Pediatric patients with Type 2 diabetes
Conditions
Interventions
oral administration of Metformin Hydrochloride
Sponsors
Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin study groups.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI, west size, glycoalbumine, FBG, serum lipids levels and safety | — |
Countries
Japan
Contacts
Public ContactNobuo Matsuura ,MD
SEITOKU University Faculty of Humanities, Department of Childhood Education, Seitoku University
Outcome results
None listed