UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000216 |
|---|---|
| Receipt number | R000000284 |
| Scientific Title | Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin. |
| Date of disclosure of the study information | 2005/09/15 |
| Last modified on | 2008/06/19 12:52:43 |
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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
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
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000284
