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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010199
Receipt No. R000011946
Scientific Title Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Date of disclosure of the study information 2013/03/31
Last modified on 2014/09/09

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Basic information
Public title Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Acronym Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Scientific Title Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Scientific Title:Acronym Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the continuous glucose profiles byincreasing dose of sitagliptin or switching from sitagliptin to vildagliptin in patients with type 2 diabetes treated with sitagliptin and insulin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes MAGE; mean amplitude of glycemic excursions
Key secondary outcomes 1) M-value 2) glucose area under the curve 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sitagliptin
Interventions/Control_2 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 1) patients with type 2 diabetes using sitagliptin (50mg) and insulin for more than 3 months
2) HbA1c 6.2-8.4% (NGSP)
3) written informed consent
Key exclusion criteria 1) severe hepatic dysfunction, renal dysfunction, heart failure.
2) history of anaphylaxis of sitagliptin or vildagliptin.
3) pregnancy.
4) patients who are inadequate to enter this study due to the other reasons by physician's judgments.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2013 Year 03 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 Completed
Date of protocol fixation
2013 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 31 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
2013 Year 03 Month 09 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011946

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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