UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008815
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ehirata11@gmail.com

Sponsor
Institute Department of Medicine and Bioregulatory,Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.