type 2 diabetes
Conditions
Interventions
After treatment of hypertension at least 12 weeks with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACE-Is) in usual dose, patients receive pioglitazone 15mg/day.
Sponsors
Department of Medicine, Asahikawa Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Type 2 diabetic patient 2.Patient who is treated with diet alone, insulin or oral hypoglycemic agents except metformin and/or pioglitazone (only clinically used thiazolidinedione in Japan). If metformin and/or pioglitazone had already been administered, they were withdrawn from patient at 4 weeks before screening. 3.HbA1c between 6.9% and 9.4% with stable glycemic control 4.Patient who is receiving anti-hypertensive treatment with RAS-Is over 12 weeks. 5.Patient with microalbuminuria (defined by twice measured urinary albumin-to-creatinine ratio of 30 mg/gCr or greater and less than 300 mg/gCr in first morning urine samples in the screening period.
Exclusion criteria
Exclusion criteria: 1.serum creatinine >1.5 mg/dl at baseline 2.a history of side effects with pioglitazone or metformin. 3.present or past history of congestive heart failure, myocardial infarction, pulmonary embolism. 4.alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > twofold the upper limit of normal. 5.pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urinary albumin-to-creatinine ratio (UACR) from baseline to week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to week 52 | — |
Countries
Japan
Contacts
Public ContactAkizuki Morikawa
Asahikawa Red Cross Hospital Department of Internal Medicine
Outcome results
None listed