UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030043 |
|---|---|
| Receipt number | R000033260 |
| Scientific Title | Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor |
| Date of disclosure of the study information | 2018/02/06 |
| Last modified on | 2019/01/28 13:00:51 |
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Basic information
Public title
Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Acronym
Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Scientific Title
Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
University of Miyazaki , fuculty of medicine
Division name
Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan
TEL
0985-85-2965
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
University of Miyazaki , fuculty of medicine
Division name
Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
Zip code
Address
5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-2965
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki , fuculty of medicine, Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine
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
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 |
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
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
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033260
