UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005291 |
|---|---|
| Receipt number | R000006294 |
| Scientific Title | The long-term efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in patients with type 2 diabetes, who had been treated with a glinid. |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/03/23 11:52:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The long-term efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in patients with type 2 diabetes, who had been treated with a glinid.
Acronym
SINGLE Study 2 (Extension Study)
Scientific Title
The long-term efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in patients with type 2 diabetes, who had been treated with a glinid.
Scientific Title:Acronym
SINGLE Study 2 (Extension Study)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long term efficacy and safety of sitagliptin in patients with type 2 diabetes, who had been treated with a glinide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, Glycoalbumin, 1,5-AG, plasma glucose
Key secondary outcomes
Serum C-peptide, IRI, IRG, HOMA, SUIT index, CPR index, proinsulin/insulin, Body weight
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes treated with sitagliptin.
Patients enrolled in the SINGLE Study.
Key exclusion criteria
Patients with moderate to severe renal insufficiency
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Tanaka |
Organization
Mie Chuo Medical Center (Mie Pref fecture)
Division name
Department of internal medicine
Zip code
Address
2158-5 hisai-myoujin-tyo, Tsu, Mie Pref. 514-1101
TEL
059-259-1159
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Mie Chuo Medical Center (Mie Pref fecture)
Division name
Department of internal medicine
Zip code
Address
2158-5 hisai-myoujin-tyo, Tsu, Mie Pref. 514-1101
TEL
059-259-1159
Homepage URL
Sponsor or person
Institute
Mie Chuo Medical Center (Mie Pref fecture)
Institute
Department
Personal name
Funding Source
Organization
Mie Chuo Medical Center (Mie Pref fecture)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamada Red Cross Hospital (Mie Pref.)
National Mie Hospital (Mie Pref.)
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
| 2011 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HbA1c, Glycoalbumin, 1,5-AG, plasma glucose, meal tolerance test and adverse event
Management information
Registered date
| 2011 | Year | 03 | Month | 23 | Day |
Last modified on
| 2011 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
