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NCT02767596 Clinical Trial

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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02767596
Other study ID # LIX001
Secondary ID
Status Terminated
Phase Phase 4
First received April 3, 2016
Last updated April 6, 2017
Start date July 12, 2016
Est. completion date February 21, 2017

Study information
Verified date April 2017
Source Laniado Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date February 21, 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lixisenatide

• Basal insulins
patients are on basal insulin treatment

Locations
Country Name City State
Israel Bildirici Diabetes Center, Laniado Hospital Netanya

Sponsors (1)
Lead Sponsor Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in hemoglobin A1c 16 weeks
Primary Change in body weight 16 weeks
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