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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005327
Receipt No. R000006064
Scientific Title Comparisons of Oral Agents to Standardize Treatment for diabetes in Japan
Date of disclosure of the study information 2011/03/28
Last modified on 2016/07/18

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Basic information
Public title Comparisons of Oral Agents to Standardize Treatment
for diabetes in Japan
Acronym COAST-J
Scientific Title Comparisons of Oral Agents to Standardize Treatment
for diabetes in Japan
Scientific Title:Acronym COAST-J
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Direct comparisons of efficacy and durability of metformin and DPP-4 inhibitors in the treatment of patients with type 2 diabetes in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) The proportion of participants with HbA1c levels less than 7.0 % at the 52nd week with the Stage One treatment.
2) The proportion of participants with HbA1c levels less than 7.0 % at the 78th,104th,130th, and 156th week with the Stage One treatment.
Key secondary outcomes 1) The proportion of participants with HbA1c levels less than 6.2 % at the 52nd week with the Stage One treatment.
2) The tolerance rate for preselected "therapeutic" dose of the drug for intervention.
3) Percent point change in the HbA1c levels form baseline to post-intervention (at the 4th, 8th, 12th, 24th, 36th, and 52nd week).
4) Values of and change in fasting plasma glucose, body weight, blood pressure, and serum cholesterol , HDL cholesterol, and triglyceride at the 0, 4th, 8th, 12th, 24th, 36th, and 52nd week.
5) Values of and change in serum 1,5-anhydroglucitol at the 0, 4th, 8th, 12th, 24th, and 52nd week.
6) Values of and change in serum glycoalbumin at the 0, 4th, 8th, 12th, 24th week.
7) The proinsulin:insulin ratio, HOMA2-IR, and HOMA2-B before and after 52 weeks after the beginning of the treatment.
8) Values of and change in urine albumin:creatinine ratio at 0, 12th, 24th, 36th, and 52nd week.
9)The proportion of participants who fullfilled the criteria of Stage One treatment, Stage Two treatment, and dropout.
10) The difference between the baseline characteristics and labolatory data of the participants whose HbA1c levels are and are not less than 7% at the 52nd week with the drug of intervention.
11)The proportion of participants with HbA1c levels less than 6.2 % at the 78th,104th,130th, and 156th week with the Stage One treatment.
12) Percent point change in the HbA1c levels from baseline to the 78th, 104th, 130th, and 156th week.
13) Values of and change in fasting plasma glucose level and body weight at the 0, 65th, 78th, 91st, 104th, 117th, 130th, and 156th week.
14)HOMA2-IR, and HOMA2-B at the 104th and 156th week.
15) The adherence of the drug of intervention.
16) The proportion of participants who deviated from the protocol.
17) Safety and adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1) To take 250 to 2250 mg/day (twice or three times a day) of metformin hydrochloride for 52 weeks. Up to the same dose of glimepiride or gliclazide as in the screening period can be used additionally (Stage One treatment).
2) If participants fail to keep the value of HbA1c less than 8.0 % by Stage One treatment, glimepiride (up to 6 mg) is used additionally with metformin hydrochloride until the 52th week (Stage Two treatment).
3) If participants maintain the value of HbA1c less than 7.0 % after the 52th week, Stage One treatment is continued until the 156th week. Stage One treatment is discontinued when HbA1c level reaches 8.0%.
Interventions/Control_2 1) To take one of the DPP-4 inhibitors for 52 weeks. Up to the same dose of glimepiride or gliclazide as in the screening period can be used additionally (Stage One treatment).
2) If participants fail to keep the value of HbA1c less than 8.0 % by Stage One treatment, glimepiride (up to 6 mg) is used additionally with one of the DPP-4 inhibitors until the 52th week (Stage Two treatment).
3) If participants maintain the value of HbA1c less than 7.0 % after the 52th week, Stage One treatment is continued until the 156th week. Stage One treatment is discontinued when HbA1c level reaches 8.0%.
Interventions/Control_3 1) To continue the therapy for diabetes mellitus during the screening period. Up to the same dose of glimepiride or gliclazide as in the screening period can be used (Stage One treatment).
2) If participants fail to keep the value of HbA1c less than 8.0 % by Stage One treatment, glimepiride (up to 6 mg) is used additionally with Stage One treatment until the 52th week (Stage Two treatment).
3) If Stage One treatment maintain the value of HbA1c less than 7.0 % after the 52th week, Stage One treatment is continued until the 156th week. Stage One treatment is discontinued when HbA1c level reaches 8.0%.
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
72 years-old >
Gender Male and Female
Key inclusion criteria 1. Diagnosis of type 2 diabetes mellitus by the criteria of Japan Diabetes Society.
2. If female, not currently pregnant or not planning pregnancy during the study period.
3. Body mass index less than 30 kg/m2.
4. Diabetes is treated with any of the following therapies with three month prior to study enrollment: (1) medical nutrition therapy alone; (2) monotherapy with the same dose of glimepiride (=< 4mg per day); (3) monotherapy with the same dose of gliclazide (=< 80mg per day).
5. 7% =< HbA1c < 9%.
6. Stable HbA1c (difference between the HbA1c of the latest visit (21 days to three months before the screening visit) and that of the screening visit is less than or equal to 1.0% points).
7. Stable HbA1c (difference between the HbA1c of all the visits (within 20 days before the screening visit, if any) and that of the screening visit are less than or equal to 1.0% points)
8. Subject has given full written informed consent prior to the study.
Key exclusion criteria 1. Pregnancy or lactation.
2. Previous adverse effects on either metformin or DPP-4 inhibitors.
3. a)GADA positivity, history of lactic acidosis, or severe complication derived from diabetes or other diseases, b)history of diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, or massive ketonuria within 6 months prior to screening visit.
4. Episode of severe infection, massive hemorrhage or donation of blood within 4 weeks prior to screening visit.
5. Administeration glucocorticoids or immunosuppressive medications.
6. Renal insufficiency (value of serum creatinine equal to or above 1.3mg/dL in man or equal to or above 1.2mg/dL in women or eGFR less than 40).
7. Abnormal liver function (value of AST and/or ALT more than the double of the normal upper limit) or liver cirrosis.
8.Presence of edema.
9.Heart failure.
10.Respiratory failure.
11.Alcohol abuse.
12.Hematological diseases including anemia (Hb value less than 11g/dL in men and less than 10g/dL in women).
13.Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits.
14.Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Target sample size 1326

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Noda
Organization National Center for Global Health and Medicine
Division name Department of Diabetes and Metabolic Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-5273-6955
Email dm-ing5@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ritsuko Yamamoto-Honda
Organization National Center for Global Health and Medicine
Division name Department of Diabetes and Metabolic Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-5273-6955
Homepage URL http://ncgm-dm.jp/coast-j/index.html
Email dm-ing5@hosp.ncgm.go.jp

Sponsor
Institute Department of Diabetes and Metabolic Medicine, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Japan Foundation for the Promotion of International Medical Research Cooperation (until 31/March/2013)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 独立行政法人国立国際医療研究センター病院(東京都)、独立行政法人国立国際医療研究センター国府台病院(千葉県)、信州大学大学附属病院(長野県)、徳島大学病院(徳島県)、国家公務員共済組合連合会 虎の門病院(東京都)、JR東京総合病院(東京都)、社会福祉法人 三井記念病院(東京都)、日本赤十字社大森赤十字病院(東京都)、岐阜大学医学部附属病院(岐阜県)、笹塚井上クリニック(東京都)、社会保険中央病院(東京都)、東京都保健医療公社 多摩北部医療センター(東京都)、医療法人社団 六医会インペリアルタワー診療所(東京都)、医療法人康麗会 笛吹中央病院(山梨県)、医療法人 慈誠会 山根病院(島根県)、福島県立医科大学附属病院(福島県)、名古屋大学医学部附属病院老年内科(愛知県)、香川県立中央病院(香川県)、福山市民病院(広島県)、飯塚市立病院(福岡県)、やごうクリニック(東京都)、国家公務員共済組合連合会 三宿病院(東京都)、山本診療所(福岡県)、下奥多摩医院(東京都)、小山イーストクリニック(栃木県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 28 Day

Related information
URL releasing protocol http://ncgm-dm.jp/coast-j/index.html
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 18 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 28 Day
Last modified on
2016 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006064

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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