Type 2 diabetes Mellitus (T2DM)
Conditions
Interventions
* Orally take a dose of 100 mg of anagliptin twice a day in the morning and evening in addition to the medicines taken at time of consenting * If patients are at a risk of hypoglycemia, start with
Sponsors
Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Patients who was diagnosed as T2DM 2. At age of 20 or older at time of giving consent 3. HbA1c 7% or higher, and below 11% with less than 1% changes within 12 weeks prior to patients provide consent 4. Patients without any changes (adding, suspending, or changing doses) in their treatment for T2DM (excluding insulin dosage changes) within 8 weeks prior to giving their consent 5. In addition to insulin, no more than three medications from the following are used: biguanide, sulfonylurea and thiazolidinedione medicines, rapid-acting insulin secretion promoter, SGLT2 and alpha-glucosidase inhibitors 6. Patients who are on diet and physical exercise therapies 7. Outpatients 8. Female or male 9. Patients who are capable of making a decision by themselves, and can provide written consent
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are unable to participate in the study. 1. Patients with type 1 diabetes mellitus 2. Patients with insulin dose increased 4 units during the observation times [-12 weeks from baseline] 3. Patients with kind of insulin preparation changed during the observation times 4. Patients who have an experience of taking anagliptin in the past 5. Patients with BMI 30 kg/m2 or greater 6. Patients with severe liver impairment (e.g. decompensated cirrhosis), or either AST or ALT 100 IU/L or higher during the observation times 7. Patients with severe renal impairment (e.g. renal failure), or serum creatinine 1.5 mg/dL or higher during the observation times 8. Patients with severe heart impairment (e.g. heart failure, unstable angina), or have myocardial infarct or angina attack within 24 weeks of the observation times 9. Stroke (cerebral infarction, brain hemorrhage) within 24 weeks before providing consent 10. Patients with malignancy 11. Patients with severe diabetic complications (neuropathy, retinopathy, and nephropathy) 12. Patients with severe ketosis, diabetic coma or precoma 13. Patients with endocrine disease which needs more than hormone replacement therapy (e.g. pituitary, thyroid, or adrenal disease) 14. Patients who have moderate to severe anemia (hemoglobin is below 9.5g/dL) 15. Patients with intestine disease which shows abnormality in digestion and absorption 16. Patients with a medical history digestive organ ablation (excepting cutting appendix) 17. Patients who are excessive alcohol drinkers (e.g. an average of 3 Go of Japanese wine, or 3 large bottles of beer, or more) 18. Patients with other reasons that the responsive investigators or other investigators think inappropriate to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of plasma glucagon AUC 0-180 min before and after using anagliptin (the conventional and LC-MS/MS methods) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of plasma glucagon from the time before breakfast at each observation point before and after using anagliptin (the conventional and LC-MS/MS methods) 2. Change of plasma glucagon AUC 0-120 min before and after using anagliptin (the conventional and LC-MS/MS methods) 3. Correlation between glucagon values measured by the conventional and LC-MS/MS methods 4. Changes from the time before breakfast at each observation point in GIP and GLP-1 active form in plasma, total GLP-1, precision serum C-peptide, and glucose 5. Comparisons of the following items between baseline and the week 4: GIP and GLP-1 active form in plasma, total GLP-1, precision serum C-peptide, glucose, body weight and blood pressure. Frequencies of adverse events (including abnormal values in clinical examinations) | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed