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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032856
Receipt No. R000037467
Scientific Title Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Date of disclosure of the study information 2018/06/04
Last modified on 2018/12/01

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Basic information
Public title Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Acronym Glycemic variability from switching to steady state in patients treated with long-acting insulin
Scientific Title Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Scientific Title:Acronym Glycemic variability from switching to steady state in patients treated with long-acting insulin
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the glycemic variability from switching to steady state in patients treated with long-acting insulin (insulin glargine 300 U/ml, next, insulin degludec or insulin degludec, next, insulin glargine 300 U/ml).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean of daily difference 1 (MODD1)
Key secondary outcomes Multiple continuous overlapping net glycemic action 24 (MCONGA24) (original index)
Standard deviation of daily difference (SDODD) (original index)
Mean of daily difference (MODD) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day)
continuous overlapping net glycemic action 24 (CONGA24) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day)
Mean absolute glucose (MAG) during evaluation duration (for 7 days)
Glycemic variability percentage (GVP) during evaluation duration (for 7 days)
Mean glucose level during evaluation duration (for 7 days)
Standard deviation (SD) during evaluation duration (for 7 days)
Coefficient of variation (CV) during evaluation duration (for 7 days)

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 Upon admission, insulin glargine 300 U/ml is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin glargine 300 U/ml. Insulin glargine 300 U/ml is switched to insulin degludec on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin degludec is switched to insulin glargine 300 U/ml on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
Interventions/Control_2 Upon admission, insulin degludec is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin degludec. Insulin degludec is switched to insulin glargine 300 U/ml on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin glargine 300 U/ml is switched to insulin degludec on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetic patients treated with long-acting insulin in basal insulin therapy for 3 month or longer
Key exclusion criteria severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
judged to be unsuitable for participation for medical reasons
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization Inuyama Chuo General Hospital
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
Email

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
2018 Year 06 Month 04 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 06 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 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
2018 Year 06 Month 04 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037467

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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