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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000216 |
Receipt No. | 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 |
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. | |
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Condition | |||
Condition | Pediatric patients with Type 2 diabetes | ||
Classification by specialty |
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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
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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 |
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Interventions/Control_1 | oral administration of Metformin Hydrochloride | |
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Eligibility | ||||
Age-lower limit |
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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. |
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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. |
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Target sample size | 50 |
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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 | ||||||
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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 | |
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. |
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Funding Source | |
Organization | Health and Labour Science Research Grants for Clinical Research on Pediatric disease |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |