UMIN-CTR Clinical Trial

Public title

Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus

Acronym

Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus (JAMP study)

Scientific Title

Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus

Scientific Title:Acronym

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

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiko Iwamato

Organization

Tokyo Women's Medical University

Division name

Director

Zip code

Address

8-1 Kawadacho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

iwamoto.yasuhiko@twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Sakura

Organization

Tokyo Women's Medical University

Division name

Medical Center East

Zip code

Address

2-1-10 Nishi-ogu, Arakawa-ku, Tokyo

TEL

03-3810-1111

Homepage URL

Email

hsakura.dmc@twmu.ac.jp

Institute

Kanto Antidiabetics Study Group

Institute

Department

Personal name

Organization

Japan Diabetes Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2015

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

Date of protocol fixation

2010

Year

04

Month

01

Day

Date of IRB

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

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.

Registered date

2015

Year

09

Month

29

Day

Last modified on

2017

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015843