UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012138 |
|---|---|
| Receipt number | R000014196 |
| Scientific Title | Comparison study between insulin glargine and decludec on the glucose fluctuation in Type 2 diabetic patients treated with basal insulin and oral hypoglycemic agents. |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2013/10/28 12:24:34 |
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Basic information
Public title
Comparison study between insulin glargine and decludec on the glucose fluctuation in Type 2 diabetic patients treated with basal insulin and oral hypoglycemic agents.
Acronym
Comparison study between insulin glargine and decludec on the glucose fluctuation
Scientific Title
Comparison study between insulin glargine and decludec on the glucose fluctuation in Type 2 diabetic patients treated with basal insulin and oral hypoglycemic agents.
Scientific Title:Acronym
Comparison study between insulin glargine and decludec on the glucose fluctuation
Region
| Japan |
Condition
Condition
Type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficacy of insulin glargine and decludec on the glucose fluctuation by using CGM and Endopat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGM(glucose average, SD, MAGE) and Endo-pat
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
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
insulin glargine
Interventions/Control_2
insulin decludec
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
T2 MD treated with insulin glargine and oral hypoglycemic agents(HbA1c; over than 6.5%)
Key exclusion criteria
patients with liver or renal dysfunction and obese patienst(BMI over than 35)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Sumitani |
Organization
Kyorin University of Medicine
Division name
Third Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
042-247-5512
sumitani@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Sumitani |
Organization
Kyorin University of Medicine
Division name
Third Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
024-247-5512
Homepage URL
sumitani@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin university of Medicine, Third Department of Internal Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 10 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | 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
| 2013 | Year | 10 | Month | 28 | Day |
Last modified on
| 2013 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014196
