UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025952
Receipt No. R000029835
Scientific Title Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Date of disclosure of the study information 2017/02/01
Last modified on 2018/05/18

* 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 Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Acronym Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Scientific Title Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Scientific Title:Acronym Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Region
Japan

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

Objectives
Narrative objectives1 To investigate which is the best long-acting insulin to reduce hypoclycemia, Insulin glargine 300 U/ml, Insulin degludec or Insulin glargine 100 U/ml .
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AOC (<70 mg/dL) for glycemic variability (0:00-6:00, 8:00-24:00, 24:00)
Key secondary outcomes 00:00 to 6:00 percentage of time in hypoglycemic range (<54 mg/dL)
mean absolute glucose (MAG)
glycemic variability percentage (GVP)
mean glucose level (0:00-6:00, 24:00)
SD (0:00-6:00, 24:00)
coefficient of variation (CV) (0:00-6:00, 24:00)
M-value (0:00-6:00, 24:00)
MAGE
MODD
ADRR
low blood glucose index (LBGI)

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FreeStyle Libre Pro is worn after admission. Insulin glargine 300 U/ml are evaluated on day 3 and day 4. Then, Insulin degludec are evaluated on day 8 and day 9. Then, Insulin glargine 100 U/ml are evaluated on day 13 and day 14.
Interventions/Control_2 FreeStyle Libre Pro is worn after admission. Insulin degludec are evaluated on day 3 and day 4. Then, Insulin glargine 100 U/ml are evaluated on day 8 and day 9. Then, Insulin glargine 300 U/ml are evaluated on day 13 and day 14.
Interventions/Control_3 FreeStyle Libre Pro is worn after admission. Insulin glargine 100 U/ml are evaluated on day 3 and day 4. Then, Insulin glargine 300 U/ml are evaluated on day 8 and day 9. Then, Insulin degludec are evaluated on day 13 and day 14.
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 medicated long-acting insulin 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
Name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization General Inuyamachuo Hospital
Division name Department of Diabetes
Zip code
Address 6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization General Inuyamachuo Hospital
Division name Department of Diabetes
Zip code
Address 6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute General Inuyamachuo Hospital
Institute
Department

Funding Source
Organization General Inuyamachuo 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
2017 Year 02 Month 01 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
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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
2017 Year 02 Month 01 Day
Last modified on
2018 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.