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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024284
Receipt No. R000027975
Scientific Title A non-inferiority trial about the efficacy, safety, and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by the comparison with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Date of disclosure of the study information 2016/10/11
Last modified on 2019/03/31

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Basic information
Public title A non-inferiority trial about the efficacy, safety, and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by the comparison with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Acronym A non-inferiority trial about the efficacy, safety, and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by the comparison with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Scientific Title A non-inferiority trial about the efficacy, safety, and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by the comparison with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Scientific Title:Acronym A non-inferiority trial about the efficacy, safety, and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by the comparison with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Region
Japan

Condition
Condition End-stage renal disease caused by type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy, safety and effect on QOL of weekly-DPP-4 inhibitor omarigliptin by comparing with once-daily-DPP-4 inhibitor linagliptin in maintenance hemodialysis patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change in glycoalbumin (GA) and HbA1c.
Key secondary outcomes Secondary outcomes
1. The change in the scores of Development and Psychometric Validation of the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire.
2. The change in body composition evaluated by using InBody.
3. The change of blood glucose, GLP-1, GIP, and glucagon during hemodialysis treatment.
4. The change in the interdialytic weight gain rate.

Safety outcomes
1. Frequency of serious adverse events associated with the use of omarigliptin.
2. Frequency of hypoglycemia events associated with the use of omarigliptin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once-weekly oral administration of omarigliptin (12.5mg) for 6 months.
Interventions/Control_2 Once-daily oral administration of linagliptin (5mg) for 6 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those undergoing maintenance hemodialysis for more than 6 months.
2. Those aged 20 or over, with type 2 diabetes treated with DPP-4 inhibitors for more than 3 months.
3. Those who have given written informed consent on the use of their clinical data for this trial.
Key exclusion criteria 1. Those undergoing maintenance hemodialysis for more than 6 months.
2. Those aged 20 or over, with type 2 diabetes treated with DPP-4 inhibitors for more than 3 months.
3. Those who have given written informed consent on the use of their clinical data for this trial.
1. Those who have been treated with GLP-1 receptor agonists.
2. Those with hypersensitivity to DPP-4 inhibitors or GLP-1 receptor agonists.
3. Those with serious diabetic ketosis, coma, or pre-coma.
4. Those with severe active infection, serious trauma, or in the perioperative period.
5. Those with severe heart or liver dysfunction
6. Those with problems shown as below:
1) Pituitary gland or adrenal gland dysfunction
2) In the status of impaired nutrition, starvation, irregular or insufficient dietary intake, or hyposthenia.
3) Excessive muscular exercise
4) Heavy alcohol drinkers.
7. Those who are pregnant or beast-feeding, or those who might be pregnant
8. Those with uncontrolled hyper glycaemia (GA >=27% or HbA1c >=9%), on their current treatment with the oral medicine.
9. Those who are considered not eligible for this trial by attending doctors due to any medical reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akihiko
Middle name
Last name Saito
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Applied Molecular Medicine
Zip code 951-8520
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL 025-227-0915
Email akisaito@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Michihiro
Middle name
Last name Hosojima
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Clinical Nutrition Science
Zip code 951-8520
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL 025-368-9312
Homepage URL
Email hoso9582@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Department of Applied Molecular Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shinrakuen Hospital
Nagaoka Red Cross Hospital
Nagaoka Chuo General Hospital
Sado General Hospital
Kido Hospital
Niigata Saiseikai Sanjo Hospital
Koyo Medical Clinic
Maihira Clinic
University of Niigata Prefecture
Gunma University
Name of secondary funder(s)

IRB Contact (For public release)
Organization The institutional review boards of Niigata University
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
Tel 025-227-2006
Email shomu@med.niigata-u.ac.jp

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 新潟大学医歯学総合病院(新潟県)、信楽園病院(新潟県)、長岡赤十字病院(新潟県)、長岡中央総合病院(新潟県)、佐渡総合病院(新潟県)、木戸病院(新潟県)、
新潟県済生会三条病院(新潟県)、向陽メディカルクリニック(新潟県)、舞平クリニック(新潟県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 11 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 33
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
2016 Year 09 Month 02 Day
Date of IRB
2016 Year 08 Month 22 Day
Anticipated trial start date
2016 Year 10 Month 11 Day
Last follow-up date
2019 Year 03 Month 10 Day
Date of closure to data entry
2019 Year 03 Month 10 Day
Date trial data considered complete
2019 Year 03 Month 23 Day
Date analysis concluded
2019 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027975

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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