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

Laniado Hospital

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Basal insulins; Drug: Lixisenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT02767596

LIX001

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Lixisenatide

Experimental group

Description:

S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks

Treatment:

Drug: Lixisenatide

Drug: Basal insulins