UMIN-CTR Clinical Trial

Basic information
Public title	Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness
Acronym	Islet transplantation using brain-dead donors and donors after cardiac death for type 1 diabetes
Scientific Title	Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness
Scientific Title:Acronym	Islet transplantation using brain-dead donors and donors after cardiac death for type 1 diabetes
Region	Japan

Condition
Condition	Type 1 diabetes
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary objective is to verify the effect of the immunosuppressants by confirming the existing islet graft function that can lead to glycemic stability. The secondary objective is to confirm the safety of using these immunosuppressants for long periods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The proportion of subjects with HbA1c<7.0% and who are free of severe hypoglycemic events (from day 90 to day 365) one years after the first islet cell infusion.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Immunosuppressant
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Male or female; 20 to 65 years of age. 2. Ability to provide written informed consent. 3. Mentally stable and able to comply with the procedures of the study protocol. 4. Clinical history compatible with type 1 diabetes with insulin dependence for > 5 years at the time of the registration. 5. Absent stimulated C-peptide (< 0.3 ng/mL) 6. Involvement in intensive diabetes management defined as the self monitoring of glucose values no less than a mean of three times each day, averaged over each week, and the administration of three or more insulin injections each day or insulin pump therapy. Such management must have been subjected to at least 3 clinical evaluations during the previous 12 months. 7. At least one episode of severe hypoglycemia in the past 12 months defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level < 54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. 8. At least once evaluated glycemic lability status by a Clarke score, a HYPO score and a glycemic lability index (LI) score.
Key exclusion criteria	1. BMI > 27 kg/m2 or weight > 80 kg. 2. Insulin requirement of > 0.8 IU/kg/day or 55 U/day. 3. Mean HbA1c value of several measurements in the previous 12 months > 10%. 4. Untreated proliferative diabetic retinopathy. 5. Blood pressure: SBP > 160 mmHg or DBP > 100 mmHg. 6. Creatinine clearance < 60 mL/min (applied only to islet transplantation alone case) 7. Presence of proteinuria > 1 g/day. 8. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: Intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 9. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation. 10. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 11. Difficulty of administration for laboratory and physical tests for evaluation or regular outpatient visits. 12. Mental abnormalities to hinder medical procedure under protocol (Assessment by psychiatrists is required and final decision is made by investigators in charge) 13. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shigeru Marubashi
Organization	Fukushima Medical University
Division name	Department of Hepato-Biliary-Pancreatic Surgery
Zip code
Address	1 Hikarigaoka Fukushima, Japan
TEL	024-547-1254
Email	jpitx@fmu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takayuki Anazawa
Organization	Fukushima Medical University/Kyoto University
Division name	Department of Regenerative Surgery/Department of Surgery
Zip code
Address	1 Hikarigaoka Fukushima, Japan
TEL	024-547-1254
Homepage URL
Email	anazawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute	The Japanese Pancreas and Islet Transplantation Association
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 08 Month 02 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004768

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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