UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004678 |
|---|---|
| Receipt number | R000005569 |
| Scientific Title | Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2015/02/10 15:07:02 |
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Basic information
Public title
Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes
Acronym
Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes
Scientific Title
Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes
Scientific Title:Acronym
Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and the safety of DPP-4 inhibitor in type 2 diabetes mellitus inadequately controlled on intensive insulin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c level after 6 months of treatment (amount and rate of change)
Key secondary outcomes
Amount and rate of change of items and these AUC after test meal(serum glucose, CPR, intact proinsulin, glucagon, FFA, Active GLP-1, Total GIP, TG)
Amount and rate of change after 6 months of treatment(abdominal girth, daily profile of serum glucose by SMBG, Patients QOL questionnaire, Bio-markers for oxidant stress (8-isoprostane, 8-OHdG))
Amount and rate of change after 1, 2, 3, 4, 5, 6 months of treatment(Blood pressure, Body weight, HbA1c, GA, 1,5-AG, CPR, amount and frequency of insulin treatment, rate of hypoglycemic episodes)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitor with intensive insulin therapy
Interventions/Control_2
intensive insulin therapy
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
1.Outpatient
2.Patients with intensive insulin therapy
3.HbA1c =>6.5%(JDS).
4.Patients with type 2 diabetes mellitus.
5.No change in therapy with oral antidiabetes agent at least 2 months
6.Age =>20 years
7.Informed consent obtained.
Key exclusion criteria
1.Type 1 diabetes mellitus
2.Impaired renal function [serum-creatinine;
=>1.5mg/dL(male),
=>1.3mg/dL(female) or eGFR<30mL/min]
3.Severe liver dysfunction [AST, ALT=>3 fold above ULN]
4.Patients who are disqualified from the study by investigator for any reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University , School of Mecidicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo
TEL
03-5363-3797
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University , School of Mecidicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo
TEL
03-5363-3797
Homepage URL
saish@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University , School of Mecidicine, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | 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
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005569
