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

Phase 2

• Conditions: Pediatric patients with Type 2 diabetes

• Registration Number: JPRN-C000000216
• Lead 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.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-15
• Study Completion: 2006-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c

Secondary Outcome Measures

Name	Time	Method
BMI, west size, glycoalbumine, FBG, serum lipids levels and safety