UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010157 |
|---|---|
| Receipt number | R000011893 |
| Scientific Title | Efficacy and safety of sitagliptin as add-on therapy to multiple daily insulin injections therapy in inadequately controlled Japanese subjects with type 2 diabetes |
| Date of disclosure of the study information | 2013/03/11 |
| Last modified on | 2019/09/08 16:08:12 |
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Basic information
Public title
Efficacy and safety of sitagliptin as add-on therapy to multiple daily insulin injections therapy in inadequately controlled Japanese subjects with type 2 diabetes
Acronym
Combination therapy with MDI and DPP4i
Scientific Title
Efficacy and safety of sitagliptin as add-on therapy to multiple daily insulin injections therapy in inadequately controlled Japanese subjects with type 2 diabetes
Scientific Title:Acronym
Combination therapy with MDI and DPP4i
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of adding sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in subjects with type 2 diabetes inadequately controlled with multiple daily insulin injections therapy (MDI). HbA1c, 1,5-anhydroglucitol (1,5-AG), body mass index (BMI), insulin doses, were assessed before, after 12 weeks, and after 24 weeks of treatment with 50 mg/day of sitagliptin in subjects with type 2 diabetes. Safety endpoints included hypoglycemia and adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, hypoglycemia
Key secondary outcomes
1,5-anhydroglucitol (1,5-AG), body mass index (BMI), insulin doses, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50mg/day sitagliptin
24 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes treated with MDI at dose of at least 10 units/day and for at least 12 months
HbA1c>6.9%
Key exclusion criteria
type 1 diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Shimoda |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
8608556
Address
1-1-1 Honjo Chuo-Ku, Kumamoto, Kumamoto 860-8556, Japan
TEL
096-373-5169
sshimoda@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Shimoda |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
860-8556
Address
1-1-1 Honjo Chuo-Ku, Kumamoto, Kumamoto 860-8556, Japan
TEL
096-373-5169
Homepage URL
sshimoda@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
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
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo Chuo-Ku, Kumamoto, Kumamoto 860-8556, Japan
Tel
096-344-2111
sshimoda@gpo.kumamoto-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ13-0198/_article/-char/ja/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ13-0198/_article/-char/ja/
Number of participants that the trial has enrolled
40
Results
HbA1c significantly decreased during the first 12 weeks (-0.64 %), and was sustained over 24 weeks (-0.69 %). 1,5-AG increased significantly from 7.5 microg/mL at baseline to 9.6 microg/mL after 24 weeks.
Results date posted
| 2019 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
subjects were type 2 diabetes treated with MDI
Participant flow
All 40 subjects completed the trial
Adverse events
Hypoglycemia was experienced by 40 % of subjects in this study
Outcome measures
The changes from baseline in HbA1c and 1,5-AG during the 24 weeks of treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011893
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| Registered date | File name |
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