Type 2 diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Clinical Research Center,National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with type 2 diabetes mellitus who showed insufficient effect with following treatments. They are dietary and exercise therapy alone or those therapies with diabetic medication excluding DPP-4 inhibitors, such as sulfonylureas, thiazolidinediones, biguanides for more than four weeks. 2)Outpatients between 20 and 80 years old. 3)Individuals who could sign informed consent for this trial.
Exclusion criteria
Exclusion criteria: 1)Patients with type 1 diabetes mellitus 2)Patients who developed diabetic ketoacidosis,or diabetic pre-and coma within 24 weeks of the study entry. 3)Patients with severe infections or severe trauma or perioperative state. 4)Patients with renal insufficiency (CrCl=and>30mL/min, Serum creatinine=and>Male:1.5mg/dl,Female:1.3mg/dl) 5)Patients who received insulin therapy. 6) Patients with severe complication in cardiovascular system within 24 weeks before study entry. 7) Patients with pregnancy, possibility of pregnancy or having a breast feeding. 8)Patients who had a history of hypersensitive reaction to sitagliptin. 9)Patients who are deemed to be inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the proinsulin/ insulin ratio after 48 weeks from the baseline | — |
Countries
Japan
Outcome results
None listed