UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006765 |
|---|---|
| Receipt number | R000007973 |
| Scientific Title | Sulfonylurea therapy added on type 2 diabetes patients with poorly controlled insulin therapy in Juntendo |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2012/11/24 09:06:15 |
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Basic information
Public title
Sulfonylurea therapy added on type 2 diabetes patients with poorly controlled insulin therapy in Juntendo
Acronym
START-J
Scientific Title
Sulfonylurea therapy added on type 2 diabetes patients with poorly controlled insulin therapy in Juntendo
Scientific Title:Acronym
START-J
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of glimepiride on glycemic control, safety, function of pancreatic beta-cell, and atherosclerosis in the type 2 diabetes patients with inadequate insulin therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. efficacy of addition of glimepiride on glyceic control
2. influence of addition of glimepiride on pancreatic beta cell function
3. preventive effect of addition of glimepiride on atherosclerosis (Using IMT as surrogate endopoint)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
addition of glimepiride in insulin therapy
Interventions/Control_2
no addition of glimepiride
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 2 diabetes patients whose glycated hemoglobin level are between 7.0 and 10.0 %
2)glycated hemoglobin level were stable during last three months (-0.5 to 0.5%)
3)subjects who are already performing diet and exercise therapy for 6 months
4)subjects who were prescribed insulin for more than 6 months but not done sulfonylurea.
5)no ristriction on the drugs already prescribed. It is possible to add any drug other than sulfonylurea and change dose to avoid adverse effects like hypoglycemia according to the dicision of physician in attendance.
6)subjects who chan understand informed consent
Key exclusion criteria
1) type 1 diabetes
2) patients who have serious liver disease (AST and/or ALT are more than 100IU/L)
3) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL)
4) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
5) patients who have serious pancreatic disease
6) patients with cancer
7) anemic patients (Hb is less than 11g/dL)
8) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
9) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
10) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
11) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus
12) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
13) patients who has the disease which is deteriorated with increase of gas in bowel
14) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day)
15) patients who are pregnant, hope to be pregnant, or are in lactation period
16) patients who have viral infection (HBV,HCV)
17) patients who are not applicable to this study judged by the medical doctor.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAHISA HIROSE |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept. of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept of Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
hirosemd@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate Schoolof Medicine.
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate Schoolof Medicine.
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
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
| 2012 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 24 | Day |
Last modified on
| 2012 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007973
