UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Acronym	Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Scientific Title	Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Scientific Title:Acronym	Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Region	Japan

Condition
Condition	type 1 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of high-dose vitamin B12 treatment in type 1 diabetic patient with impaired awareness of hypoglycemia accompanied with autonomic dysfunction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms of hypoglycemia in an insulin tolerance test(Day 21~28)).
Key secondary outcomes	Autonomic function(coefficient of variation of R-R interval, Schellong test) Epinephrine, norepinephrine, dopamine, cortisol, ACTH, growth hormone, glucagon

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	Vitamin B12 intramuscularly injection 1mg per day for 3 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Type 1 diabetes(Eligible participants had a known history of type 1 diabetes for at least 6 months, and had been treated for at least 6 months with a basal-bolus insulin regimen) 2)Treatment with multiple insulin injection 3)Hypoglycemia unawareness 4)Autonomic dysfunction
Key exclusion criteria	1)Patients younger than 19 years old. 2)Severe liver dysfunction 3)Severe renal failure 4)Pregnant 5)Angina pectoris,epilepsy,preproliferative diabetic retinopathy(PPDR) and proliferative diabetic retinopathy(PDR) 6)Judged as ineligible by clinical investigators
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Kozawa
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Metabolic Medicine
Zip code	5650871
Address	2-2-B5,Yamadaoka,Suita city,Osaka
TEL	06-6879-3732
Email	kjunji@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Fujita
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Metabolic Medicine
Zip code	565-0871
Address	2-2-B5,Yamadaoka,Suita city,Osaka
TEL	06-6879-3732
Homepage URL
Email	lutefs222@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Osaka University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Graduate School of Medicine, Osaka University
Address	B5, 2, 2-1-1 Yamadaoka Suita
Tel	06-6879-5111
Email	lutefs222@endmet.med.osaka-u.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	2017 Year 03 Month 31 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	1
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	Terminated
Date of protocol fixation	2017 Year 03 Month 31 Day
Date of IRB	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 03 Month 31 Day
Last follow-up date	2019 Year 06 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 01 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030190