UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010703
Receipt number R000012509
Scientific Title The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/05/13
Last modified on 2019/10/16 15:52:31

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Basic information

Public title

The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus

Acronym

The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus

Scientific Title

The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus

Scientific Title:Acronym

The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus

Region

Japan


Condition

Condition

type 2 diabetes mellitus undergoing hemodialysis

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total daily dose of insulin and HbA1c(NGSP) at 0, 12 and 24 weeks after administration of vildagliptin
Mean amplitude of glycemic excursions
Safety and adherence

Key secondary outcomes

Events of hypoglycemia
Body weight


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient who have poor glycemic control undergoing insulin therapy or judged that it was expectable to reduce the insulin dose in addition to vildagliptin
2)CPI<0.8

Key exclusion criteria

1) Severe ketosis, or diabetic coma or precoma, type1 diabetes
2) Severe liver dysfunction
3) Diarrhea or vomiting
4) Severe infection, before and after surgery, or severe trauma
5) History of lactic acidosis or pancreatitis
6) Severe cardiac or pulmonary dysfunction, such as shock, heart failure, myocardial infarction, and pulmonary embolism.
7) Dehydration
8) History of severe alcoholic abuse
9) Malnutrition, starvation, debility, pituitary dysfunction, and adrenal insufficiency
10) Pregnant female, female with possibility of pregnancy
11) Malignancy
12) History of hypersensitivity to targeted medication
13) Patients inappropriate for medical reason

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuaki Soejima

Organization

Saiseikai Kumamoto Hospital

Division name

Kidney and Urology center

Zip code


Address

5-3-1 Chikami Minami-ku Kumamoto

TEL

096-351-8000

Email

kazuaki-soejima@saiseikaikumamoto.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Inoue

Organization

Saiseikai Kumamoto Hospital

Division name

Kidney and Urology center

Zip code


Address

5-3-1 Chikami Minami-ku Kumamoto

TEL

096-351-8000

Homepage URL


Email

hironobu-inoue@saiseiakikumamoto.jp


Sponsor or person

Institute

Saiseikai Kumamoto Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

済生会熊本病院


Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 13 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2013 Year 05 Month 01 Day

Date of IRB

2013 Year 05 Month 13 Day

Anticipated trial start date

2013 Year 05 Month 13 Day

Last follow-up date

2014 Year 05 Month 13 Day

Date of closure to data entry

2014 Year 05 Month 13 Day

Date trial data considered complete

2014 Year 05 Month 13 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information

The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.


Management information

Registered date

2013 Year 05 Month 13 Day

Last modified on

2019 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name