UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Title of the study (Brief title)	Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the clinical effects and the underlying mechanisms of novel anti-diabetic combination drug (teneligliptin + canagliflozin).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic control assessed by meal tolerance test and continuous glucose monitoring on each treatment period
Key secondary outcomes	1) Insulin secretion capacity and pattern 2) Incretin (GLP-1, GIP) secretion capacity and pattern 3) Glucagon secretion capacity and pattern 4) Ghrelin secretion capacity and pattern 5) Des-acyl ghrelin secretion capacity and pattern 6) C peptide secretion capacity and pattern 7) Changes in urine volume, urinary C peptide, urinary protein, and urinary glucose 8) Changes in body weight, body composition, blood pressure, and pulse rate 9) Changes in renal function, liver function, uric acid, serum lipid, keton body, HOMA-R, and HOMA-beta

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Under hospitalized for 2 weeks, patients will be orally administered Tenellia 20 mg/day from day 4 to day 10. Then, patients will be taken Canalia 1 tablet/day from day 11 to day 14.
Interventions/Control_2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients aged 20 to 75 years old with type 2 diabetes. HbA1c: 7~10% with no medication or only metformin.
Key exclusion criteria	1. Patient who cannnot regulary visit hospital 2. Patient with advanced diabetic retinopathy 3. Dialysis patient with diabetes 4. Patient who judged inappropriate due to the complications and treatment by attending doctor
Target sample size	15

Research contact person
Name of lead principal investigator	Hiroaki Ueno
Organization	University of Miyazaki , fuculty of medicine
Division name	Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan
TEL	0985-85-2965
Email	intron@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Hiroaki Ueno
Organization	University of Miyazaki , fuculty of medicine
Division name	Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
Address	5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-2965
Homepage URL
Email	intron@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki , fuculty of medicine, Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
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	宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 06 Day
Anticipated trial start date	2018 Year 03 Month 28 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry	2019 Year 03 Month 29 Day
Date trial data considered complete	2019 Year 03 Month 29 Day
Date analysis concluded	2019 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 20 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033260