UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009950
Receipt number R000011615
Scientific Title Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes
Date of disclosure of the study information 2013/03/01
Last modified on 2016/02/23 10:48:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes

Acronym

SAMIT study

Scientific Title

Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes

Scientific Title:Acronym

SAMIT 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

Comparison of effect of sitagliptin and miglitol on insulin therapy in patients with type 2 diabetes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic control and glycemic excursion(variation,mean amplitude of glycemic excursion,24 hour blood glucose AUC, 1- and 2-hour postprandial glucose level by CGMS)

Key secondary outcomes

plasma glucose, serum CPR, actived GLP-1, total GIP and glucagon after diet challenge test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sitagliptin50mg/day

Interventions/Control_2

Sitagliptin50mg/day+miglitol150mg/day

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

1)Inpatients with type 2 diabetes
2)fasting plasma glucose from 80 to 140mg/dl using by insulin glargine
3)more than 2 hr postprandial glucose levels 180mg/dl
4)Age>=20

Key exclusion criteria

1)type1 diabetes, 2)severe hepatic dysfunction(AST>100mg/dl,ALT>100mg/dl), 3)severe renal dysfunction(sCr>=2.0mg/dl), 4)past history of abdominal surgery, 5)histry of anaphylaxis of DPP-4 inhibitor and arufa-glucosidase inhibitor, 6)pregnant, intention of becoming pregnant, 7)poor plasma glocose control, 8)Any other condition which the attending physician feels would interfere with the trail participation,
9)steroid treatment or steroid diabetes.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryo Kodera

Organization

Okayama University Hospital

Division name

Center for Innovative Clinical Medicine

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

086-235-6510

Email

kodera@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Kodera

Organization

Okayama University Hospital

Division name

Center for Innovative Clinical Medicine

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

086-235-6510

Homepage URL


Email

kodera@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Sanwa kagaku kenkyusho Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 03 Month 01 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

Terminated

Date of protocol fixation

2013 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2016 Year 02 Month 23 Day

Date of closure to data entry

2016 Year 02 Month 23 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 04 Day

Last modified on

2016 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011615


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name