UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019353 |
|---|---|
| Receipt number | R000022381 |
| Scientific Title | Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2017/02/22 16:08:50 |
* 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
Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Acronym
Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Scientific Title
Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Scientific Title:Acronym
Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety between injecting insulin glargine 300 U/ml before breakfast and injecting insulin glargine 100 U/ml before breakfast in type 2 diabetic patients treated with a basal insulin and a GLP-1 receptor agonist
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose-lowering effect evaluated with HbA1c levels after three-month treatment
Key secondary outcomes
- glucose-lowering effect evaluated with self-monitored blood glucose levels
- Subjective assessment of insulin injection
- Adverse events including hypoglycemia, weight gain, and other side effects
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
Injecting insulin glargine 100 U/ml before breakfast in period 1, and insulin glargine 300 U/ml before breakfast in period 2.
Interventions/Control_2
Injecting insulin glargine 300 U/ml before breakfast in period 1, and insulin glargine 100 U/ml before breakfast in period 2.
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
- adults with type 2 diabetes
- treated with a basal insulin
- treated with a GLP-1 receptor agonist (regardless of couse of oral hypoglycemic agents)
Key exclusion criteria
- patients injecting bolus insulin
- patients expected to have other antidiabetic agents added, changed, or increased/decreased in dosage during the next 6 months
- difficulty to perform self-monitoring blood glucose
- Patients with severe hepatic, renal, and/or cardiac disease
- Patients with hypersentitivity to the agents used in the current study
- Patients who are pregnant, breast-feeding or may become pregnant
- Patients who are judged by the investigator to be inappropriate for this study for any other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shiraiwa |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL
072-971-1221
shiraiwa@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shiraiwa |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL
072-971-1221
Homepage URL
shiraiwa@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Shiraiwa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Graduate School of Medicine
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
| 2015 | Year | 10 | Month | 14 | 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
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022381
