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

NCT ID: NCT02767596

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-12

Study Completion Date

2017-02-21

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lixisenatide

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

Group Type EXPERIMENTAL

Lixisenatide

Intervention Type DRUG

Basal insulins

Intervention Type DRUG

patients are on basal insulin treatment

Interventions

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Lixisenatide

Intervention Type DRUG

Basal insulins

patients are on basal insulin treatment

Intervention Type DRUG

Other Intervention Names

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Lyxumia Glargine, Detemir, Degludec

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laniado Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bildirici Diabetes Center, Laniado Hospital

Netanya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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LIX001

Identifier Type: -

Identifier Source: org_study_id

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