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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031415
Receipt No. R000035416
Scientific Title Parallel-group study comparing the effect of treatment in diabetes between insulin glargin U-300 (Lantus XR) and insulin glargin biosimillar (Insulin Glargin BS milliopen "Lily") in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2018/02/22
Last modified on 2018/02/22

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Basic information
Public title Parallel-group study comparing the effect of treatment in diabetes between insulin glargin U-300 (Lantus XR) and insulin glargin biosimillar (Insulin Glargin BS milliopen "Lily") in patients with type 2 diabetes mellitus
Acronym Parallel-group study comparing the effect of treatment in diabetes between insulin glargin U-300 and insulin glargin biosimillar in patients with type 2 diabetes mellitus
Scientific Title Parallel-group study comparing the effect of treatment in diabetes between insulin glargin U-300 (Lantus XR) and insulin glargin biosimillar (Insulin Glargin BS milliopen "Lily") in patients with type 2 diabetes mellitus
Scientific Title:Acronym Parallel-group study comparing the effect of treatment in diabetes between insulin glargin U-300 and insulin glargin biosimillar in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In type 2 diabetes patients treated with insulin glargin, insulin glargin is switched into insulin glargin U-300 or insulin glargin biosimillar, and evaluate the difference of glucose metabolism between patients treating with insulin glargin U-300 and insulin glargin biosimillar.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes In type 2 diabetes patients treated with insulin glargin, insulin glargin is switched into insulin glargin U-300 or insulin glargin biosimillar, and the difference of glucose metabolism between patients treating with insulin glargin U-300 and insulin glargin biosimillar are evaluated at 1, 2, and 3 months from baseline.
Key secondary outcomes In type 2 diabetes patients treated with insulin glargin, insulin glargin is switched into insulin glargin U-300 or insulin glargin biosimillar, and the difference of QOL, influence of hypoglycemia, lipid metabolism. blood pressure, and change of body weight between patients treating with insulin glargin U-300 and insulin glargin biosimillar are evaluated at 1,6 and 3 months from baseline.

Base
Study type Interventional

Study design
Basic design Parallel
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 Switch insulin glargin into innsulin glargin U-300 for 6 months
Interventions/Control_2 Switch insulin glargin into innsulin glargin biosimillar for 6 months
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 The inclusion criterias are shown as follows;
1.Patients aged 20 to 80 at the time of consent acquisition
2.Patient received insulin glargine for more than 1 year and performing self-blood glucose measurement as instructed by doctor.
3. Patients wiht HbA1c level ranged from 7.0% to less than 10.0%.
4.Patients who have the register's written consent of their's own free will after provided sifficient explanation and suffiency understood about this study.
Key exclusion criteria The exclusion criterias are shown as follows;
1.Patients who are a possibility of pregnancy or pregnant.
2.Patients with severe ketosis, diabetic coma or pre coma.
3.Patents with severe infections, before and after surgery or serious traumatic injury.
4.Patients undergoing blood purification therapy.
5.Patients using implantable medical devices such as pacemakers.
6.Patients receiving steroid drugs.
7.Patients with dementia.
8.Patients who are judged as inappropriae for this study by reserchers .
9.Patients who refuse to be enrolled in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Midori Yamana
Organization Nihon University Itabashi Hospital
Division name Division of Diabetes and Metabolic Diseases
Zip code
Address 30-1 Oyaguchikami-cho, Itabashi ward, Tokyo
TEL 03-3972-8111
Email ikejima-nhn@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori Yamana
Organization Nihon University Itabashi Hospital
Division name Division of Diabetes and Metabolic Diseases
Zip code
Address 30-1 Oyaguchikami-cho, Itabashi ward, Tokyo
TEL 03-3972-8111
Homepage URL
Email ikejima-nhn@umin.ac.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

Funding Source
Organization Nihon University Itabashi Hospital
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
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 02 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 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 02 Month 22 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035416

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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