UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007926 |
|---|---|
| Receipt number | R000008681 |
| Scientific Title | Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka |
| Date of disclosure of the study information | 2012/05/11 |
| Last modified on | 2012/05/06 18:57:06 |
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Basic information
Public title
Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka
Acronym
STGP-OSAKA
Scientific Title
Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka
Scientific Title:Acronym
STGP-OSAKA
Region
| Japan |
Condition
Condition
GAD-Ab positive non-insulin dependent diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of sitagliptin versus insulin on Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of patients indicated an insulin-dependent state during 3 years.
Rate of patients indicated an insulin-dependent state.
Key secondary outcomes
Change of HbA1c value.
Change of Fasted plasma glucose, Fasted serum CPR value.
Glucose level, glucagon level and C-peptide values during the liquid mixed-meal test.
Average amount of insulin per a day.
Rate of hypoglycemia. etc
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
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin group
Sitagliptine begin with 50 mg once daily (max dose 100mg).
Addition of metformin and/or alpha-GI are possible after increasing the dose of sitagliptine to 100mg.
Interventions/Control_2
Control group
Subcutaneous insulin administration to the control group patients. The dosage is adjusted.
If necessary, addition of metformin and/or alpha-GI are possible.
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 who met the criteria for diabetes mellitus.
1. Duration of diabetes should be within 5 yr from onset (or diagnosis).
2. GADAb positive: 1.5U/ml or higher
3. fasting serum C-peptide: 0.5ng/ml or higher
4. HbA1c(NGSP): <8.4%
FPG: <160mg/dl
Key exclusion criteria
1. Injection of insulin within 3 month before entry point
2. Pregnant or planning to be pregnant
3. Diabetic nephropathy: Class 3 or higher
4. Diabetic retinopathy:
Preproliferative or higher
5. NYHA 3-4
6. History in use of DPP-4 inhibitor or GLP-1 analogue.
7. Physician's judgment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Namba |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes and Metabolism, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-chi, Nishinomiya, Hyogo, 663-8501 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun-ichiro Miyagawa |
Organization
Hyogo college of medicine
Division name
Division of Diabetes and Metabolism, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-chi, Nishinomiya, Hyogo, 663-8501 Japan
TEL
0798-45-6111
Homepage URL
Sponsor or person
Institute
STGP-OSAKA study group
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Management information
Registered date
| 2012 | Year | 05 | Month | 10 | Day |
Last modified on
| 2012 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008681
| 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 |
