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Trial record 3 of 63 for:    Lixisenatide
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Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Lixisenatide Drug: Basal insulins Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 21, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Lixisenatide
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
 Drug: Lixisenatide
Other Name: Lyxumia

Drug: Basal insulins
patients are on basal insulin treatment
Other Name: Glargine, Detemir, Degludec


Outcome Measures
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Primary Outcome Measures :
  1. Change in hemoglobin A1c [ Time Frame: 16 weeks ]
  2. Change in body weight [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767596


Locations
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Israel
Bildirici Diabetes Center, Laniado Hospital
Netanya, Israel, 42150
Sponsors and Collaborators
Laniado Hospital
More Information
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Responsible Party: Laniado Hospital
ClinicalTrials.gov Identifier: NCT02767596    
Other Study ID Numbers: LIX001
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Laniado Hospital:
Type 2 Diabetes Mellitus
treatment
GLP-1
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Lixisenatide
Hypoglycemic Agents
Physiological Effects of Drugs