UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031415 |
|---|---|
| Receipt number | 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 | 2020/08/26 14:30:54 |
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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
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
ikejima-nhn@umin.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 26 | Day |
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
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035416
