UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008815 |
|---|---|
| Receipt number | R000010271 |
| Scientific Title | The effect of DPP-4 inhibitor on pancreatic beta cell function and renal function in type 2 diabetic patients |
| Date of disclosure of the study information | 2012/08/31 |
| Last modified on | 2015/03/30 10:36:15 |
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Basic information
Public title
The effect of DPP-4 inhibitor on pancreatic beta cell function and renal function in type 2 diabetic patients
Acronym
Kyushu Sitagliptin intervention trial for Preservation of Insulin secretion and Renal function In Type 2 diabetic patients (K-SPIRIT Study)
Scientific Title
The effect of DPP-4 inhibitor on pancreatic beta cell function and renal function in type 2 diabetic patients
Scientific Title:Acronym
Kyushu Sitagliptin intervention trial for Preservation of Insulin secretion and Renal function In Type 2 diabetic patients (K-SPIRIT Study)
Region
| Japan |
Condition
Condition
Type 2 Diabetes millitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of sitagliptin versus glimepiride on pancreatic beta-cell protection and renal function for type 2 diabetic patient inadequately controlled by metformin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the ratio and amount of change of proinsulin/IRI ratio in 12 months from the start of treatment.
the ratio and amount of change of urinary microalbumin in the three-month average of 10,11,12 months after from the start of treatment.
Key secondary outcomes
the amount and rate of change of proinsulin/IRI ratio in 6 months from the start of treatment.
the ratio and amount of change of urinary microalbumin in the three-month average between one and 12 months after from the start of treatment.
the ratio and amount of change between one and 12months from the start treatment
HbA1c
fasting plasma glucose
1,5AG
the ratio and amount of change of eGFR in 3, 6, 9, 12 months from the start of treatment
the ratio and amount of change in 6, 12 months from the start of treatment
hs-CRP
macromolecular adiponectin
8-isoprostan
glucagon
bilirubin level
the ratio and amount of change between one and 12 months from the start of treatment
the period of the starat of insulin treatment
body weight change
frequency of hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin 50mg/day add to metformin
(the patients with type 2 diabetes (6.2%<= HbA1c(JDS) <=10.0%) taking with metformin 500-750mg for more than 1 month treatments)
Interventions/Control_2
glimepiride 1mg/day add to metformin
(the patients with type 2 diabetes (6.2%<= HbA1c(JDS) <=10.0%) taking with metformin 500-750mg for more than 1 month treatments)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with type 2 diabetes (6.2%<= HbA1c(JDS) <=10.0%) taking with metformin for more than 1 month treatments.
2.Patients with the age between 20-75 years old
3.Sex: Unquestioned
4.Patients who agreed with the participation in this study with written consent
Key exclusion criteria
1. Diabetic coma, diabetic ketoacidosis and type 1 patients
2.Patients with the severe renal impairment.(Serum creatinine >=1.5mg/dl in men and >=1.3mg/dl in women)
3.Patients with liver disfunction(ALT surpasses 3 times of normal upper limit)
4.Patient who has digestive trouble
5. In emergency cases such as severe infection and surgery
6.Patients with a history of lactic acidosis
7.The patient who has the state of being easy to be accompanied by the patient and hypoxemia which have an advanced obstacle in cardiovascular systems, such as a shock, heart failure, myocardial infarction, and pulmonary embolism, and a pulmonary function.
8.Patient Who Has Dehydration
9.Alcoholic Excessive Ingestion Patient
10.Patient of Poor Nutritional Status, Starvation, Debility State, Hypophysis Malfunction, or Adrenal-Function Insufficiency
11.Pregnant Woman or Woman that May Have Become Pregnant
12.Patients treated with Insulin preparation, alfa-glycosidase inhibitor (alfa-GI), insulin secretagogue (glinide)
13.Patient Who Has Anamnesis of Hypersensitivity to Medicine of Ingredient of Research Medicine, or the Same Action Mechanism of the Research Medicine
14.Patient Whom Family Doctor Made Unsuitable to Research Participation from Medical Rationale
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Takayanagi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5284
ehirata11@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoshi Inoguchi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5284
Homepage URL
ehirata11@gmail.com
Sponsor or person
Institute
Department of Medicine and Bioregulatory,Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
The clinical Research Promotion foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010271
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| Registered date | File name |
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| Registered date | File name |
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