UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004010 |
|---|---|
| Receipt number | 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 11:51:03 |
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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
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
hirosemd@juntendo.ac.jp
Sponsor or person
Institute
Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004821
