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

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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 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


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

Value
https://center6.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