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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012068
Receipt No. 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

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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
Email 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
Email diehard@sogo-medefi.jp

Sponsor
Institute Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University
Institute
Department

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
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 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
URL(English) https://upload.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


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