UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016969 |
|---|---|
| Receipt number | R000018400 |
| Scientific Title | The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study) |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2018/08/31 18:16:04 |
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Basic information
Public title
The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study)
Acronym
Add Tofogliflozin to Oral anti-diabetic Medicine and once-daily Injection Combo (ATOMIC) Study
Scientific Title
The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study)
Scientific Title:Acronym
Add Tofogliflozin to Oral anti-diabetic Medicine and once-daily Injection Combo (ATOMIC) Study
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For type 2 diabetes patients controlled inadequately with HbA1c 7.0 to 10.0%, taking oral anti-diabetic drugs including the DPP-4 inhibitors in addition to diet and exercise therapy for 12 weeks or more, to perform switching to human GLP-1 analog liraglutide or adding on long-acting insulin glargine once daily.
It is intended to be compared the incidence of adverse events such as hypoglycemia and usefulness in glycemic control between two groups in multicenter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. difference of glucose improvement by taking Tofo or not
2. difference of glucose improvement by the injection method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Until December 2016.
Assign randomly to a group adding Tofogliflozin and a group not to add for each 3 months.
The subcutaneous injection once a day both groups. For glargine group, the attending physician dose adjusted according to the algorithm.
Interventions/Control_2
Group1:withTofo-WashOutPeriod-without
Group2:without -WashOutPeriod-withTofo
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
(1) Patients with HbA1c 7.0 to 10%
(2) Patients who are registered in the clinical trial (UMIN000012224)
(3) Adalts who are 20 years or older
(4) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria
(1) Type 1 diabetes mellitus patients
(2) Patients with severe liver disease
(3) Patients with severe renal disease
(4) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(5) Patients with severe pancreas disease
(6) Patients having a cancer
(7) Patients with hemoglobin (Hb) less than 11 g/dL
(8) Patients that the number of the platelets is less than 100,000 /mm3
(9) Patients with high diabetic neuropathy
(10) Patients having a proliferative retinopathy
(11) Patients with a serious infectious disease or a serious injury
(12) Patients with bowel disease or ileus factors
(13) Chronic enteropathy patients with the digestion and absorption abnormality
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant
(16) Patients who was infected with hepatitis B virus or hepatitis C virus
(17) In addition, the patient who judged inappropriate by an attendant physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Miyagi |
Organization
Toho University School of Medicine
Division name
Division of diabetes, metabolism and endocrinology
Zip code
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
miyagi-m@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Miyagi |
Organization
Toho University School of Medicine
Division name
Division of diabetes, metabolism and endocrinology
Zip code
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
miyagi-m@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
大森赤十字病院内科（東京都），済生会横浜市東部病院糖尿病内分泌内科（神奈川県），ささもとクリニック（東京都），しんクリニック（東京都），徳島県立中央病院糖尿病・代謝内科（徳島県），徳島大学糖尿病臨床・研究開発センター（徳島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | 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
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis in
Management information
Registered date
| 2015 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018400
