NCT02767596

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 3, 2016

Last Update Submit

April 6, 2017

Conditions

Diabetes Mellitus Type 2

Keywords

Type 2 Diabetes MellitustreatmentGLP-1

Outcome Measures

Primary Outcomes (2)

  • Change in hemoglobin A1c

    16 weeks

  • Change in body weight

    16 weeks

Study Arms (1)

Lixisenatide

EXPERIMENTAL

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

Drug: LixisenatideDrug: Basal insulins

Interventions

LixisenatideDRUG
Also known as: Lyxumia
Lixisenatide
Basal insulinsDRUG

patients are on basal insulin treatment

Also known as: Glargine, Detemir, Degludec
Lixisenatide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant or lactating woman
  • Renal failure (eGFR\<30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bildirici Diabetes Center, Laniado Hospital

Netanya, 42150, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatideInsulin GlargineInsulin Detemirinsulin degludec

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2016

First Posted

May 10, 2016

Study Start

July 12, 2016

Primary Completion

February 1, 2017

Study Completion

February 21, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)