Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients

Not Applicable

Recruiting

• Conditions: type 2 Diabetes mellitus

• Registration Number: JPRN-UMIN000047518
• Lead Sponsor: Minami Osaka Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-02
• Study Completion: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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