UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus
Title of the study (Brief title)	Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus (JAMP study)
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In Japanese patients with type 2 diabetes mellitus who had uncontrolled blood glucose, the effects of a DPP-4 inhibitor (sitagliptin) on HbA1c and other efficacy parameters as well as safety is to be prospectively investigated. In addition, after completion of the study period, subanalyses stratifying patients by factors such as complications, concomitant drugs and a history of diabetes are to be conducted to determine patients who are more likely to respond to glucose lowering therapy with sitagliptin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HbA1c after 3 months of treatment from baseline
Key secondary outcomes	1) The following parameters at baseline, and 1, 3, and 12 months after treatment - Percentage of patients with normal HbA1c level - Percentage of patients with normal fasting blood glucose level 2) Change in the following parameters after 1,3,and 12 months of treatment from baseline - HbA1c (except the value after 3 months) - Fasting blood glucose - HOMA-beta - lipids (LDL-C, TG, and HDL-C) 3) Safety throughout the study period - Incidence of adverse reactions / incidence of hypoglycemia 4) Exploratory analysis Subanalyses stratifying patients by factors including response to sitagliptin, complications, concomitant drugs, and a history of diabetes.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who fulfill the following criteria are to be included: - Despite receiving either dietary or exercise therapy or a combination of those and treatment with antidiabetic drugs*1, having uncontrolled type 2 diabetes mellitus*2 *1 sulphnoylurea agent glimepiride 0.5 mg - 2 mg, thiazolidine agents, biguanides, and alpha-glucosidase inhibitors * HbA1c (JDS value) >or= 6.5% or fasting blood glucose >or= 130 mg/dL; based on 'Treatment Guide for Diabetes 2010' by the Japan Diabetes Society. - Outpatients - Patients who have given consent for their data to be used.
Key exclusion criteria	Patients who met any of the following criteria are to be excluded: 1) Patients with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months 2) Patients who are about to have or who have undergone an operation or who have severe infections or serious injury 3) Pregnant, possibly pregnant, or lactating women 4) Patients with moderate kidney dysfunction (serum creatinine >or= 1.5 mg/dL for men, >or= 1.3 mg/dL for women ) 5) Patients who are being treated with insulin 6) Patients who are being treated with rapid acting insulin secretagogues 7) Patients with a history of hypersensitivity to ingredients of the study drug 8) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size	1400

Research contact person
Name of lead principal investigator	Yasuhiko Iwamato
Organization	Tokyo Women's Medical University
Division name	Director
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	iwamoto.yasuhiko@twmu.ac.jp

Public contact
Name of contact person	Hiroshi Sakura
Organization	Tokyo Women's Medical University
Division name	Medical Center East
Address	2-1-10 Nishi-ogu, Arakawa-ku, Tokyo
TEL	03-3810-1111
Homepage URL
Email	hsakura.dmc@twmu.ac.jp

Sponsor
Institute	Kanto Antidiabetics Study Group
Institute
Department

Funding Source
Organization	Japan Diabetes Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Women's Medial University Medical Center East, Center for Adult Diseases, Tokyo Women's Medical University, Tokyo Women's Medical University Yachiyo Medical Center, and other medical institutions.
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

ともながクリニック(東京都),板橋中央総合病院(東京都),渡辺医院(東京都),西新井病院附属成和クリニック(東京都),社団法人衛生文化協会　城西病院(東京都),手納医院(島根県),小林医院(東京都),医療法人社団誠心堂会　笠原クリニック(東京都),医療法人社団榊原厚生会　新宿三井ビルクリニック(東京都),手塚クリニック(東京都),医療法人社団桜舞会　井関内科(東京都),医療法人社団絆　アーバンハイツクリニック(東京都),木暮クリニック(東京都),あきもと佳内科クリニック(東京都),まつむら胃腸科(東京都),小山イーストクリニック(栃木県),阿部病院(東京都),関根医院(埼玉県),医療法人社団糖友会　あいそ内科(東京都),宇部内科小児科医院(東京都),宮下外科(東京都),近藤クリニック(東京都),健康館鈴木クリニック(東京都),金内メディカルクリニック(東京都),ひがみ病院(奈良県),松坂医院(東京都),加藤内科クリニック(東京都),医療法人鴻鵠会　恵比寿クリニック(東京都),小林内科クリニック(東京都),山下医院(東京都),東品川クリニック(東京都),西澤内科クリニック(東京都),伴野内科クリニック(東京都),島根大学医学部(島根県),要クリニック(東京都),西川クリニック(東京都),熊倉医院(栃木県),丸山内科医院(東京都),医療法人社団清真会　麦島内科クリニック(東京都),めじろ内科クリニック(東京都),田幡医院(東京都),社団法人至誠会第二病院(東京都),井上医院(埼玉県),社会福祉法人新栄会　滝野川病院(東京都),表参道内科眼科(東京都),東京大塚医院(東京都),土屋医院(東京都),安井医院(東京都),大西クリニック(東京都),しんクリニック(東京都),すずき内科クリニック(東京都),モモメディカルクリニック(東京都),ＪＲ東京総合病院(東京都),水野医院(東京都),にしあらい生活習慣病クリニック(東京都),西新井病院(東京都),駒崎医院(東京都),ゆうてんじ内科(東京都),上落合真クリニック(東京都),花園医院(東京都),林胃腸科外科クリニック(東京都),くにやクリニック(東京都),伊藤内科小児科医院(東京都),練馬桜台クリニック(東京都),鎮目記念クリニック(東京都),内科 小久保医院(東京都),医療法人社団 笑鯨会 なかのぶクリニック(東京都)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry	2014 Year 07 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	In Japanese patients with type 2 diabetes mellitus who had uncontrolled blood glucose, the effects of a DPP-4 inhibitor (sitagliptin) on HbA1c and other efficacy parameters as well as safety is to be prospectively investigated (observational study). In addition, after completion of the study period, subanalyses stratifying patients by factors such as complications, concomitant drugs and a history of diabetes are to be conducted to determine patients who are more likely to respond to glucose lowering therapy with sitagliptin.

Management information
Registered date	2015 Year 09 Month 29 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015843