UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012068 |
|---|---|
| Receipt number | R000014107 |
| Scientific Title | DIrect Effect of DPP-4 inhibitor on HbA1c levels and Renal Dysfunction |
| Date of disclosure of the study information | 2013/10/18 |
| Last modified on | 2018/09/18 18:07:47 |
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Basic information
Public title
DIrect Effect of DPP-4 inhibitor on
HbA1c levels and Renal Dysfunction
Acronym
DIrect Effect of DPP-4 inhibitor
and Renal Dysfunction
Scientific Title
DIrect Effect of DPP-4 inhibitor on
HbA1c levels and Renal Dysfunction
Scientific Title:Acronym
DIrect Effect of DPP-4 inhibitor
and Renal Dysfunction
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the effect on glycemic control and renal protection between two different DPP-4 inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c in 6 months
Key secondary outcomes
1) Change in physical examination(weight, BMI, blood pressure)
2) Change in glycemic control(FPG, GA)
3) Change in Insulin secretion(CPR, IRI, CPI, HOMA-beta, HOMA-R)
4) Renal function amelioration (u-albumin, eGFR, s-creatinine, Cystatin C, u- L-FABP, u-Type-IV collagen)
5) Inflammatory and oxidative stress amelioration (hs-CRP, u-8-OHdG)
6) Vascular disorder marker amelioration (sVCAM-1)
7) Change in incretin related markers(DPP-4 activity, Active GLP-1, Active GIP, Glucagon)
8) Change in serum lipid profile(T-Chol,HDL,TG,LDL)
9) Achievement rate of HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teneligliptin
Interventions/Control_2
Sitagliptin
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. Diabetes duration more than 1 year
2. Type 2 diabetes patients treated with dietand or exercise, and or SUs, and or BGs for more than 3 months
3. Diabetic nephropathy stage 2, 3
4. Age 20 - 80
5. Male and female
6. HbA1c 6.0% - 9.0%
7. No improvement of HbA1c over 0.5% in 3 months
8. Informed consent
Key exclusion criteria
1. Pregnancy
2. Patients to whom contraindications in the Package Insert apply
3. Patients whose participation in the study is judged to be difficult for reasons such as reduced ability to understand, unstable mental state, and alcoholism
4. The patients with type 1 diabetes mellitus and secondary diabetes
5. Patients treated with insulin and oral hypoglycemic agents except SUs and BGs for more than 3 months
6. Patients who have concomitant malignant tumors, or who have been treated for malignant tumors within the past 5 years
7. Foreigners, patients belonging to Kyoto University and/or Kyoto University Hospital, patients who is participating clinical trials
8. Other patients whose participation is judged to be inappropriate by the responsible physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Harashima |
Organization
Kyoto University
Division name
Diabetes, Endocrinology and Nutrition
Zip code
Address
54 Syogoin Kawaramachi Sakyo-ku Kyoto
TEL
075-751-3560
diehard@sogo-medefi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syunsuke Yamane |
Organization
Kyoto University
Division name
Diabetes, Endocrinology and Nutrition
Zip code
Address
54 Syogoin Kawaramachi Sakyo-ku Kyoto
TEL
075-751-3560
Homepage URL
diehard@sogo-medefi.jp
Sponsor or person
Institute
Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院、滋賀県立成人病センター、日本赤十字社 大津赤十字病院、高島市民病院、社会福祉法人 京都社会事業財団 京都桂病院、一般財団法人 日本バプテスト連盟医療団 日本バプテスト病院、社会福祉法人 恩賜財団 大阪府済生会 野江病院、国家公務員共済組合連合会 枚方公済病院、兵庫県立尼崎総合医療センター、公益財団法人 大原記念倉敷中央医療機構 倉敷中央病院、向ヶ丘久保田内科、公益財団法人 田附興風会 医学研究所北野病院、三菱京都病院、医療法人社団洛和会 洛和会音羽病院、とよだ医院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 18 | 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
HbA1c reduction of teneligliptin and sitagliptin in 24-weeks was -0.69% and -0.65%, respectively, with no significant difference between the two groups.
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
| 2014 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Inhibition of DPP-4 activity was stronger in teneligliptin group than that in sitagliptin group (p<0.0001).
Urinary albumin excretion was significantly decreased in the two groups.
Management information
Registered date
| 2013 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
