- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767596
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
A Pilot Single-Arm Open-Label Study to Evaluate the Efficacy of Treatment With Lixisenatide in Diabetes Mellitus Type 2 Patients With Failure of Other GLP-1 Analog
The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting GLP-1 analog.
Patients who fail to achieve significant improvement in diabetes control on basal insulin and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The primary outcomes will be changes in HBA1C and weight.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Netanya, Israel, 42150
- Bildirici Diabetes Center, Laniado Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Type Diabetes Mellitus on combination of basal insulin therapy and GLP1 analog, with secondary failure of non-fasting glycemic control
Exclusion Criteria:
- Pregnant or lactating woman
- Renal failure (eGFR<30)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lixisenatide
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
|
Other Names:
patients are on basal insulin treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemoglobin A1c
Time Frame: 16 weeks
|
16 weeks
|
Change in body weight
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIX001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Lixisenatide
-
SanofiCompletedType 2 Diabetes MellitusJapan
-
SanofiCompletedType 2 DiabetesUnited States, Canada, Brazil, Poland, Romania, Russian Federation, Ukraine
-
SanofiCompletedType 2 Diabetes MellitusChina, India, Korea, Republic of, Russian Federation
-
SanofiCompletedType 2 Diabetes MellitusSouth Africa, United States, Mexico, United Kingdom
-
SanofiCompletedAcute Coronary SyndromeBelgium, China, Japan, Denmark, United States, Belarus, Mexico, Philippines, Israel, Austria, Serbia, Estonia, Lithuania, Chile, Colombia, Germany, Latvia, Peru, Ukraine, Egypt, Italy, France, Brazil, India, Guatemala, South Africa, Taiwan, C... and more
-
SanofiProfil GmbH, Neuss, GermanyCompletedDiabetes Mellitus, Type 2Germany
-
SanofiTerminatedType II Diabetes Mellitus
-
SanofiCompleted
-
University Hospital, Gentofte, CopenhagenMCM Vaccines B.V.CompletedThe Impact of Lixisenatide on Postprandial Glucose Tolerance in Pancreatectomised Subjects (Px-Lixi)Diabetes After Total Pancreatectomy