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


Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name