There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.

Inclusion Criteria:

• outpatients with type 2 diabetes
• addition of sitagliptin to insulin therapy
• aged 20 years or older
• HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

Exclusion Criteria:

• history of hypersensitivity to sitagliptin
• severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration
• sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery
• severe renal dysfunction (serum creatinine [mg/dL]: 2.5 or higher for men; 2.0 or higher for women)
• ongoing treatment with glinide(s)
• judgment as ineligible for the study by the attending physician

One-thousand Japanese patients with type 2 diabetes