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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010176
Receipt No. R000011916
Scientific Title The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration
Date of disclosure of the study information 2013/03/06
Last modified on 2017/03/09

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Basic information
Public title The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration
Acronym The effects of combination therapy of Vildagliptin and Insulin on diabetes mellitus
Scientific Title The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration
Scientific Title:Acronym The effects of combination therapy of Vildagliptin and Insulin on diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of DPP-4 inhibitor, Vildagliptin, add-on to insulin therapy on glycemic control and diabetic complications in patients with type 2 diabetes mellitus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma glucose, HbA1c, diabetic retinopathy, diabetic nephropathy, cardiovascular disease, cerebral infarction, fracture, cancer
Key secondary outcomes

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 Vildagliptin, 50-100mg, once or twice/day, 5 years
Interventions/Control_2 no 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria type 2 diabetes mellitus with insulin therapy
Key exclusion criteria type 1 diabetes mellitus, severe liver injury, heart failure, pancreatitis, ileus
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ippei Kanazawa
Organization Shimane University Faculty of Medicine
Division name Endocrinology and Metabolism
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2183
Email ippei.k@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ippei Kanazawa
Organization Shimane University Faculty of Medicine
Division name Endocrinology and Metabolism
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2183
Homepage URL
Email ippei.k@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty 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
2013 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The baseline characteristics of subjects, including age, dose of insulin injections, or HbA1c levels, did not differ between the two groups. In the vildagliptin group, HbA1c levels significantly decreased and the significance of HbA1c reduction was maintained for 24 months (from 8.0% to 7.4%, p<0.05, at the end of observational period). In addition, the dose and number of insulin injections significantly reduced (-5.6 units, p<0.01, and -0.9 times, p<0.001). However, these parameters were unchanged in the control group. The number of patients who experienced three or more episodes of hypoglycemia per year was significantly lower in the vildagliptin group (n=4) than in the control group (n=11) (odds ratio, 0.28; 95% confidence interval, 0.08-0.97; p<0.05). 
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
2013 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 11 Month 15 Day
Date analysis concluded
2016 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 06 Day
Last modified on
2017 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011916

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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