UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022239 |
|---|---|
| Receipt number | R000025616 |
| Scientific Title | Efficacy and safety of thrice-weekly insulin degludec in elderly patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/05/08 |
| Last modified on | 2018/07/18 12:44:13 |
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Basic information
Public title
Efficacy and safety of thrice-weekly insulin degludec in elderly patients with type 2 diabetes
Acronym
Thrice-weekly insulin degludec regimen
Scientific Title
Efficacy and safety of thrice-weekly insulin degludec in elderly patients with type 2 diabetes
Scientific Title:Acronym
Thrice-weekly insulin degludec regimen
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the efficacy and safety of thrice-weekly insulin degludec (IDeg) therapy in elderly patients with type 2 diabetes who need insulin therapy but cannot perform self-injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic controlassessed by continuous glucose monitoring over 7 days
Key secondary outcomes
The percent duration of hypo- (<70 mg/dL and hyper- (>200 mg/dL) glycemia
Base
Study type
Interventional
Study design
Basic design
Parallel
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
After becoming stable on once-daily insulin degludec treatment, OD group was assigned to continue once-daily injection.
Interventions/Control_2
After becoming stable on once-daily insulin degludec treatment, TW group was switched to thrice-weekly injection.
IDeg was injected at twice the OD dose before lunch on Monday, Wednesday, and Friday.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were the following relative indications for insulin treatment according to the Japan Diabetes Society: 1) detection of marked hyperglycemia (e.g., fasting plasma glucose > 250 mg/dL or casual plasma glucose > 350 mg/dL) in the non-insulin-dependent state, 2) failure to achieve good glycemic control with oral hypoglycemic agents, 3) deterioration of the nutritional status in a lean patient, or 4) to achieve active control of glucose toxicity when this is needed.
Key exclusion criteria
The exclusion criteria were the following absolute indications for insulin treatment: 1) an insulin-dependent state, 2) diabetic coma, 3) hyperglycemia complicated by severe liver or kidney disease, 4) serious infection, trauma, or major surgery, 5) intravenous alimentation. Patients who had no difficulty performing self-injection of insulin were also excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
0449778111
smu.tainai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Nagai |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
0449778111
Homepage URL
ynagai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School ofMedicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/63/12/63_EJ16-0252/_article
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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 18 | 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
| 2016 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025616
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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