Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
Phase 4
Terminated
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: Basal insulins
- Registration Number
- NCT02767596
- Lead Sponsor
- Laniado Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lixisenatide Basal insulins S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks Lixisenatide Lixisenatide S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
- Primary Outcome Measures
Name Time Method Change in hemoglobin A1c 16 weeks Change in body weight 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bildirici Diabetes Center, Laniado Hospital
🇮🇱Netanya, Israel