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Trial record 11 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT02168491
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : April 4, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Michael Krebs, Medical University of Vienna

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Lixisenatide
Drug: Insulin glargine
Enrollment 10
Recruitment Details 11 patients were screened
Pre-assignment Details 2 patients declined to participate because of time restraints, thus study medication was administered in 9 patients
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
65.6  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female 3
Male 6
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Austria Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Change in HbA1c From Baseline to End
Hide Description A change between two time points is reported. Time Frame: baseline and 12 weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description:
Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: HbA1c in percent
-0.54  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide With Basal Insulin (LixiBIT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.02
Comments [Not Specified]
Method paired t test
Comments [Not Specified]
2.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description:
Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Overall Number of Participants Analyzed 9
Mean (95% Confidence Interval)
Unit of Measure: glucose in mg/dl
-9
(-24.1 to 6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide With Basal Insulin (LixiBIT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method paired t test
Comments [Not Specified]
3.Secondary Outcome
Title Change in Body Weight From Baseline to End of Study
Hide Description A change between two time points is reported. Time Frame: baseline and 12 weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description:
Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: weight in kg
-1.4  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide With Basal Insulin (LixiBIT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method paired t test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lixisenatide With Basal Insulin (LixiBIT)
Hide Arm/Group Description Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
All-Cause Mortality
Lixisenatide With Basal Insulin (LixiBIT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide With Basal Insulin (LixiBIT)
Affected / at Risk (%) # Events
Total   1/9 (11.11%)    
Surgical and medical procedures   
elective ENT surgery  1/9 (11.11%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lixisenatide With Basal Insulin (LixiBIT)
Affected / at Risk (%) # Events
Total   3/9 (33.33%)    
Endocrine disorders   
mild asymptomatic hypoglycaemia  3/9 (33.33%)  8
symptomatic hypoglycaemia  1/9 (11.11%)  1
hypercholesterolaemia  2/9 (22.22%)  2
Eye disorders   
elective ambulatory cataract surgery  1/9 (11.11%)  1
Gastrointestinal disorders   
mild gastrointestinal complaints  2/9 (22.22%)  3
General disorders   
cough  1/9 (11.11%)  1
Infections and infestations   
urinary tract infection  2/9 (22.22%)  3
Musculoskeletal and connective tissue disorders   
shoulder pain  1/9 (11.11%)  1
Renal and urinary disorders   
haematuria  1/9 (11.11%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Michael Krebs
Organization: Medical University Vienna, Austria
Phone: + 43 1 40400 ext 43120
EMail: michael.krebs@meduniwien.ac.at
Layout table for additonal information
Responsible Party: Prof. Dr. Michael Krebs, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02168491     History of Changes
Other Study ID Numbers: LixiBIT_V3
2013-005334-37 ( EudraCT Number )
First Submitted: June 12, 2014
First Posted: June 20, 2014
Results First Submitted: December 23, 2016
Results First Posted: April 4, 2017
Last Update Posted: May 9, 2017