Trial Outcomes & Findings for Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin (NCT NCT02168491)

NCT ID: NCT02168491

Last Updated: 2017-05-09

Results Overview

A change between two time points is reported. Time Frame: baseline and 12 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-05-09

Participant Flow

11 patients were screened

2 patients declined to participate because of time restraints, thus study medication was administered in 9 patients

Participant milestones

Measure	Lixisenatide With Basal Insulin (LixiBIT) Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide 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. 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
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Lixisenatide With Basal Insulin (LixiBIT) Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide 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. 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

Overall Study Withdrawal by Subject

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 Participants Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Age, Continuous	65.6 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Austria	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

A change between two time points is reported. Time Frame: baseline and 12 weeks.

Outcome measures

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 Participants Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Change in HbA1c From Baseline to End	-0.54 HbA1c in percent Standard Deviation 0.52

SECONDARY outcome

Timeframe: 12 weeks

Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin.

Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study.

During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control.

Outcome measures

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 Participants Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)	-9 glucose in mg/dl Interval -24.1 to 6.1

SECONDARY outcome

Timeframe: 12 weeks

A change between two time points is reported. Time Frame: baseline and 12 weeks.

Outcome measures

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 Participants Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Change in Body Weight From Baseline to End of Study	-1.4 weight in kg Standard Deviation 3.6

Adverse Events

Lixisenatide With Basal Insulin (LixiBIT)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 participants at risk Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Surgical and medical procedures elective ENT surgery	11.1% 1/9 • Number of events 1

Other adverse events

Measure	Lixisenatide With Basal Insulin (LixiBIT) n=9 participants at risk Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Endocrine disorders mild asymptomatic hypoglycaemia	33.3% 3/9 • Number of events 8
Gastrointestinal disorders mild gastrointestinal complaints	22.2% 2/9 • Number of events 3
Infections and infestations urinary tract infection	22.2% 2/9 • Number of events 3
Endocrine disorders symptomatic hypoglycaemia	11.1% 1/9 • Number of events 1
Endocrine disorders hypercholesterolaemia	22.2% 2/9 • Number of events 2
Renal and urinary disorders haematuria	11.1% 1/9 • Number of events 1
General disorders cough	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders shoulder pain	11.1% 1/9 • Number of events 1
Eye disorders elective ambulatory cataract surgery	11.1% 1/9 • Number of events 1

Additional Information

Prof. Dr. Michael Krebs

Medical University Vienna, Austria

Phone: + 43 1 40400

Email: michael.krebs@meduniwien.ac.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place