Open-label Investigation of the Safety and Effectiveness of DIABECELL(R) in Patients With Type I Diabetes Mellitus

NCT00940173 | Completed Phase 1 DMC

• 1 other identifier: LCT/DIA-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

xenotransplantation; type I diabetes; porcine islets

Outcome Measures

Primary Outcomes (2)

• To establish the safety of xenotransplantation of DIABECELL(R) [immunoprotected (alginate-encapsulated) porcine islets]

  52 Weeks

• To establish preliminary evidence of the efficacy of DIABECELL(R), as measured by a reduction in serial HbA1C levels

  52 weeks

Secondary Outcomes (5)

• To establish whether DIABECELL(R) causes an improvement in glucose lability determined from continuous glucose monitoring

  52 Weeks

• To determine whether DIABECELL(R) causes a reduction in hypoglycaemia and nocturnal hypoglycaemia

  52 Weeks

• To determine whether DIABECELL(R) causes a reduction in insulin dose

  52 Weeks

• To determine whether DIABECELL(R) causes an improvement in endogenous insulin secretion

  52 Weeks

• To determine whether DIABECELL(R) causes an improvement in quality-of-life

  52 Weeks

Study Arms (4)

Group 1

OTHER

Dose Group 1 (Receiving a dose of 10,000 IEQ/kg of DIABECELL(R))

Device: DIABECELL(R)

Group 2

OTHER

Dose Group 2 (Receiving a dose of 15,000 IEQ/kg of DIABECELL(R))

Device: DIABECELL(R)

Group 3

OTHER

Dose Group 3 (Receiving a dose of 20,000 IEQ/kg of DIABECELL(R))

Device: DIABECELL(R)

Group 4

OTHER

Dose Group 4 (Receiving a dose of 5,000 IEQ/kg of DIABECELL(R))

Device: DIABECELL(R)

Interventions

DIABECELL(R) DEVICE

10,000 IEQ/kg injected into the peritoneal cavity via laparoscopy

Group 1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diatranz Otsuka Limited: lead

Study Sites (1)

Centre for Clinical Research and Effective Practice

Auckland, New Zealand

Location

Related Links

• Diatranz Otsuka Limited

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John Baker, MB ChB

  Centre for Clinical Research and Effective Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2009
• First Posted: July 15, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

NZ (1)