UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014350 |
|---|---|
| Receipt number | R000016657 |
| Scientific Title | Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2016/01/27 21:10:32 |
* 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
Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy
Acronym
Adjust KOBE
Scientific Title
Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy
Scientific Title:Acronym
Adjust KOBE
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety of doctor-led titration with self titration in type 2 diabetic patients suboptimally controlled with basal supported oral therapy using insulin glargine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
indicators of glycemic control such as HbA1c and glycoalbumin
Key secondary outcomes
frequency of hypoglycemia, frequency of severe hypoglycemia, mean fasting blood glucose determined with self-monitoring blood glucose, change of insulin glargine dose, change of DTSQ score, change of weight
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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 | Maneuver |
Interventions/Control_1
In doctor-led titration group, subjects adjust insulin glargine dose according the clinical judgement of their physicians at the time of consultation one or more times in four weeks.
Physicians adjust insulin glargine dose to achive a target of fasting blood glucose level <130mg/dl.
There is no change of the timing to insulin administration, no adjustment of other hypoglycemic agent and no addition of any other drugs which effect glucose metabolism during study period.
Interventions/Control_2
In patient self titration group, Subjects adjust insulin glargine dose according the titration algorhythm directed by their physicians. The physicians check glycemic control at consultation once every four weeks.
Subjects adjust insulin glargine dose to achive a target of fasting blood glucose level <130mg/dl.
There is no change of the timing to insulin administration, no adjustment of other hypoglycemic agent and no addition of any other drugs which effect glucose metabolism during study period.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients suboptimally controlled with basal supported oral therapy using insulin glargine
HbA1c levels >=7.0% and <=11.0%
feasible to perform self-monitoring blood glucose at least once (before breakfast) daily in patients without sulfonylurea and at least twice (before breakfast and dinner) daily in patients with sulfonylurea
disease duration >=2 years
no change of oral hypoglycemic agent within preceding a month
feasible to record data from SMBG and complete questionnaires
Key exclusion criteria
diabetes other than type 2 diabetes mellitus
history of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or other severe cardiac disease within the preceding 12 months
severe renal dysfunction (serum creatinine >2.0mg/dl)
severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase >=2.5 times the normal upper limit
active proliferative diabetic retinopathy or none of ophthalmologic examination in the past 12 months
history of hypoglycemia unawareness
pregnancy or breast-feeding
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
contribution
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 18 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016657
