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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007926
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute STGP-OSAKA study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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