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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023842
Receipt No. R000027390
Scientific Title The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study.
Date of disclosure of the study information 2016/09/01
Last modified on 2019/06/27

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Basic information
Public title The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study.
Acronym The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study (HIGH-QOL study)
Scientific Title The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study.
Scientific Title:Acronym The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study (HIGH-QOL study)
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to investigate the effect of high concentration insulin glargine to the quality of life of the patients with type 2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in the pain accompanied by injection
Key secondary outcomes Change in the score regarding the easiness to use the injection device, adverse events, baseline HbA1c, age, sex, height, body weight, diabetic retinopathy, diabetic nephropathy, diabetic peripheral polyneuropathy, frequency of self monitoring of blood glucose, pharmacotherapy (insulin, other medication), place of injection.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients who use no less than 30 units of standard concentration insulin glargine (100 units/mL) per shot will be switched to high concentration insulin glargine (300 units/mL) at same dosage, except for in case there is necessity to change insulin dosage for clinical reason such as hypoglycemia prevention. In such cases, maximum plus or minus 20% change of insulin dosage is acceptable. Nanopass 34G needle is used for injection from 4 weeks prior to the replacement until the evaluation of primary endpoint and secondary endpoint.
Interventions/Control_2 Patients who use less than 30 units of standard concentration insulin glargine (100 units/mL) per shot will be switched to high concentration insulin glargine (300 units/mL) at same dosage, except for in case there is necessity to change insulin dosage for clinical reason such as hypoglycemia prevention. In such cases, maximum plus or minus 20% change of insulin dosage is acceptable. Nanopass 34G needle is used for injection from 4 weeks prior to the replacement until the evaluation of primary endpoint and secondary endpoint.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes mellitus, who are hospitalized at or regularly visit the participating hospitals/clinics, who uses standard concentration insulin glargine for no less than 4 weeks, and who provides consent to change it to high concentration insulin glargine.
Key exclusion criteria (1) Patients who already use high concentration insulin glargine.
(2) Patients who are pregnant or under preconception care.
(3) Patients to whom usage of insulin glargine is considered to be inappropriate for any reason.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Murata
Organization NHO Kyoto Medical Center
Division name Diabetes Center
Zip code 612-8555
Address 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL 075-641-9161
Email murata-tky@umin.net

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Murata
Organization NHO Kyoto Medical Center
Division name Diabetes Center
Zip code 612-8555
Address 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL 075-641-9161
Homepage URL
Email murata-tky@umin.net

Sponsor
Institute NHO Kyoto Medical Center, Diabetes Center
Institute
Department

Funding Source
Organization Sanofi K.K.
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 NHO Kyoto Medical Center, Ethics Committee
Address 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
Tel 075-641-9161
Email syomuhan@kyotolan.hosp.go.jp

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 国立病院機構京都医療センター(京都府)(NHO Kyoto Medical Center, Kyoto)、東海大学医学部付属病院(神奈川県)(Tokai University School of Medicine, Kanagawa)、国立病院機構大阪医療センター(大阪府)(NHO Osaka Medical Center, Osaka)、有澤総合病院(大阪府)(Arisawa General Hospital, Osaka)、愛生会山科病院 (京都府) (Aiseikai Yamashina Hospital, Kyoto)、大沢内科クリニック(富山県) (Osawa Clinic, Toyama)、岡山大学病院(岡山県) (Okayama University Hospital, Okayama)、神田内科クリニック(大阪府)(Kanda Clinic, Osaka)、寺沢病院(徳島県)(Terasawa Hospital, Tokushima)、総合病院土浦協同病院 (茨城県)(Tsuchiura Kyodo General Hospital, Ibaraki)、鳥取県立中央病院(鳥取県)( Tottori Prefectural Central Hospital, Tottori)、医療法人誠知会誠知クリニック(神奈川県)(Seichi Clinic, Kanagawa)、澤木内科・糖尿病クリニック(大阪府)(Sawaki Internal Medicine and Diabetes Clinic, Osaka)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_1794-18/_article
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_1794-18/_article
Number of participants that the trial has enrolled 108
Results
The improvement in the pain score was not significant for >=30 units compared with <30units (-50.3, SD 24.0 vs. -40.4, SD 28.5, p = 0.25), but a significant difference was observed for >=20 units compared with <20 units (-50.8, SD 22.7 vs. -38.4, SD 29.1, p = 0.03, as well as for  >=10 units compared with <10 units (-48.1, SD 25.0 vs. -33.0, SD 29.7, p < 0.01). When all participants were analyzed together, significant improvements in the pain score (-41.5, SD 28.0, p <0.01) was observed.
Results date posted
2019 Year 06 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 06 Month 27 Day
Baseline Characteristics
Average age 65.0 years old.
Participant flow
Not available.
Adverse events
Not available.
Outcome measures
Pain score.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 12 Day
Date of IRB
2016 Year 05 Month 16 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 20 Day
Date trial data considered complete
2017 Year 09 Month 20 Day
Date analysis concluded
2019 Year 03 Month 24 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027390

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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