Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-UMIN000041551
• Lead Sponsor: Minami Osaka Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-25
• Study Completion: 2021-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.