UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010376 |
|---|---|
| Receipt number | R000012141 |
| Scientific Title | Sitagliptin Trial For Safety And Efficacy In Elderly Patients With Moderately Controlled Type 2 Diabetes |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2016/10/19 23:31:38 |
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Basic information
Public title
Sitagliptin Trial For Safety And Efficacy In Elderly Patients
With Moderately Controlled Type 2 Diabetes
Acronym
Stream Study
Scientific Title
Sitagliptin Trial For Safety And Efficacy In Elderly Patients
With Moderately Controlled Type 2 Diabetes
Scientific Title:Acronym
Stream Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of sitagliptin in elderly patients with type 2 diabetes will be investigated prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the HbA1c level and safety at 3, 6, and 12 months after study initiation
Key secondary outcomes
Blood glucose level at 3, 6, and 12 months after study initiation,
Glycated albumin,Proinsulin/insulin ratio,Body weight,
Course of diabetic complications,
Hematology,
Immunological 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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin group
Interventions/Control_2
Non-sitagliptin group (conventional treatment group)
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes meeting all of the following conditions:
(1) Age :>=65 and <80 years old at the time of participation in the study
(2)A NGSP HbA1c level :>=7.4% and <10.5% at the time of participation in the study
(3) A stable HbA1c level (variation: within 1.0%) for 2 months before participation in the study
(4) Patients with insufficient glucose control (meeting item (2) above) after treatment with dietary/exercise therapy or oral blood glucose-lowering agents (excluding glinide drugs which is not accepted of the combination)
(5) Patients who give written consent
Key exclusion criteria
(1) Patients with type 1 diabetes
(2) Patients under treatment with insulin
(3) Patients under treatment with GLP-1 injection, a DPP4 inhibitor, or an investigational drug
(4) Patients with severe renal dysfunction (eGFR: <30 mL/min), including those under treatment with dialysis
(5) Patients judged to be ineligible by a physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oikawa |
Organization
Nippon Medical School Hospital
Division name
Division of Endocrinology and Metabolism, Department of Medicine
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku Tokyo
TEL
03-3822-2131
shinichi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugihara |
Organization
Nippon Medical School Hospital
Division name
Division of Endocrinology and Metabolism, Department of Medicine
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku Tokyo
TEL
03-3822-2131
Homepage URL
hitoshi@nms.ac.jp
Sponsor or person
Institute
STREAM research group
Institute
Department
Personal name
Funding Source
Organization
Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2013 | Year | 04 | 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
| 2012 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 09 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
