UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018367 |
|---|---|
| Receipt number | R000021265 |
| Scientific Title | Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2015/07/22 |
| Last modified on | 2019/01/22 10:15:55 |
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Basic information
Public title
Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
Acronym
Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
Scientific Title
Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
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 purpose of this study is to evaluate the effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabete
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
grip strength, quadriceps muscle strength
Key secondary outcomes
abdominal fat free area and visceral fat area, Hemoglobin A1C levels, pre/postprandial blood glucose levels, BMI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sodium-dependent glucose co-transporter 2 inhibitors(SGLT2 inhibitors)
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
1) Outpatients
2) Inadequate glucose control even after dietary, exercise and drug therapies for more than 8 weeks
3) HbA1c 6.5 - 10.0%
4) Fasting blood glucose levels 110 - 250mg/dl
5) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol
Key exclusion criteria
1) Type 1 diabetes
2) Had ketosis or coma within 6 month
3) Secondary diabetes
4) Patients receiving GLP-1 analogue therapy
5) Poor-controlled diabetes (HbA1c>=10.0 % or fasting blood glucose levels>=250mg/dl)
6) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
7) Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis
8) Renal insufficiency: Ccr<45 mL/min/1.73m2
9) Patients who have serious complication of gastrointestinal disorders or who underwent a surgical operation that is known to affect the absorption of a drug by digestive tract
10) Patients who are susceptible to dehydration
11) Patients who is a chronic heavy drinker
12) Patients with history of urinary infection or genital infection disease
13) Malignancies or other diseases with poor prognosis
14) Pregnant
15) Subjects whose doctor in charge do not agree to join the trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ida |
Organization
Ise Red Cross Hospital
Division name
Department of Metabolic Diseases
Zip code
Address
471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
bboy98762006@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ida |
Organization
Ise Red Cross Hospital
Division name
Department of Metabolic Diseases
Zip code
Address
471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
Homepage URL
bboy98762006@yahoo.co.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Department of Metabolic Diseases
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
Department of Metabolic Diseases
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021265
