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

June 12, 2015 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Investigational Site Number 156001
      • Beijing, China, 100034
        • Investigational Site Number 156033
      • Beijing, China, 100088
        • Investigational Site Number 156006
      • Beijing, China, 100700
        • Investigational Site Number 156005
      • Beijing, China, 100730
        • Investigational Site Number 156004
      • Beijing, China, 100853
        • Investigational Site Number 156002
      • Changchun, China, 130041
        • Investigational Site Number 156016
      • Changsha, China, 410011
        • Investigational Site Number 156025
      • Chengdu, China, 610041
        • Investigational Site Number 156014
      • Chengdu, China, 610072
        • Investigational Site Number 156013
      • Dalian, China, 116027
        • Investigational Site Number 156034
      • Fuzhou, China, 354200
        • Investigational Site Number 156035
      • Guangzhou, China, 510515
        • Investigational Site Number 156021
      • Haikou, China, 570311
        • Investigational Site Number 156023
      • Harbin, China, 150001
        • Investigational Site Number 156017
      • Jinan, China, 250012
        • Investigational Site Number 156026
      • Jinan, China, 250013
        • Investigational Site Number 156029
      • Nanjing, China, 210008
        • Investigational Site Number 156019
      • Nanjing, China, 210011
        • Investigational Site Number 156020
      • Qingdao, China, 266003
        • Investigational Site Number 156018
      • Shanghai, China, 200003
        • Investigational Site Number 156028
      • Shanghai, China, 200072
        • Investigational Site Number 156007
      • Shenyang, China, 110022
        • Investigational Site Number 156032
      • Shijiazhuang, China, 050051
        • Investigational Site Number 156009
      • Siping, China, 136000
        • Investigational Site Number 156036
      • Suzhou, China, 215004
        • Investigational Site Number 156010
      • Tianjin, China, 300052
        • Investigational Site Number 156008
      • Wuhan, China, 430030
        • Investigational Site Number 156027
      • Xi'An, China, 710032
        • Investigational Site Number 156011
      • Xi'An, China, 710061
        • Investigational Site Number 156012
  • India
      • Ahmedabad, India, 380008
        • Investigational Site Number 356019
      • Aligarh, India, 202 002
        • Investigational Site Number 356018
      • Bangalore, India, 560092
        • Investigational Site Number 356026
      • Bhubaneswar, India, 751005
        • Investigational Site Number 356017
      • Hyderabad, India, 500004
        • Investigational Site Number 356002
      • Hyderabad, India, 500063
        • Investigational Site Number 356024
      • Nagpur, India, 440012
        • Investigational Site Number 356015
      • Pune, India, 411001
        • Investigational Site Number 356008
      • Secunderabad, India, 500003
        • Investigational Site Number 356021
      • Visakhapatnam, India, 530002
        • Investigational Site Number 356023
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-703
        • Investigational Site Number 410003
      • Goyang, Korea, Republic of, 411-706
        • Investigational Site Number 410007
      • Seoul, Korea, Republic of, 130-872
        • Investigational Site Number 410006
      • Seoul, Korea, Republic of, 136-705
        • Investigational Site Number 410001
      • Seoul, Korea, Republic of, 139-872
        • Investigational Site Number 410005
      • Wonju, Korea, Republic of, 220-701
        • Investigational Site Number 410002
  • Russian Federation
      • Kirov, Russian Federation, 610014
        • Investigational Site Number 643007
      • Samara, Russian Federation, 443067
        • Investigational Site Number 643006
      • St-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643003
      • St-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643004
      • St-Petersburg, Russian Federation, 195112
        • Investigational Site Number 643005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lixisenatide
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:solution

Route of administration: subcutaneous injection
Placebo Comparator: Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Placebo

Pharmaceutical form:solution

Route of administration: subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: from baseline to week 24
from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with HbA1c <7%, =<6.5%
Time Frame: at week 24
at week 24
Change in 2-hour postprandial plasma glucose and plasma glucose excursion
Time Frame: from baseline to week 24
from baseline to week 24
Change in fasting plasma glucose
Time Frame: from baseline to week 24
from baseline to week 24
Change in 7-point self monitoring plasma glucose profile (average and each point)
Time Frame: from baseline to week 24
from baseline to week 24
Change in body weight
Time Frame: from baseline to week 24
from baseline to week 24
Change in daily basal insulin dose
Time Frame: from baseline to week 24
from baseline to week 24
Number of patients with adverse events
Time Frame: 24 weeks
24 weeks
Anti-lixisenatide antibody assessment
Time Frame: from baseline to week 24
from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (Estimate)

July 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC12382
  • U1111-1124-1213 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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