Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

PHASE3CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide

Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.

DRUG

Insulin glargine

Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.

Trial Locations (1)

1090

Medical University Of Vienna, Department of Internal Medicine III, Vienna

All Listed Sponsors
lead

Medical University of Vienna

OTHER

NCT02168491 - Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin | Biotech Hunter | Biotech Hunter