Open-label Investigation of the Safety and Effectiveness of DIABECELL® in Patients With Type 1 Diabetes Mellitus

NCT01739829 | Completed Phase 1 DMC

• 1 other identifier: LCT/DIA-09
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the safety and efficacy of xenotransplantation of DIABECELL® in patients with established type 1 diabetes mellitus

Conditions

Type 1 Diabetes

Keywords

xenotransplantation; type 1 diabetes; porcine islets

Outcome Measures

Primary Outcomes (1)

• To establish the safety and efficacy of xenotransplantation of DIABECELL

  * safety determined by occurence of hypoglycaemic events, occurence of perioperative reactions, occurence of adverse/serious adverse events, monitoring laboratory test results (including xenogeneic infection status), conducting physical examination, ECG * efficacy determined by change in HbA1c,daily insulin dose, transplant estimate function score, time spent in euglycaemia, occurence of hypoglycaemic events, quality of life assessment * the primary endpoint will be a reduction in the unaware hypoglycaemic event rate combined with no increase in HbA1c

  2 years

Study Arms (2)

DIABECELL group 1

EXPERIMENTAL

10,000 IEQ per kg body weight (Total Dose) Administered in two doses: 5,000 IEQ/kg three months apart.

Device: DIABECELL (R)

DIABECELL group 2

EXPERIMENTAL

20,000 IEQ per kg body weight (Total Dose) Administered in two doses: 10,000 IEQ/kg three months apart

Device: DIABECELL (R)

Interventions

DIABECELL (R) DEVICE

10,000 IEQ per kg body weight (Total Dose) Administered in two doses: 5,000 IEQ/kg three months apart.

DIABECELL group 1

Eligibility Criteria

• Age: 18 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 18 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 metabolic instability who cannot achieve acceptable metabolic control (which may include treatment with the use of a continuous insulin infusion pump) without experiencing multiple episodes of hypoglycaemia, often with unawareness
• Patients should have an HbA1C ≥7% and ≤15% 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 1.0%.
• Plasma C-peptide \<0.3 ng/ml following a glucagon stimulation test (Scheen et al. 1996)
• If female, no childbearing capability (those who are more than two years post menopausal 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 \>15% during the 8-week baseline run-in period
• Body mass index (BMI) ≥30 kg/m2 or ≤9 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, cholecystectomy or caesarean section
• 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 \>500 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)

Hospital Interzonal General de Agudos Eva Perón

Buenos Aires, Argentina

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

• Adrián Abalovich

  Eva Perón Hospital, San Martín

  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: November 26, 2012
• First Posted: December 4, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

AR (1)