 of the study
- Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle
- Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
- Systolic or diastolic blood pressure >150 mmHg and 90 mmHg, respectively, as measured by an appropriately sized cuff;
- A body mass index (BMI) >28 kg/m2
- Worsening retinopathy, angina, or congestive heart failure
- A history or presence of acute or chronic pancreatitis
- A history or presence of any illness, disease, or condition that could impact patient safety or evaluability of drug effect, in the Investigator's opinion
- An episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days
- An episode of diabetic ketoacidosis during the prior 6 months
- Received any new hypoglycemic medications within the past 3 months
- An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN)
- A blood urea nitrogen (BUN) level >50 mg/dL or a serum creatinine level >1.4 mg/dL
- A serum amylase level >1.5 times the ULN or a serum lipase level >2 times the ULN
- A history of substance abuse or dependence in the past year as defined by the Diagnostic and Statistical Manual of Mental Disorders, (DSM V) criteria
About this study
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
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. 1955;142(4):709-23).
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 67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988:17;318(11):663-70). 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.
Read more
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. 2002;18(6):464-72). 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 http://www.transitiontherapeutics.com/media/archive.php 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. 2005;90(6):3401-3409).
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. 2007;1103:19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 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 patients.A
This 52-week study consists of two treatment arms designed to assess the safety and efficacy of achieving insulin independence using:
- Oral Lansoprazole/Oral Cyclosporine A
- Oral Placebo/Oral 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Oral Cyclosporine and Oral Lansoprazole, Placebos
- Keywords
- Type 1 Diabetes, Insulin Independence, Beta Regeneration, Immune Tolerance Agent, Lanzoprazole, 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 LansoprazoleDrug
Oral Cyclosporine A dosed at 7.5 mg/kg/day and Oral Lansoprazole dosed at 30 mg in two divided dosages to subjects ages 8-15 and 60 60 mg in divided dosages to subjects ages 16-60. The Cyclosporine A and Lansoprazole may be given as an oral tablet/capsule or oral suspension.
PlacebosDrug
Two oral placebos are given at breakfast and dinner. The placebos may be given as an oral tablets/capsules or oral suspensions.
| Study group | Role | What they receive |
|---|---|---|
| Oral CyclosporineA and Oral Lansoprazole | Experimental | Oral Cyclosporine A dosed at 7.5 mg/kg/day in two divided dosages given with Lansoprazole dosed at 30 mg per day in two divided dosages for subjects aged 8-15 year and 60 mg per day for those aged 16-60. Receives: Drug: Oral Cyclosporine and Oral Lansoprazole |
| Placebos | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Requirements Among Patients Treated with Oral Cyclosporine and Oral Lansoprazole
Measured: 26 and 52 weeks
Secondary outcomes (1)
Glucagon C-peptide (under the curve) and Hemoglobin A1C levels among patients with existing type 1 diabetes treated with Cyclosporine and Lansoprazole
Measured: 26 and 52 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 startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: Study stopped prior to Patient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perle Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claresa Levetan, MD, Principal investigator, Perle Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762657
- Sponsor's protocol ID
- Perle-1102
- Acronym
- IIT
- Status last verified
- Apr 2016
- First submitted
- 2 Jan 2013
- Last updated
- 19 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 3125434Wang TC, Bonner-Weir S, Oates PS, Chulak M, Simon B, Merlino GT, Schmidt EV, Brand SJ. Pancreatic gastrin stimulates islet differentiation of transforming growth factor alpha-induced ductular precursor cells. J Clin Invest. 1993 Sep;92(3):1349-56. doi: 10.1172/JCI116708.
PubMed 8376589
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01762657
- Acronym / sponsor ID
- IIT / Perle-1102
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Insulin Independence, Beta Regeneration, Immune Tolerance Agent, Lanzoprazole, Cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped prior to Patient Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Perle Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (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 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. 1955;142(4):709-23).
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 67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988:17;318(11):663-70). 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. 2002;18(6):464-72). 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 http://www.transitiontherapeutics.com/media/archive.php 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. 2005;90(6):3401-3409).
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. 2007;1103:19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 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 patients.A
This 52-week study consists of two treatment arms designed to assess the safety and efficacy of achieving insulin independence using:
- Oral Lansoprazole/Oral Cyclosporine A
- Oral Placebo/Oral 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral CyclosporineA and Oral Lansoprazole | Experimental | Drug: Oral Cyclosporine and Oral LansoprazoleOral Cyclosporine A dosed at 7.5 mg/kg/day in two divided dosages given with Lansoprazole dosed at 30 mg per day in two divided dosages for subjects aged 8-15 year and 60 mg per day for those aged 16-60. |
| Placebos | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- They are male or female, 8-60 years of age
- They have a history of onset of type 1 Diabetes Mellitus at or before 20 years of age; or have documentation of autoimmunity testing to the pancreas to include one of more of the following tests
- They have a C-peptide of greater than or equal to to 0.6 ng/mL (0.2 nmol/L)
- They have a Hemoglobin A1C levels of less than 9%
- They are able and willing to participate in the study, as evidenced by providing written informed consent
Key exclusion criteria (22 listed)
- Prior administration of immune tolerance therapy or immune tolerance clinical trial for type 1 diabetes
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
- 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
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 LansoprazoleOral Cyclosporine A dosed at 7.5 mg/kg/day and Oral Lansoprazole dosed at 30 mg in two divided dosages to subjects ages 8-15 and 60 60 mg in divided dosages to subjects ages 16-60. The Cyclosporine A and Lansoprazole may be given as an oral tablet/capsule or oral suspension. | Drug | Oral CyclosporineA and Oral Lansoprazole |
| PlacebosTwo oral placebos are given at breakfast and dinner. The placebos may be given as an oral tablets/capsules or oral suspensions. | Drug | Placebos |
Primary outcome
Insulin Requirements Among Patients Treated with Oral Cyclosporine and Oral Lansoprazole
Time frame: 26 and 52 weeks
1 secondary outcome
Glucagon C-peptide (under the curve) and Hemoglobin A1C levels among patients with existing type 1 diabetes treated with Cyclosporine and Lansoprazole
Time frame: 26 and 52 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 19 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.
- Background: PubMed 8376589Wang TC, Bonner-Weir S, Oates PS, Chulak M, Simon B, Merlino GT, Schmidt EV, Brand SJ. Pancreatic gastrin stimulates islet differentiation of transforming growth factor alpha-induced ductular precursor cells. J Clin Invest. 1993 Sep;92(3):1349-56. doi: 10.1172/JCI116708.
- MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1Link 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.
Claresa Levetan, MD principal investigator
Perle Bioscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Cyclosporine and Oral Lansoprazole 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 9 inclusion and 22 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 19 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. Some participants in this study may receive a placebo. 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 Requirements Among Patients Treated with Oral Cyclosporine and Oral Lansoprazole (time frame: 26 and 52 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 NCT01762657, which also lists 3 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 19 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.