UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003977
Receipt number R000004768
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
Date of disclosure of the study information 2010/11/01
Last modified on 2021/04/18 19:19:45

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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

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Marubashi

Organization

Fukushima Medical University

Division name

Department of Hepato-Biliary-Pancreatic Surgery

Zip code

960-1295

Address

1 Hikarigaoka Fukushima, Japan

TEL

024-547-1254

Email

jpitx@fmu.ac.jp


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Anazawa

Organization

Fukushima Medical University/Kyoto University

Division name

Department of Regenerative Surgery/Department of Surgery

Zip code

960-1295

Address

1 Hikarigaoka Fukushima, Japan

TEL

024-547-1254

Homepage URL


Email

anazawa@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

The Japanese Pancreas and Islet Transplantation Association

Institute

Department

Personal name



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

Fukushima Medical University

Address

Hikarigaoka 1 Fukushima

Tel

024547111

Email

rs@fmu.ac.jp


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

9

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data analysis in progress

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

Terminated

Date of protocol fixation

2010 Year 11 Month 01 Day

Date of IRB

2011 Year 06 Month 01 Day

Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2021 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 08 Month 02 Day

Last modified on

2021 Year 04 Month 18 Day



Link to view the page

Value
https://center6.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