UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003840 |
|---|---|
| Receipt number | 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 18:38:30 |
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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
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
ysaisho@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Medicine
Division of Nephrology, Endocrinology and Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004526
