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Trial · Interventional

CompletedPhase 3Registry data

Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

NCTNCT01632163 (opens ClinicalTrials.gov in a new tab)Other idEFC12382Other idU1111-1124-1213
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
447 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Triple masking
Countries
4 countries

China, India, Russia, South Korea

Start
Oct 2012
Primary completion
May 2015
Completion
May 2015
First posted
2 Jul 2012 (estimated)
Last update posted
15 Jun 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 3

    Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

    NCT01632163

    Oct 2012 to May 2015

Registry summary

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

Primary Objective: \- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives: * To assess the effects of lixisenatide over 24 weeks on : * percentage of patients reaching HbA1c\<7% or ≤6.5%, * 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, * fasting plasma glucose (FPG), * change in 7-point self-monitored plasma glucose (SMPG) profile), * body weight, * change in daily basal insulin dose. * To assess lixisenatide safety and tolerability. * To assess anti-lixisenatide antibody development.

Interventions

  • Lixisenatide (AVE0010)Drug
  • PlaceboDrug

Arms2

  • Experimental

    Lixisenatide

    24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)

  • Placebo comparator

    Placebo

    24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · from baseline to week 24

Secondary outcomes(8)

  1. Percentage of patients with HbA1c <7%, =<6.5%

    Time frame · at week 24

  2. Change in 2-hour postprandial plasma glucose and plasma glucose excursion

    Time frame · from baseline to week 24

  3. Change in fasting plasma glucose

    Time frame · from baseline to week 24

  4. Change in 7-point self monitoring plasma glucose profile (average and each point)

    Time frame · from baseline to week 24

  5. Change in body weight

    Time frame · from baseline to week 24

  6. Change in daily basal insulin dose

    Time frame · from baseline to week 24

  7. Number of patients with adverse events

    Time frame · 24 weeks

  8. Anti-lixisenatide antibody assessment

    Time frame · from baseline to week 24

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.

Completed trials do not always post results.

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2023

2 results

Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis.

Yao et al. 2023Diabetes therapy : research, treatment and education of diabetes and related disorders

PMID 36809495PMC10064411DOI 10.1007/s13300-023-01369-6PUB-36809495

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2018

8 results

Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.

Yang et al. 2018Diabetes, obesity & metabolismcited by 32

PMID 28742225PMC5813270DOI 10.1111/dom.13072PUB-28742225

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria : \- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin. Exclusion criteria: At screening: * Age \< legal age of adulthood. * HbA1c\<7% or \>10.5%. * Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit. * If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit. * History of hypoglycemia unawareness. * Body Mass Index (BMI) ≤20 kg/m². * Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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