UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024284 |
|---|---|
| Receipt number | 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 09:48:45 |
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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
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
hoso9582@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Department of Applied Molecular Medicine
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027975
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