UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013285 |
|---|---|
| Receipt number | R000015395 |
| Scientific Title | Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring. |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/05/29 09:40:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Acronym
Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Scientific Title
Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Scientific Title:Acronym
Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Region
| Japan |
Condition
Condition
type 1 diabetes or type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the glucose-lowering effect and glycemic variability of insulin glargine with those of insulin degludec using continuous glucose monitoring (CGM).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0 mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10). The AUC is calculated using the trapezoidal method.
Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE).
Day-to-day glycemic variability is assessed as the mean of daily difference (MODD).
Hypoglycemia, which is defined as a sensor value of <3.9 mmol/L, was also calculated as a total time at <3.9 mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8 mmol/L.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-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
The patient's prior long-acting insulin analog is discontinued and replaced with insulin glargine. The CGM examination is carried out at least 14 days after switching insulin. Insulin glargine is changed to insulin degludec when the first CGM examination end. Basically, the dose of insulin degludec is the same as that of insulin glargine.
Interventions/Control_2
The patient's prior long-acting insulin analog is discontinued and replaced with insulin degludec. The CGM examination is carried out at least 14 days after switching insulin. Insulin degludec is changed to insulin glargine when the first CGM examination end. Basically, the dose of insulin glargine is the same as that of insulin degludec.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetic patients who were prescribed basal-bolus insulin therapy with long-acting insulin analog as basal insulin.
Key exclusion criteria
Patients with diabetic nephropathy more than stage 3 (urinary albumin 300mg/gCr or urinary protein 0.5g/gCr) or with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamada Satoru |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabetes Center
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inoue Gaku |
Organization
Kitasato University School of Pharmacy
Division name
Center for Clinical Pharmacy and Clinical Sciences
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6359
Homepage URL
inoueg@pharm.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Pharmacy
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
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://journals.sagepub.com/doi/10.1177/1932296814564396
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
| 2013 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015395
