UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004243 |
|---|---|
| Receipt number | 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 09:18:18 |
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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
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
ysaisho@keio.jp
Sponsor or person
Institute
Keio University , School of Mecidicine, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005087
