UMIN ID: C000000216
Registered date:15/09/2005
Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Pediatric patients with Type 2 diabetes |
| Date of first enrollment | 2004/10/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | oral administration of Metformin Hydrochloride |
Outcome(s)
| Primary Outcome | HbA1c |
|---|---|
| Secondary Outcome | BMI, west size, glycoalbumine, FBG, serum lipids levels and safety |
Key inclusion & exclusion criteria
| Age minimum | 10years-old |
|---|---|
| Age maximum | 20years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin study groups. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Health and Labour Science Research Grants for Clinical Research on Pediatric disease |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nobuo Matsuura ,MD |
| Address | 550 Iwase, Matsudo, Chiba, 271-8555 Japan Japan |
| Telephone | 047-365-1711 |
| Affiliation | SEITOKU University Faculty of Humanities, Department of Childhood Education, Seitoku University |
| scientific contact | |
| Name | Nobuo Matsuura ,MD |
| Address | 550 Iwase, Matsudo, Chiba, 271-8555 Japan Japan |
| Telephone | 047-365-1711 |
| Affiliation | SEITOKU University Faculty of Humanities, Department of Early Childhood Education, Seitoku University |