UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for prevention of autoimmune non-insulin-dependent diabetes mellitus with sitagliptin (SPAN-S)
Title of the study (Brief title)	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	Takuya Awata
Organization	Saitama Medical University
Division name	Department of Endocrinology and Diabetes
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	Takuya Awata
Organization	Saitama Medical University
Division name	Department of Endocrinology and Diabetes
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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