UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005627 |
|---|---|
| Receipt number | R000006649 |
| Scientific Title | Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes -prospective open-label controlled study- |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2013/12/07 13:30:33 |
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Basic information
Public title
Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
-prospective open-label controlled study-
Acronym
Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
Scientific Title
Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
-prospective open-label controlled study-
Scientific Title:Acronym
Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
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 evaluate the effects of switching from sitagliptin to vildagliptin on glucose fluctuations in patients with type 2 diabetes, and vice versa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate changes in MAGE; mean amplitude of glycemic excursions before and after switching from sitagliptin to vildagliptin, and vice versa
Key secondary outcomes
1) M-value
2) fasting plasma glucose, HbA1c, glycoalbumin
3) beta cell function
4) changes in body weight, Body Mass Index, abdominal girth, blood pressure
5) several biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Interventions/Control_2
sitagliptin
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, once daily) or vildagliptin(50mg, twice daily) for more than 3 months
2) HbA1c 5.8-7.9% (JDS), HbA1c 6.2-8.3%(NGSP)
3) written informed consent
Key exclusion criteria
1) patients who received insulin injection therapy
2) severe hepatic dysfunction, renal dysfunction, heart failure
3) history of anaphylaxis of Sitagliptin or Vildagliptin,
4) pregnancy and lactation
5) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine II,
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
北海道大学病院（北海道）、クラーク病院（北海道）、栗原内科（北海道）、沖医院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 22 | Day |
Last modified on
| 2013 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006649
