UMIN-CTR Clinical Trial

Public title

Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study

Acronym

Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide

Scientific Title

Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study

Scientific Title:Acronym

Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the effect of sitagliptin and nateglinide or liraglutide and exenatide on glycemic control and safety in patients with type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Standard deviation of blood glucose by CGM

Key secondary outcomes

1)averate blood glucose, MAGE by CGM
2)FPG and PPG at 1, 2, 3, 4, 5, 6, 7 days of treatment
3)%chagne of FPG, HbA1c,IRI,CPR, a from baseline

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sitagliptin 50mg for 4 months
From 2nd day of a medication start, all patients are equiped with a CGM for four days. SMBG is also done 6 times per day. If FPG is more than 130mg/dl or PPG is more than 180mg/dl, other hypoglycemic agents is consider to add. HbA1c is measured 2 or 4 months after a medical treatment start

Interventions/Control_2

nateglinide 270mg/day for 4 months

Interventions/Control_3

liraglutide0.3, 0.6, 0.9mg/day for 4 months

Interventions/Control_4

exenatide 10ug/day for 4 months

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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine (aTZD,BG,SU, alpha-GI) and inpatient
2)HbA1c (JDS):more than 6.6%, less than 16.6%
3)Type 2 diabetes
4)Pts with written IC
5)Age more than 20, less than 85

Key exclusion criteria

1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)severe hepatic dysfunction
4)or severe renal dysfunction (eGFR: more than 1.5mg/dl)
5)Patients who use of insulin
6)pregnacy
7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide
8)Patients judged by the investigator to be ineligible for some other reason

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Tadashi Yamakawa

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

yamakat@urahp.yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Erina Shigematu

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

erina-sgmt@live.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

横浜市立大学附属市民総合医療センター（神奈川県）
横須賀市立市民病院（神奈川県）

Date of disclosure of the study information

2011

Year

12

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/endocrj/63/3/63_EJ15-0500/_article

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

Completed

Date of protocol fixation

2011

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2015

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

30

Day

Last modified on

2016

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008046