UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin.
Acronym	Efficacy and safety of Metoformin treatment in pediatric patients with Type 2 diabetes.
Scientific Title	Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin.
Scientific Title:Acronym	Efficacy and safety of Metoformin treatment in pediatric patients with Type 2 diabetes.
Region	Japan

Condition
Condition	Pediatric patients with Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study evaluates the efficacy of metoformin in pediatric patients with Type 2 diabetes. 24-week treatment period is consisting of a titration period of 12 week and a 12 week maintenance period. Primary endpoint is to evaluate the mean change of HbA1c from 12 week titration period to end of 24 week period. The secondary endpoints are BMI, west size, glycoalbumin, FBG, serum lipid levels and the safety variables.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	HbA1c
Key secondary outcomes	BMI, west size, glycoalbumine, FBG, serum lipids levels and safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral administration of Metformin Hydrochloride
Interventions/Control_2
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	10 years-old <=
Age-upper limit	20 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients with Type 2 diabetes treated with diet and exercise for at least 4 weeks or more. 2)Ages 10 or older, but 20 or younger. 3)Following inclusion criteria at 7days before start of treatment. A)Percentage overweight(POW) over 0% B)HbA1c over 5.8% C)Patients who have no sever diabetic complications and no cardiac, liver and kidney functions abnormalities within 7 days before starting treatment (liver function data abnormality due to fatty liver is included) 4)Patients who can be control able with Metoformin mono-therapy. 5)Patients who signed the informed consent by the patient and patients' parent or legal guardian after reading the informed content document. 6)Criteria for previous treatment A)Fresh case: Patients who have no history of medical treatment for diabetes within 28 days prior to the protocol treatment. B)Treated case: (1)Patients who received Metoformin less than 750mg/day, (2) No current treatment with sulfonylurea and less than two hypoglycemic agents at the registration.
Key exclusion criteria	1)Previous treatment with insulin within 28 days before screening visit. 2) Known past history of lactic acidosis. 3) Clinically significant renal disease. 4) On hemodialysis. 5) Clinically significant liver disease (ALT, AST > 2 X ULN) . The patient is eligible if elevated ALT and/or AST is due to fatty liver. 6) On shock, cardiac failure, cardiac or pulmonary infarction and have significant chronic cardiovascular, pulmonary insufficiency and hypoxia. 7) On dehydration. 8) With gastrointestinal disorders such as vomiting or diarrhea. 9) On diabetic ketoacidosis or diabetic coma or precoma. 10) On sever infections, surgery or severe trauma. 11) On malnutrition, starvation, collapse and pituitary or adrenal insufficiency. 12) Pregnant or intend to pregnant during treatment period. 13) History of hypersensitivity to biguanides. 14) Complicated with endocrine disorders such as hyperthyroidism, gigantism, Cushing syndrome, growth hormone deficiency or pheochromocytoma. 15) Complicated with or past history of malignant disorders. 16) History of asymptomatic severs hypoglycemia. 17) History of noncompliance with regards to follow-up medical care. 18) The attending physician's judgement of the patient to be inappropriate for the protocol treatment.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuo Matsuura ,MD
Organization	SEITOKU University
Division name	Faculty of Humanities, Department of Early Childhood Education, Seitoku University
Zip code
Address	550 Iwase, Matsudo, Chiba, 271-8555 Japan
TEL	047-365-1711
Email

Public contact
Name of contact person	1st name Middle name Last name Nobuo Matsuura ,MD
Organization	SEITOKU University
Division name	Faculty of Humanities, Department of Childhood Education, Seitoku University
Zip code
Address	550 Iwase, Matsudo, Chiba, 271-8555 Japan
TEL	047-365-1711
Homepage URL
Email

Sponsor
Institute	Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin study groups.
Institute
Department

Funding Source
Organization	Health and Labour Science Research Grants for Clinical Research on Pediatric disease
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2005 Year 09 Month 15 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	2004 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date	2004 Year 10 Month 01 Day
Last follow-up date	2006 Year 07 Month 01 Day
Date of closure to data entry	2006 Year 11 Month 01 Day
Date trial data considered complete	2006 Year 12 Month 01 Day
Date analysis concluded	2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 13 Day
Last modified on	2008 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000284

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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