Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes under long-term insulin injection 2. Age between 40 and 86 years 3. Insulin dosage >10 units/24 h 4. Insulin injection duration >3 months 5. C-peptide in 24-hr urine >10 micrograms 6. Fasting CPR >0.5 ng/ml
Exclusion criteria
Exclusion criteria: 1. Positive for glutamine acid decarboxylase antibody 2. ALT and/or AST >3 times the upper limit of normal 3. Presently and/or in the past suffering from heart failure 4. Ejection fraction assessed by echocardiography 50% positivity for insulin antibody 9. Diagnosis of type I diabetes 10. Pregnant or breast feeding 11. Under dialysis 12. Concomitantly using pioglitazone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of success in the study. Success is defined as HbA1c at four months after the switch <7.0%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mean HbA1C from the baseline compared to four-month timepoint. Differences among values of the following are also assessed (measured at months 0 and 4): 1. Serum lipid concentrations 2. Blood pressure 3. Body weight 4. Hematocrit 5. Albumin 6. Blood urea nitrogen 7. Creatinine 8. Aspartate Transaminase (AST) 9. Alanine Transaminase (ALT) | — |
Countries
Japan