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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003989
Receipt No. R000004713
Scientific Title Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial
Date of disclosure of the study information 2010/11/11
Last modified on 2019/08/10

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Basic information
Public title Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial
Acronym Saitama Sitagliptin Study (3S)
Scientific Title Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial
Scientific Title:Acronym Saitama Sitagliptin Study (3S)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare effects of sitagliptin addition with sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Serum C peptide concentration
Intact proinsulin/insulin ratio
Key secondary outcomes HbA1c, fasting plasma glucose, HOMA-beta LDL cholesterol, HDL chplesterol, triglyceride, urinary albumin, cystatin C, high sensitivity C-reactive protein, high molecular weight adiponectin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
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 Glimepiride at a dose of 1 mg plus sitagliptin group
Interventions/Control_2 Glimepiride intesification group
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
75 years-old >
Gender Male and Female
Key inclusion criteria Inadequately controlled type 2 diabetic patients who are taking sulfonylurea (glymepiride at a dose of 1 mg to 2 mg)for more than 1 month.

Patients whose HbA1c ranges from 7.0% to 9.0% (JDS value).
Key exclusion criteria 1. Patients who had diabetic ketoacidosis, or diabetic pre- and coma within 6 months of the study entry.
2. Patients who received surgery operation during the study.
3. Patients with pregnancy or Nursing mothers
4. Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5. Patients who received insulin therapy
6. Patients who had a history of hypersensitivity reaction to sitagliptin
7. Patients whom the attending doctor estimated to be ineligible according to the medical rationale.

Target sample size 240

Research contact person
Name of lead principal investigator
1st name Shigehiro
Middle name
Last name Katayama
Organization Saitama Medical University
Division name Department of Endocrinology and Diabetes
Zip code 350-0495
Address 38 Morohongo, Moroyama, Iruma-gun, Saitama 350-0495,Japan
TEL 049-276-1204
Email skataya@saitama-med.ac.jp

Public contact
Name of contact person
1st name Yoshimasa
Middle name
Last name Aso
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code 321-0293
Address 880 Kita-Kobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email yaso@dokkyomed.ac.jp

Sponsor
Institute Saitama Sitagliptin Study (3S)
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan Inc
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sitama Medical University IRB
Address 38 Morohongo, Moroyama, Iruma-gun, Saitama 350-0495,Japan
Tel 049-276-1111
Email skataya@saitama-med.ac.jp

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 埼玉医科大学病院(埼玉県)、埼玉医科大学総合医療センター(埼玉県)、
防衛医科大学校病院(埼玉県)、自治医科大学附属さいたま医療センター(埼玉県)
獨協医科大学越谷病院(埼玉県)、西埼玉中央病院(埼玉県)
埼玉社会保険病院(埼玉県)、さいたま赤十字病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 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 Open public recruiting
Date of protocol fixation
2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2019 Year 02 Month 08 Day
Date trial data considered complete
2019 Year 02 Month 08 Day
Date analysis concluded
2019 Year 02 Month 08 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004713

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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