UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004970 |
|---|---|
| Receipt number | R000005911 |
| Scientific Title | Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea. |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2014/10/23 15:39:44 |
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Basic information
Public title
Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea.
Acronym
Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea.
Scientific Title
Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea.
Scientific Title:Acronym
Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of once daily administration of 0.9mg liraglutide and once daily administration of 50~100mg sitagliptin as assessed by HbA1c after 24 weeks in patients with type 2 diabetes using high-dose sulfonylurea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c level after 24 weeks of treatment
Key secondary outcomes
Fasting plasma glucose
Percentage of patients achieving HbA1c target <6.5% or =<7.0%(JDS)
Weight
Beta-cell function (HOMA-beta, proinsulin/insulin ratio, proinsulin/C-peptide ratio)
Bio-markers for cardiovascular effects (NT-proBNP, hsCPR)
Blood pressure
Rate of hypoglycaemic episodes
Adverse events
Patients questionnaire (PAID)
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
24-week treatment of liraglutide in combination with SU
Interventions/Control_2
24-week treatment of sitagliptin in combination with SU
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes mellitus (Age >=18 years, <80 years).
2. Patients able to come to hospital/clinic every bi-week.
3. Patients on monotherapy of sulfonylurea* or combination therapy of sulfonylurea with other one or two OAD for no less than 8 weeks. (*sulfonylurea: glimepilide 2~6mg, glibenclamide 2.5~10mg, gliclazide 80~160mg)
4. HbA1c >=6.5%, <=9.0%(JDS).
5. BMI <=35kg/m2.
6. Informed consent obtained
Key exclusion criteria
1. Known hypoglycemia unawareness or recurrent major hypoglycemia.
2. Patients with proliferative retinopathy or maculopathy requiring acute treatment
3. Impaired hepatic function [GOT(AST)>80IU/L or GPT(ALT)>80IU/L], Impaired renal function (serum-creatinine; >=1.7mg/dL)
4. Patients with allergic reaction to the trial products or related products
5. Patients with known or previous malignant tumour and are strongly suspected of recurrence
6. Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant
7. The receipt of any investigational drug within 12 weeks prior to this trial
8. Previous treatment with liraglutide or sitagliptin
9. The receipt of insulin within 12 weeks prior to this trial (however, a temporary use of no more than 7 days in total within 12 weeks is permitted)
10. Current treatment or expected to start treatment with systemic corticosteroids
11. Any other condition which the attending physician feels would interfere with the trial participation.
Target sample size
152
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yokoyama |
Organization
Jiyugaoka Medical Clinic
Division name
Internal Medicine
Zip code
Address
West 6, South 6-4-3, Obihiro, 080-0016, Hokkaido, Japan
TEL
0155-20-5011
dryokoyama@yokoyamanaika.sakura.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Yokoyama |
Organization
Jiyugaoka Medical Clinic
Division name
Internal Medicine
Zip code
Address
West 6, South 6-4-3, Obihiro, 080-0016, Hokkaido, Japan
TEL
0155-20-5011
Homepage URL
dryokoyama@yokoyamanaika.sakura.ne.jp
Sponsor or person
Institute
Japan Diabetes Clinical Data Management Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
横山内科クリニック（北海道）、前原医院（千葉県）、湯原内科医院（岡山県）、岩崎内科医院（山口県）、自由が丘山田内科（北海道）、HECサイエンスクリニック（神奈川県）、高井内科クリニック（神奈川県）、りい内科クリニック（福岡県）、杉本クリニック（福岡県）、三咲内科クリニック（千葉県）、千葉中央メディカルセンター（千葉県）、川井クリニック（茨城県）、大石内科クリニック（京都府）、田中内科クリニック（福岡県）、多摩センタークリニックみらい（東京都）、屋宜内科（沖縄県）、みやざわ循環器内科クリニック（北海道）、さつき内科クリニック（埼玉県）、工藤内科クリニック（青森県）、せいの内科クリニック（福島県）、ふじた医院（岡山県）、髙木内科クリニック（新潟県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/?cmd=HistorySearch&querykey=3
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 | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005911
