Type 2 diabetes mellitus
Conditions
Interventions
Subjects who assigned to sitagliptin first, will receive 50mg of sitagliptin per day for 7 days and 100mg of sitaglipitn for additional 7 days. Then they will receive 10mg of mitiglinide tid for 14 da
Sponsors
Study group of incretin in Saitama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects should be type 2 diabetic patients who have stable glycemic control for more than 2 months, and their HbA1c (NSGP) should be less than 9.4 %. Subjects who are taking pioglitazone or metformin with DPP-4 inhibitors or glinides will be also enrolled.
Exclusion criteria
Exclusion criteria: 1) Under the treatment with insulin 2) Type 1 diabetic subjects or diabetic subjects who have HbA1c (NSGP) more than or equal to 9.4 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia. 3) Subjects with alpha glucosidase inhibitors. 4) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide). 5) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl]. 6) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors 7) Subjects with previous serious adverse events (possible and prolonged situations to influence usual daily activity or to add hospital admission duration) with DPP-4 inhibitors and glinides. 8) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment. 9) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia). 10) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute 11) Subjects with malignancy 12) Subjects who are pregnant or who have intention to be pregnant 13) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC (area under the curve) of glucagon response during OGTT between sitagliptin treatment and miglitol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Markers of insulin secretion and insulin sensitivity and relation between those markers and effect of medication on glycoalbumin, fasting plasma glucose, and 2hr plasma glucose. | — |
Countries
Japan
Contacts
Public ContactMasafumi Matsuda
Saitama Medical Center, Saitama Medical University Department of Endocrinology and Diabetes
Outcome results
None listed