Type 1 Diabetes Clinical Trial
Official title:
A Phase I/IIa Open-label Investigation of the Safety and Effectiveness of DIABECELL(R) [Immunoprotected (Alginate-Encapsulated) Porcine Islets for Xenotransplantation] in Patients With Type I Diabetes Mellitus
Verified date | October 2017 |
Source | Diatranz Otsuka Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to establish the safety of xenotransplantation of DIABECELL(R)[immunoprotected (alginate-encapsulated) porcine islets] in patients with established type 1 diabetes mellitus, and to establish preliminary evidence of the efficacy of DIABECELL(R), as measured by a reduction in serial hemoglobin A1c (HbA1C) levels.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
Inclusion criteria: - Adults (males or females) in the age range 35 to 65 years - Diagnosis of type 1 diabetes mellitus (minimum duration of 5 years) in accordance with the American Diabetes Association's criteria. Patients should have been treated continuously with insulin since diagnosis (Expert Committee on the Diagnosis and Classification of Diabetes Mellitus 2002) - Patients with established brittle type I diabetes mellitus with a well-documented chronic history of severe metabolic instability who cannot achieve acceptable metabolic control without experiencing multiple episodes of severe hypoglycaemia, often with unawareness; or - with degrees of hypoglycaemia, who cannot be adequately managed with intensive insulin therapy alone despite intensive diabetes management delivered by a qualified diabetes team for at least six months prior to enrolment - Patients should have an HbA1C =7% and =10% calculated as the average of the last four consecutive HbA1C readings during the 8-week baseline run-in period. The difference between the highest and lowest of the four HbA1C reading should be no more than 0.5%. - Plasma C-peptide <0.2 ng/ml following a glucagon stimulation test (Scheen et al. 1996) - If female, no childbearing capability (those who are more than 2 years postmenopausal or have undergone voluntary sterilisation can be considered for enrolment) - Provision of written informed consent. Patients will be required to agree to comply with all tests and visits specified in the protocol, and they (and their partners/close contacts) will also be required to consent to long-term microbiological monitoring, which is an integral part of the study Exclusion criteria: - Type 2 diabetes, defined as age of onset >30 years and/or a history of treatment with oral hypoglycaemic medications and/or insulin resistance (defined as an insulin dose requirement =1.2 U/kg/day) - An average HbA1C < 7% and >10% during the 8-week baseline run-in period - Body mass index (BMI) =30 kg/m2 or =20 kg/m2 - Active infection, with plasma C-reactive protein =10 mg/L at baseline - Previous receipt of an organ, skin graft, or other tissue transplant from a human or animal donor - Treatment with immunosuppressive medications for another medical condition - Previous history of peritoneal disease or abnormal findings at baseline laparoscopy - Previous abdominal surgery, excluding uncomplicated appendectomy or cholecystectomy - History of pelvic inflammatory disease or endometriosis - Inability to tolerate oral medications or a history of significant malabsorption - HIV antibody and/or risk factors for HIV infection - Positive hepatitis C antibody, positive hepatitis B surface antigen, and hepatitis B core antibody - Kidney disease, defined as serum creatinine >130 µmol/L in men and >110 µmol/L in women and/or urinary albumin >300 mg/L and/or haematuria and/or active urinary sediment or casts - Diabetes microvascular complications defined as untreated, potentially vision-threatening proliferative or pre-proliferative retinopathy or maculopathy; painful peripheral neuropathy; autonomic neuropathy manifesting as postural hypotension; gastroparesis or diabetic enteropathy - Diagnosis of coeliac disease and history of gastrointestinal symptoms including chronic or recurrent diarrhoea, malabsorption, weight loss, and abdominal distension or bloating on exposure to gluten products in the diet - Serious comorbid conditions that are likely to affect participation in the study, including: 1. Previous coronary heart disease manifesting as non-ST elevation myocardial infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass graft (CABG); or percutaneous angioplasty 2. Previous cerebrovascular disease manifesting as transient ischaemic attacks (TIAs) or stroke 3. Peripheral vascular disease with foot ulcer and/or previous amputation 4. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and/or chronic atrial fibrillation 5. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalisation for decompensation; a requirement for mechanical ventilation at any stage; or long-term treatment with oral corticosteroids 6. Liver disease with abnormal liver function tests defined as serum bilirubin =20 µmol/L, and/or ALT =100 U/L, and/or GGT =100 U/L, and/or albumin <35 g/L 7. Haematological disorders, including haemoglobin =110 g/L or platelet count <80 x 109/L 8. Peptic ulcer disease and/or history of previous gastrointestinal bleeding 9. Malignancy other than basal cell carcinoma 10. History of epilepsy 11. Untreated hypothyroidism 12. Known adrenal insufficiency - History of drug, substance or alcohol abuse - Current oestrogen (e.g. cortisol) therapy - Any factor detected from psychometric evaluation at Visit 2 Pre-Tx during the screening period which may in the opinion of the Clinical Psychologist affect an individual's ability to fully participate in the study - Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, mental illness, or a history of non-adherence to appointments or treatments |
Country | Name | City | State |
---|---|---|---|
New Zealand | Centre for Clinical Research and Effective Practice | Auckland |
Lead Sponsor | Collaborator |
---|---|
Diatranz Otsuka Limited |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To establish the safety of xenotransplantation of DIABECELL(R) [immunoprotected (alginate-encapsulated) porcine islets] | 52 Weeks | ||
Primary | To establish preliminary evidence of the efficacy of DIABECELL(R), as measured by a reduction in serial HbA1C levels | 52 weeks | ||
Secondary | To establish whether DIABECELL(R) causes an improvement in glucose lability determined from continuous glucose monitoring | 52 Weeks | ||
Secondary | To determine whether DIABECELL(R) causes a reduction in hypoglycaemia and nocturnal hypoglycaemia | 52 Weeks | ||
Secondary | To determine whether DIABECELL(R) causes a reduction in insulin dose | 52 Weeks | ||
Secondary | To determine whether DIABECELL(R) causes an improvement in endogenous insulin secretion | 52 Weeks | ||
Secondary | To determine whether DIABECELL(R) causes an improvement in quality-of-life | 52 Weeks |
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