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

NCTNCT02767596Other idLIX001

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Insufficient recruitment rate

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 2 participants (actual)
Sponsor: Laniado Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Israel
Start: 12 Jul 2016
Primary completion: Feb 2017
Completion: 21 Feb 2017
First posted: 10 May 2016 (estimated)
Last update posted: 7 Apr 2017
Conditions: Diabetes Mellitus Type 2

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018

Ph 4
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
NCT02767596
12 Jul 2016 to 21 Feb 2017
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LixisenatideDrug
Basal insulinsDrug

Arms1

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in hemoglobin A1c
Time frame · 16 weeks
Change in body weight
Time frame · 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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