Patients with type II diabetes mellitus
Conditions
Interventions
Prescription of oral Anagliptin 100 mg twice daily, morning and night. Furthermore, if the effect is insufficient, the dose can be increased up to 200 mg as required, under supervision. The period of
Sponsors
Arc Cardiovascular Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of type II diabetes mellitus 2) HbA1c less than 10.0% 3) Fluctuation range within +/-1.0% for the previous two HbA1c levels 4) Patients 20 years of age and older (regardless of gender) 5) Patients using DPP-4 inhibitors (limited to single daily dose preparations) other than Anagliptin 6) Patients who have provided written consent for participation in this study
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to the components of Anagliptin 2) Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus 3) Patients with severe infection or severe trauma, and pre- or post-operative patients 4) Patients with severe renal impairment or on dialysis with end-stage renal failure 5) Patients with a history of abdominal surgery (limited to gastrointestinal surgery) or intestinal obstruction 6) Women who are currently pregnant or may be pregnant, or women who are currently breastfeeding 7) Patients who are currently on continual insulin preparations or have been determined to require insulin preparations 8) Patients who are currently using GLP-1 receptor agonist medication or have been determined to require GLP-1 receptor agonist medication 9) Patients who may have allergy to wheat or eggs 10) Patients who may have difficulty conducting the test meal loading (no alcohol the previous day, 10 hours fasting, etc.) 11) Patients determined to be unsuitable for participation in the study by the research investigators or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glucagon AUC0-2h during test meal loading one month after Anagliptin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in all types of parameters during test meal loading before and after Anagliptin administration. (1)Glucagon level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h) (2)Blood glucose level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h) (3)Insulin level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h) (4)C-peptide (fasting, delta 0-30 min, incremental AUC0-1h, incremental AUC0-2h) (5)Insulin/glucagon ratio Changes in laboratory test results before and after Anagliptin administration AST(GOT), ALT(GPT), gamma-GTP, serum creatinine, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglyceride, HbA1c | — |
Countries
Japan
Contacts
Public ContactShu Yanagisawa
Arc Cardiovascular Clinic Arc Cardiovascular Clinic
Outcome results
None listed