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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004243
Receipt No. R000005087
Scientific Title Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial
Date of disclosure of the study information 2010/10/01
Last modified on 2015/10/11

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Basic information
Public title Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial
Acronym Keio study for INitial treatment of type 2 Diabetes with Liraglutide versus Metformin: KIND-LM study
Scientific Title Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial
Scientific Title:Acronym Keio study for INitial treatment of type 2 Diabetes with Liraglutide versus Metformin: KIND-LM study
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 and the safety of liraglutide and high-dose metformin in over-weight patients type 2 diabetes mellitus treated with monotherapy or combination therapy by alpha-glucosidase inhibitor and/or biganide
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 Percentage of patients achieving HbA1c target <6.5% or 7.0%(JDS)
Fasting plasma glucose
Body weight
Rate of hypoglycaemic episodes
Beta-cell function (HOMA-beta, proinsulin/insulin ratio)
Bio-markers for cardiovascular effects (PAI-1, hsCPR, BNP)
Bio-markers for oxidative stress (8-OH-dG, 8-isoprostane)
Patients QOL questionnaire

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 monotherapy
Interventions/Control_2 24-week treatment of high-dose metformin monotherapy
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes mellitus.
2. Informed consent obtained.
3. Age >=20 years, <75 years
4. Patients on diet/exercise therapy with or without OAD* monotherapy or combination therapy for no less than 3 months. (*OAD: alpha-glucosidase inhibitor or biganide)
5. Patients diagnosed as type 2 diabetes mellitus in ten years.
6. HbA1c >=6.5%, <9.0%(JDS).
7. BMI >=23.5kg/m2.
8. Patients able to come to hospital/clinic every bi-week.
Key exclusion criteria 1. Type 1 diabetes mellitus
2. No informed consent
3. Patients with allergic reaction
4. Pregnant, intention of becoming pregnant
5. Patients with history of lactic acidosis
6. Impaired hepatic function (AST>80IU/L or ALT>80IU/L), Impaired renal function [serum-creatinine;
>=1.3mg/dL(male),
>=1.2mg/dL(female)]
7. Patients with pre-proliferative retinopathy, or proliferative retinopathy
8. Patients with the gastrointestinal disorder, such as inflam-matory bowel disease and diabetic gastroparesis
9. Patients with history of pancreatitis
10. Patients with a personal history of medullary thyroid carcinoma (MTC) or those from families with known familial MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
11. Non compliance
12. Patients taking systemic corticosteroids
13. Previous liraglutide treatment
14. Any other condition which the attending physician feels would interfere with the study participation.
Target sample size 110

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
Email ysaisho@keio.jp

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
Email ysaisho@keio.jp

Sponsor
Institute Keio University , School of Mecidicine, Department of Internal Medicine
Institute
Department

Funding Source
Organization Novo Nordisk
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Saitama Social Insurance Hospital, Tokyo Dental College Ichikawa General Hospital, Kitasato Institute Hospital, etc.
Name of secondary funder(s) None

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 慶應義塾大学病院(東京都)
埼玉社会保険病院(埼玉県)
横浜市民病院(神奈川県)
東京歯科大学市川総合病院(千葉県)
永寿総合病院(東京都)
立川病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 10 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 08 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 21 Day
Last modified on
2015 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005087

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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