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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014350
Receipt No. 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

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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
Email 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
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016657

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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