type 2 diabetes
Conditions
Interventions
combination of insulin glargine and lixisenatide + glulisine therapy
intensive insulin therapy
Sponsors
Minami Osaka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and who have been treated with oral hypoglycemic drugs for more than 6 months before the screening. 2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%.
Exclusion criteria
Exclusion criteria: 1. Patients with severe gastrointestinal disorders such as severe gastroparesis. 2. Patients with a history of pancreatitis. 3. Patients with a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of starting the study. 4.Patients with severe hypoglycemia (diabetic coma or precoma, convulsion that requires the assistance of a third party) within 6 weeks of starting the study. 5. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level 2.0mg/dL or more) or patients with end-stage renal failure undergoing dialysis. 6. Patients with severe liver dysfunction (AST or ALT higher than 100U/L). 7. Patients with proliferative retinopathy (however, patients with stable symptoms who have undergone photocoagulation, etc. can be enrolled). 8. Pregnant or possibly pregnant women and lactating patients. 9. Patients with severe infections, serious injury before and after surgery. 10. Patients receiving systemic corticosteroids. 11. Patients with a history of allergies to the planned drug used in the study. 12. Patients with or history of malignancy. 13.Other patients who the investigator determined to be inappropriate as a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy:Percentage of time of the glucose level of euglycemic area (70-179 mg/dl) of flash glucose monitoring (FGM). safety:Percentage of time less than 70 mg/dl (low blood glucose area) of FGM. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in FGM. Mean blood glucose (24hours, 0:00-6:00, 6:00-18:00, 18:00-24:00), SD value(24hours, 6:00-18:00), CV value(24hours, 6:00-18:00), percentage of time of the glucose level of euglycemic area (70-179 mg/dl of FGM(6:00-24:00), daily variation , M value, MAGE, changes in glycoalbumin levels,period until target blood glucose level is reached and titration is completed. | — |
Countries
Japan
Contacts
Public ContactYuji Kawaguchi
Minami Osaka Hospital Internal Medicine
Outcome results
None listed