type 2 Diabetes mellitus
Conditions
Interventions
Insulin glargine U-100/lixisenatide combination injection for 20 weeks.
Insulin degludec/liraglutide combination injection for 20 weeks.
Sponsors
Minami Osaka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and have been treated with oral hypoglycemic agents for more than 6 months before the screening. Patients with HbA1c levels 7.0% or more and less than 11.0%.
Exclusion criteria
Exclusion criteria: Patients with gastrointestinal disorders such as gastroparesis and inflammatory bowel disease Patients with a history of pancreatitis The following patients or conditions that may cause hypoglycemia Gastrointestinal disorders such as diarrhea and vomiting Pituitary insufficiency or adrenal insufficiency Malnutrition, starvation, irregular dietary intake, lack of dietary intake or weakness Intense muscle exercise Excessive alcohol intake Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal disease Patients with severe liver dysfunction (high AST or ALT of 100 U/L or more) Patients who have been treated with Insulin glargine U-100/lixisenatide or Insulin degludec/liraglutide in the past Pregnant or potentially pregnant women and lactating patients Other patients judged by the investigator to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of blood glucose level 70-180 mg/dl (time in range) in isCGM. The percentage of time when the blood glucose level is less than 70 mg/dl (time below range) in isCGM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbA1c levels Percentage of blood glucose levels above 180 mg/dl (time above range) in isCGM. Percentage of blood glucose levels below 54 mg/dl (severe hypoglycemia) in isCGM. Percentage of nocturnal hypoglycemic range (0: 00-5: 59, <70 mg/dl) in isCGM. Average blood glucose level in isCGM (24 hours, 0:00 to 6:00, 6:00 to 18:00, 18:00 to 24:00). As a blood glucose fluctuation index SD value (standard deviation of blood glucose fluctuation) (24 hours, 6: 00-18: 00) CV value (coefficient of variation of blood glucose) (24 hours, 6: 00-18: 00) Percentage of blood glucose levels 70-180 mg/dl (time in range) from 6:00 to 24:00. MODD (daily fluctuation) M value MAGE (mean amplitude of glycemic excursions) Degree of change in body weight Change in glycoalbumin Correlation between changes in CPI (serum c-peptide index) value and glycemic control index | — |
Countries
Japan
Contacts
Public ContactYuji Kawaguchi
Minami Osaka Hospital Internal Medicine
Outcome results
None listed