type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants were eligible if they were at least 20 years old, had type 2 diabetes mellitus, poorly controlled diabetes (HbA1c levels >6.9% within 12 weeks before screening), and had been treated with diet therapy and/or a single OHA, such as sulfonylurea (SU), biguanide (BG), thiazolidinedione (TZD) or dipeptidyl peptidase-4 (DPP-4) inhibitor class drugs, for 12 weeks or longer.
Exclusion criteria
Exclusion criteria: Exclusion criteria were: (1) hypersensitivity or a contraindication to sitagliptin or voglibose; (2) history of type 1 diabetes; (3) history of ketoacidosis; (4) having experienced symptoms of hypoglycemia; (5) treatment with sitagliptin or voglibose within 12 weeks before screening; (6) treatment with insulin within 12 weeks before screening; (7) concomitant corticosteroid therapy; (8) poorly controlled or unstable diabetes (the state with ketoacidosis or with an increase in HbA1c >3% in the 12 weeks before screening); (9) alanine aminotransferase and/or aspartate aminotransferase levels more than 2.5-fold the upper limit of normal; (10) poorly controlled hypertension or systolic blood pressure >160 mm/Hg or diastolic blood pressure >100 mm/Hg; (11) presence of a severe health problem not suitable for the study; (12) pregnancy or breastfeeding; or (13) inability to participate in the study due to psychiatric or psychosocial status as assessed by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels, urinary albumin-to-creatinine ratio, and urinary L-FABP-to-creatinine ratio over 16 weeks | — |
Countries
Japan
Contacts
Tokushima University Graduate School of Biomedical Sciences Department of Community Medicine and Medical Science