UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003693 |
|---|---|
| Receipt number | R000004417 |
| Scientific Title | Study for prevention of autoimmune non-insulin-dependent diabetes mellitus with sitagliptin (SPAN-S) |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2018/10/12 08:41:14 |
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Basic information
Public title
Study for prevention of autoimmune non-insulin-dependent diabetes mellitus with sitagliptin (SPAN-S)
Acronym
SPAN-S
Scientific Title
Study for prevention of autoimmune non-insulin-dependent diabetes mellitus with sitagliptin (SPAN-S)
Scientific Title:Acronym
SPAN-S
Region
| Japan |
Condition
Condition
Diabetes mellitus (GAD Ab positive non-insulin dependent diabetes mellitus)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of sitagliptine on patients with GAD antibody-positive non-insulin dependent diabetes mellitus in comparison with pioglitazone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c values, and fraction and period from registration of patients whose HbA1c values become 9.4 %(NGSP) or above
Key secondary outcomes
glucose and C-peptide values in annual 75 g OGTTs
body weight
blood pressure
islet autoantibodies (GAD Ab, IA-2 Ab, IAA, ZnT8 Ab)
fasting glucose values
fasting C-peptide values
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Intervention group
Sitagliptine (start 50mg, maximum 100mg) with the previous dibetes treatments. Addition of metformin or alpha-glucosidase inhibitor is possible after increasing the dose of sitagliptine to 100mg. Target HbA1c is below 6.9%(NGSP); if HbA1c is 9.4%(NGSP) or over, the trial terminates in the patient.
In principle, 5 years follow-up with annual evaluation by an independent monitoring committee.
Interventions/Control_2
2. Control group
Pioglitazone (start 15mg, maximum 30mg) with the previous dibetes treatments. Addition of metformin or alpha-glucosidase inhibitor is possible after increasing the dose of pioglitazone to 30mg. Target HbA1c is below 6.9%(NGSP); if HbA1c is 9.4%(NGSP) or over, the trial terminates in the patient.
In principle, 5 years follow-up with annual evaluation by an independent monitoring committee.
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
HbA1c: 6.9-8.4%(NGSP)
GAD Ab positive
fasting serum C-peptide: 1.0ng/ml or higher
duration: 6 months-5 years
age: 20 years-79 years
medication for diabetes: none or biguanide only at least 2 months before registration
Key exclusion criteria
pregnant or planning to be pregnant
moderate renal dysfunction: Ccr < or = 50 mL/min, or serum Cr > or = 1.5 mg/dL (male) or 1.3 mg/dL (female)
severe complication that is inappropriate for trial
physician's judgement
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Awata |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama, Japan 350-0495
TEL
049-276-1204
awata@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Awata |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama, Japan 350-0495
TEL
049-276-1204
Homepage URL
awata@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004417
| Research Plan | |
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| 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 |
