Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767596
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 10, 2016
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Laniado Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date April 7, 2017
Actual Study Start Date  ICMJE July 12, 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Change in hemoglobin A1c [ Time Frame: 16 weeks ]
  • Change in body weight [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • Drug: Lixisenatide
    Other Name: Lyxumia
  • Drug: Basal insulins
    patients are on basal insulin treatment
    Other Name: Glargine, Detemir, Degludec
Study Arms  ICMJE Experimental: Lixisenatide
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
Interventions:
  • Drug: Lixisenatide
  • Drug: Basal insulins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 6, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2016)
20
Actual Study Completion Date  ICMJE February 21, 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02767596
Other Study ID Numbers  ICMJE LIX001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laniado Hospital
Study Sponsor  ICMJE Laniado Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Laniado Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP