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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021944
Receipt No. R000025299
Scientific Title The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study)
Date of disclosure of the study information 2016/04/26
Last modified on 2016/04/17

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Basic information
Public title The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study)
Acronym The efficacy of linagliptin and dulaglutide in hemodialysis patients with type 2 diabetes mellitus
Scientific Title The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study)
Scientific Title:Acronym The efficacy of linagliptin and dulaglutide in hemodialysis patients with type 2 diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of lingaliptin and once-weekly dulaglutide on glycemic control and safety 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 The amount changes of glycoalbuin and hemoglobin A1c for 26 weeks
The amount changes of daily use insulin in the patients who treated with insulin for 26 weeks
Key secondary outcomes The amount changes of glycoalbuin and hemoglobin A1c for 12 weeks
The amount changes of average body weight before dialysis for one week, self monitoring blood glucose, plasma glucose before hemodialysis, UA, TG, HDL-Cho, LDL-Cho, C-peptide, adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The target patients switch from linagliptin to once-weekly 0.75mg dulaglutide. We follow it up for 26 weeks. In the patient using insulin with hypoglycemic risk, insulin dose was adjusted once or twice weekly.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Type 2 diabetes patients who passed more than three months after the dialysis introduction.
2)The patients with linagliptin who satisfy more than 7.0% HbA1c or more than 20.0% glycoalbumin.
3)BMI is more than 22.0kg/m2
Key exclusion criteria 1)Patients with severe gastroparesis
2)The patient with the medical history of the pancreatitis
3)Patients who have a medical history of hypersensitivity
4)Pregnant or possibly pregnant women and women on lactation
5)Ineligible patients according to the investigator&#39;s judgment
6)The patients who do not agree with this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Ogawa
Organization Tokyo Women`s Medical University Medical Center East
Division name Internal Medicine
Zip code
Address 2-1-10 Nishiogu Arakawa-ku Tokyo 116-8567 Japan
TEL 03-3810-1111
Email tetsu07jp@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuri Yamashita
Organization Tokyo Women`s Medical University Medical Center East
Division name Internal Medicine
Zip code
Address 2-1-10 Nishiogu Arakawa-ku Tokyo 116-8567 Japan
TEL 03-3810-1111
Homepage URL
Email tetsuri218@yahoo.co.jp

Sponsor
Institute Minamisenju Hospital
Institute
Department

Funding Source
Organization Minamisenju Hospital
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 南千住病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 26 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 17 Day
Last modified on
2016 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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