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Trial record 3 of 63 for:    Lixisenatide

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. Identifier: NCT02767596
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 10, 2016
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT02767596

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Bildirici Diabetes Center, Laniado Hospital
Netanya, Israel, 42150
Sponsors and Collaborators
Laniado Hospital
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Responsible Party: Laniado Hospital 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs