Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inadequately controlled type 2 diabetic patients who are taking sulfonylurea (glymepiride at a dose of 1 mg to 2 mg)for more than 1 month. Patients whose HbA1c ranges from 7.0% to 9.0% (JDS value).
Exclusion criteria
Exclusion criteria: 1. Patients who had diabetic ketoacidosis, or diabetic pre- and coma within 6 months of the study entry. 2. Patients who received surgery operation during the study. 3. Patients with pregnancy or Nursing mothers 4. Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl) 5. Patients who received insulin therapy 6. Patients who had a history of hypersensitivity reaction to sitagliptin 7. Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum C peptide concentration Intact proinsulin/insulin ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c, fasting plasma glucose, HOMA-beta LDL cholesterol, HDL chplesterol, triglyceride, urinary albumin, cystatin C, high sensitivity C-reactive protein, high molecular weight adiponectin | — |
Countries
Japan
Contacts
Dokkyo Medical University Department of Endocrinology and Metabolism