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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003840
Receipt No. R000004526
Scientific Title Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Date of disclosure of the study information 2010/07/01
Last modified on 2016/02/18

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Basic information
Public title Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Acronym Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Scientific Title Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Scientific Title:Acronym Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Region
Japan

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

Objectives
Narrative objectives1 We examine the safety and efficacy of mitiglinide for type 2 diabetic patients with suboptimal glycemic control who were treated with diet therapy and/or non-insulin secretagogues
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes HbA1c
Key secondary outcomes fasting plasma glucose, C-peptide, insulin, proinsulin, glycoalbumin, 1,5-AG, serum lipid profile, body weight, adverse events, oxidative stress markers, inflammatory markers, daily capillary glucose profile

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 Mitiglinide 10mg three times daily will be added for 4 months. If the glycemic control are suboptimal (HbA1c(JDS) 6.5% or more) 2 month after the treatment, the patients will be treated with mitiglinide 20mg three times daily.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes inadequately controlled (HbA1c 6.5% or more) with diet therapy or non-insulin secretagogues
Key exclusion criteria 1) Patients with pretreatment with sulfonyl urea within 3 months
2) Patients who need insulin therapy for the treatment of type 2 diabetes
3) Patients with severe liver dysfunction (AST and/or ALT 100IU/l or more)
4) Patients with severe renal dysfunction (Cr 2.5mg/dl or more) or patients under hemodialysis
5) Patients with uncontrolled hypertension (SBP 180mmHg or more, and/or DBP 110mmHg or more)
6) Patients with severe heart disease
7) Patients with onset of cardiovascular disease within 3 months
8) Patients with malignancy
9) Patients with allergy for glinide
10) Patients with pregnancy
11) Patients whom the doctors do not allow to participate the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Saisho
Organization Keio University School of Medicine
Division name Department of Medicine
Zip code
Address 35 Shinanomachi Shinjukuku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Saisho
Organization Keio University School of Medicine
Division name Department of Medicine
Zip code
Address 35 Shinanomachi Shinjukuku Tokyo
TEL 03-5363-3797
Homepage URL
Email ysaisho@z5.keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Medicine
Division of Nephrology, Endocrinology and Metabolism
Institute
Department

Funding Source
Organization Kissei Pharmaceutical CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 06 Month 29 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004526

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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