Back to resultsEvaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
Primary Purpose
Diabetes Mellitus Type 2
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Lixisenatide
Basal insulins
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Type 2 Diabetes Mellitus, treatment, GLP-1
Eligibility Criteria
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)
Sites / Locations
- Bildirici Diabetes Center, Laniado Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lixisenatide
Arm Description
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
Outcomes
Primary Outcome Measures
Change in hemoglobin A1c
Change in body weight
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767596
Brief Title
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment rate
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laniado Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Type 2 Diabetes Mellitus, treatment, GLP-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lixisenatide
Arm Type
Experimental
Arm Description
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lixisenatide
Other Intervention Name(s)
Lyxumia
Intervention Type
Drug
Intervention Name(s)
Basal insulins
Other Intervention Name(s)
Glargine, Detemir, Degludec
Intervention Description
patients are on basal insulin treatment
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c
Time Frame
16 weeks
Title
Change in body weight
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Bildirici Diabetes Center, Laniado Hospital
City
Netanya
ZIP/Postal Code
42150
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
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