UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005076 |
|---|---|
| Receipt number | R000006040 |
| Scientific Title | Sitagliptin Use and its Continuous Glycemic Control Effcets in Japanese patients with type 2 diabetes in Saitama |
| Date of disclosure of the study information | 2011/02/14 |
| Last modified on | 2019/08/24 08:45:22 |
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Basic information
Public title
Sitagliptin Use and its Continuous Glycemic Control Effcets in Japanese patients with type 2 diabetes in Saitama
Acronym
SUCCEED trial
Scientific Title
Sitagliptin Use and its Continuous Glycemic Control Effcets in Japanese patients with type 2 diabetes in Saitama
Scientific Title:Acronym
SUCCEED trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of sitagliptin monotherapy in maintaining long-term glycemic control in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To achieve HbA1c less than 7.0% (JDS values) at 12 weeks after treatment with sitagliptin
2. The time to monotherapy failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration: 104 weeks
Therapy: Sitagliptin 50 mg/day
Interventions/Control_2
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 the ages of more than 20 years.
2. Patients who do not recieve any anti-diabetic agent within 1 month.
3. HbA1c levels (JDS values) ranging from 6.5 to 7.9 % at baseline.
4. Both outpatients and inpatients
Key exclusion criteria
1. Patients with type 1 diabetes
2. Renal impairment (Serum creatinine more than 1.5 mg/dl in men or 1.3 mg/dl in women)
4. Patients who undergo surgery
5. Preganat women
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Aso |
Organization
Dokkyo Medical University,
Koshigaya Hospital
Division name
Internal Medicine
Zip code
343-8555
Address
2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL
048-965-111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Takebayashi |
Organization
Dokkyo Medical University,
Division name
Internal Medicine
Zip code
343-8555
Address
2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Homepage URL
takebaya@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University,Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University,Koshigaya Hopital
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
Saitama Medical Center, Dokkyo Medical University
Address
2-1-50 Minami Koshigaya, Koshigaya
Tel
048-965-1111
yaso@dokkyomed.ac.jp
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
| 2011 | Year | 02 | Month | 14 | 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
50
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 | 01 | Month | 19 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006040
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
