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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004010
Receipt No. R000004821
Scientific Title Efficacy and safety of combination therapy with vildagliptin and nateglinide in type 2 diabetes.
Date of disclosure of the study information 2010/09/30
Last modified on 2013/06/19

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Basic information
Public title Efficacy and safety of combination therapy with vildagliptin and nateglinide in type 2 diabetes.
Acronym combination therapy of vildagliptin and nateglinide
Scientific Title Efficacy and safety of combination therapy with vildagliptin and nateglinide in type 2 diabetes.
Scientific Title:Acronym combination therapy of vildagliptin and nateglinide
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To comfirm the efficacy and safety of combination therapy with nateglinide and vildagliptin in comparison with vildagliptin monotherapy in type 2 diabetes whose nateglinide monotherapy is insufficiet.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of changes of HbA1c and meal loading test after 24 weeks treatment of combination therapy and monotherapy of vildagliptin
Key secondary outcomes Comparison of frequency of hypoglycemic episodes during 24 weeks treatment of combination therapy and monotherapy of vildagliptin.

Effects on glucagon and insulin secretion evaluated by meal loading test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination therapy with vildagliptin and nateglinide
Interventions/Control_2 monotherapy with vildagliptin
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 the patients whose HbA1c level is more than 6.5% and less than 8.4% even after diet, excise, and administration of nateglinide
Key exclusion criteria 1) type 1 diabetes
2) patients who has been prescribed sulfonylurea or alpha glucosidase inhibitor
3) patients who have serious liver disease (AST and/or ALT are more than 80IU/L)
4) patients who have serious kidney disease (Serum Cr is more than 1.5mg/dL)
5) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
6) patients who have serious pancreatic disease
7) patients with cancer
8) anemic patients (Hb is less than 11g/dL)
9) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
10) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
11) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
12) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus
13) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
14) patients who has the disease which is deteriorated with increase of gas in bowel
15) 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)
16) patients who are pregnant, hope to be pregnant, or are in lactation period
17) patients who have viral infection (HBV,HCV)
18) patients who are not applicable to this study judged by the medical doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose MD PhD
Organization Juntendo University Graduate School of Medicine
Division name Depart of Medicine, Metabolisam 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 Depart of Medicine, Metabolisam and Endocrinology
Zip code
Address
TEL
Homepage URL
Email hirosemd@juntendo.ac.jp

Sponsor
Institute Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Metabolism and Endocrinology, Juntendo University Graduate School of 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
2010 Year 09 Month 30 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 Completed
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 01 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
2010 Year 08 Month 06 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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