ClinicalTrials.gg
TerminatedNCT02767596Updated Apr 7, 2017

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

A Phase 4 interventional study of Lixisenatide and Basal insulins in Diabetes Mellitus Type 2, sponsored by Laniado Hospital. Terminated at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by Laniado Hospital · Phase 4, Interventional, and Treatment

Why this study was terminated
Insufficient recruitment rate
Phase
Phase 4
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus Type 2

Keywords

  • Type 2 Diabetes Mellitus
  • treatment
  • GLP-1
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 2 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Laniado Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Type Diabetes Mellitus on combination of basal insulin therapy and GLP1 analog, with secondary failure of non-fasting glycemic control

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating woman
  • Renal failure (\<30)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Lixisenatide

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

    Drug: Lixisenatide · Drug: Basal insulins

Interventions

  • Also known as: Lyxumia

  • DrugBasal insulins

    patients are on basal insulin treatment

    Also known as: Glargine, Detemir, Degludec

06

What researchers measure

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: 16 weeks

  2. Change in body weight

    Time frame: 16 weeks

07

Study locations

1 site
  • Bildirici Diabetes Center, Laniado Hospital
    Netanya, 42150, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Feb 2017, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2016
First posted
May 10, 2016
StartActual
Jul 12, 2016
Primary completionActual
Feb 2017
CompletionActual
Feb 21, 2017
Last update
Apr 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02767596
Lead sponsor
Laniado Hospital
Responsible party
Sponsor
First posted
May 10, 2016
Start date
Jul 12, 2016
Primary completion
Feb 2017
Completion
Feb 21, 2017
Last update
Apr 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lixisenatide

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