UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035730
Receipt number R000040686
Scientific Title Clinical trial of D-psicose in patients with type 2 diabetes
Date of disclosure of the study information 2019/01/31
Last modified on 2019/01/31 15:16:19

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Basic information

Public title

Clinical trial of D-psicose in patients with type 2 diabetes

Acronym

Clinical trial of D-psicose

Scientific Title

Clinical trial of D-psicose in patients with type 2 diabetes

Scientific Title:Acronym

Clinical trial of D-psicose

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

D-psicose is administered to patients with type 2 diabetes, and comprehensively analyzes the patient's background, treatment course, etc. to obtain knowledge about appropriate administration subjects of D-psicose.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change amount of HbA1c value at the 12th week after administration from the start of administration

Key secondary outcomes

Change in fasting blood glucose level or 2-hour postprandial blood glucose level and other blood test items


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

Food

Interventions/Control_1

D-psicose is orally administered 15 g / day

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

Type 2 diabetes patients (HbA1c 6.5% or more) who can not obtain sufficient effect by any of the following treatments
1) Diet therapy or exercise therapy only
2) Pharmacotherapy in addition to diet therapy and exercise therapy

Key exclusion criteria

1) Patients falling under D-psicose administration contraindications
2) Patients participating in other clinical trials
3) A pregnant woman, a maternity woman, a lactating woman or a woman having a possibility of pregnancy
4) Patients who have poor glycemic control with HbA1c> 8%
5) Patients who have severe renal dysfunction (serum creatinine value> 1.5 mg / dl)
6) Patients with other serious complications
7) Other patients judged inappropriate for judgment by other doctor's judgment

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name koji murao

Organization

kagawa university

Division name

Department of Endocrinology and Metabolism, Faculty of Medicine

Zip code


Address

1750-1, Miki-Cho, Kita-Gun, Kagawa, 761-0793 Japan

TEL

+81878912230

Email

labmed@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name koji murao

Organization

kagawa university

Division name

Department of Endocrinology and Metabolism, Faculty of Medicine

Zip code


Address

1750-1, Miki-Cho, Kita-Gun, Kagawa, 761-0793 Japan

TEL

+81878912230

Homepage URL


Email

labmed@med.kagawa-u.ac.jp


Sponsor or person

Institute

kagawa university

Institute

Department

Personal name



Funding Source

Organization

kagawa 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


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

2019 Year 01 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


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

Completed

Date of protocol fixation

2011 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 31 Day

Last modified on

2019 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name