UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	DIrect Effect of DPP-4 inhibitor on HbA1c levels and Renal Dysfunction
Title of the study (Brief title)	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	Shinichi Harashima
Organization	Kyoto University
Division name	Diabetes, Endocrinology and Nutrition
Address	54 Syogoin Kawaramachi Sakyo-ku Kyoto
TEL	075-751-3560
Email	diehard@sogo-medefi.jp

Public contact
Name of contact person	Syunsuke Yamane
Organization	Kyoto University
Division name	Diabetes, Endocrinology and Nutrition
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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