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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003693
Receipt No. 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

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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
Email 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
Email awata@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004417

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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