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Type 2 Diabetes MellitusPhase 3NCT01632163

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

A Phase 3 study testing Lixisenatide (AVE0010) in people with Type 2 Diabetes Mellitus, run by Sanofi at 51 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Lixisenatide (AVE0010)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
447 participants
Where
51 sitesin 4 countries
Study dates
Oct 2012to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

51 sites in 4 countries.

51 sites in 4 countries

China30 sites

  • Investigational Site Number 156001

    Beijing, 100029

  • Investigational Site Number 156033

    Beijing, 100034

  • Investigational Site Number 156006

    Beijing, 100088

  • Investigational Site Number 156005

    Beijing, 100700

  • Investigational Site Number 156004

    Beijing, 100730

  • Investigational Site Number 156002

    Beijing, 100853

  • Investigational Site Number 156016

    Changchun, 130041

  • Investigational Site Number 156025

    Changsha, 410011

  • Investigational Site Number 156014

    Chengdu, 610041

  • Investigational Site Number 156013

    Chengdu, 610072

  • Investigational Site Number 156034

    Dalian, 116027

  • Investigational Site Number 156035

    Fuzhou, 354200

  • Investigational Site Number 156021

    Guangzhou, 510515

  • Investigational Site Number 156023

    Haikou, 570311

  • Investigational Site Number 156017

    Harbin, 150001

  • Investigational Site Number 156026

    Jinan, 250012

  • Investigational Site Number 156029

    Jinan, 250013

  • Investigational Site Number 156019

    Nanjing, 210008

  • Investigational Site Number 156020

    Nanjing, 210011

  • Investigational Site Number 156018

    Qingdao, 266003

  • Investigational Site Number 156028

    Shanghai, 200003

  • Investigational Site Number 156007

    Shanghai, 200072

  • Investigational Site Number 156032

    Shenyang, 110022

  • Investigational Site Number 156009

    Shijiazhuang, 050051

  • Investigational Site Number 156036

    Siping, 136000

  • Investigational Site Number 156010

    Suzhou, 215004

  • Investigational Site Number 156008

    Tianjin, 300052

  • Investigational Site Number 156027

    Wuhan, 430030

  • Investigational Site Number 156011

    Xi'an, 710032

  • Investigational Site Number 156012

    Xi'an, 710061

Other trials in China

India10 sites

  • Investigational Site Number 356019

    Ahmedabad, 380008

  • Investigational Site Number 356018

    Aligarh, 202 002

  • Investigational Site Number 356026

    Bangalore, 560092

  • Investigational Site Number 356017

    Bhubaneswar, 751005

  • Investigational Site Number 356002

    Hyderabad, 500004

  • Investigational Site Number 356024

    Hyderabad, 500063

  • Investigational Site Number 356015

    Nagpur, 440012

  • Investigational Site Number 356008

    Pune, 411001

  • Investigational Site Number 356021

    Secunderabad, 500003

  • Investigational Site Number 356023

    Visakhapatnam, 530002

Other trials in India

South Korea6 sites

  • Investigational Site Number 410003

    Daegu, 705-703

  • Investigational Site Number 410007

    Goyang, 411-706

  • Investigational Site Number 410006

    Seoul, 130-872

  • Investigational Site Number 410001

    Seoul, 136-705

  • Investigational Site Number 410005

    Seoul, 139-872

  • Investigational Site Number 410002

    Wŏnju, 220-701

Other trials in South Korea

Russia5 sites

  • Investigational Site Number 643007

    Kirov, 610014

  • Investigational Site Number 643003

    Saint Petersburg, 194354

  • Investigational Site Number 643004

    Saint Petersburg, 194354

  • Investigational Site Number 643005

    Saint Petersburg, 195112

  • Investigational Site Number 643006

    Samara, 443067

Other trials in Russia

About this study

Official title: 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.
Read more

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.
Read the 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)

Being tested
Lixisenatide (AVE0010), Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lixisenatide (AVE0010)Drug

    Pharmaceutical form:solution

    Route of administration: subcutaneous injection

  • PlaceboDrug

    Pharmaceutical form:solution

    Route of administration: subcutaneous injection

Study groups in NCT01632163
Study groupRoleWhat they receive
LixisenatideExperimental24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Receives: Drug: Lixisenatide (AVE0010)
PlaceboPlacebo comparator24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Measured: from baseline to week 24

Secondary outcomes (8)

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

    Measured: at week 24

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

    Measured: from baseline to week 24

  3. Change in fasting plasma glucose

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

  5. Change in body weight

    Measured: from baseline to week 24

  6. Change in daily basal insulin dose

    Measured: from baseline to week 24

  7. Number of patients with adverse events

    Measured: 24 weeks

  8. Anti-lixisenatide antibody assessment

    Measured: from baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632163
Sponsor's protocol ID
EFC12382
Other IDs
U1111-1124-1213
Status last verified
Jun 2015
First submitted
26 Jun 2012
Last updated
15 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21.

    PubMed 36809495

  • Yang W, Min K, Zhou Z, Li L, Xu X, Zhu D, Venkateshwar Rao A, Murthy LS, Zhang N, Li I, Niemoeller E, Shang S. 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. Diabetes Obes Metab. 2018 Feb;20(2):335-343. doi: 10.1111/dom.13072. Epub 2017 Oct 5.

    PubMed 28742225

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010) in people with Type 2 Diabetes Mellitus, run by Sanofi at 51 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China, India, South Korea, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: from baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632163, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.

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