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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004970
Receipt No. 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

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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
Email 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
Email dryokoyama@yokoyamanaika.sakura.ne.jp

Sponsor
Institute Japan Diabetes Clinical Data Management Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005911

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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