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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012302
Receipt No. R000014387
Scientific Title The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Date of disclosure of the study information 2013/11/20
Last modified on 2013/11/15

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Basic information
Public title The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Acronym The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Scientific Title The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Scientific Title:Acronym The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of drugs using markers for glucose metabolism
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the value of makers for glycemic control
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Drug administration
Interventions/Control_2 Drug administration
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients medicated with insulin Aspart
2. HbA1c value 7.0%-11%, type 2 diabetic patients
Key exclusion criteria 1) Patients with hypersensitivity to insulin Aspart and/or Lispro.
2) Patients with surgical operation, trauma or infection.
3) Patients who are pregnant
4) Patients with severe renal or liver failure
5) Patients with pituitary insufficiency or adrenal insufficiency.
6) Patients with diarrhea or vomit
7) Patients with heavy exercise
8) Juged as ineligible by clinical investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaya Matsushita
Organization Tokyo Medical University Hachioji Medical Center
Division name Diabetology, Endocrinology and Metabolism
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo, 193-0998, Japan
TEL 042-665-5611
Email tmatsush@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaya Matsushita
Organization Tokyo Medical University Hachioji Medical Center
Division name Diabetology, Endocrinology and Metabolism
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo, 193-0998, Japan
TEL 042-665-5611
Homepage URL
Email tmatsush@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hachioji Medical Center
Institute
Department

Funding Source
Organization Tokyo Medical University Hachioji Medical Center
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 東京医科大学八王子医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2013 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 20 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
2013 Year 11 Month 15 Day
Last modified on
2013 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014387

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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