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Type 2 Diabetes MellitusPhase 3NCT01517412

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

A Phase 3 study testing Lixisenatide (AVE0010), Self-injector pen device (OptiClik®) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 82 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

Primary Objective: To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: To assess the effect of the 2 lixisenatide regimens on: The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24… 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), Self-injector pen device (OptiClik®) and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
82 sitesin 10 countries
Study dates
Feb 2012to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
  • Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Who cannot join

  • Screening HbA1c < 7.0% and > 10.0%
  • Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
  • Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
  • Participants who usually did not eat breakfast
  • Type 1 diabetes mellitus
  • Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2
Show all 15Show fewer
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
  • Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
  • Alanine aminotransferase (ALT) > 3 ULN at screening
  • Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
  • Any contra-indication related to metformin
  • Any previous treatment with lixisenatide
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

82 sites in 10 countries.

82 sites in 10 countries

United States17 sites

  • Investigational Site Number 840115

    Billings, Montana, 59103

  • Investigational Site Number 840122

    Chicago, Illinois, 60611

  • Investigational Site Number 840119

    Chicago, Illinois, 60616

  • Investigational Site Number 840111

    Fargo, North Dakota, 58103

  • Investigational Site Number 840120

    Flint, Michigan, 48504

  • Investigational Site Number 840112

    Glendale, Arizona, 85306

  • Investigational Site Number 840113

    Mesa, Arizona, 85213

  • Investigational Site Number 840116

    Mission Viejo, California, 92691

  • Investigational Site Number 840103

    Northridge, California, 91325

  • Investigational Site Number 840105

    Phoenix, Arizona, 85028

  • Investigational Site Number 840118

    Redlands, California, 92374

  • Investigational Site Number 840101

    Sea Girt, New Jersey, 08750

  • Investigational Site Number 840114

    Springfield, Illinois, 62704

  • Investigational Site Number 840104

    Temecula, California, 92591

  • Investigational Site Number 840102

    Tempe, Arizona, 85282

  • Investigational Site Number 840107

    Tempe, Arizona

  • Investigational Site Number 840110

    West Jordan, Utah, 84088

Other trials in United States

Canada11 sites

  • Investigational Site Number 124102

    Brampton, L6R 3J5

  • Investigational Site Number 124108

    Coquitlam, V3K 3P4

  • Investigational Site Number 124106

    Etobicoke, M9R 4E1

  • Investigational Site Number 124113

    Kelowna, V1Y 1Z9

  • Investigational Site Number 124110

    Laval, H7T 2P5

  • Investigational Site Number 124103

    Newmarket, L3Y 5G8

  • Investigational Site Number 124101

    Oakville, L6H 3P1

  • Investigational Site Number 124111

    Saint Romuald, G6W 5M6

  • Investigational Site Number 124104

    Thornhill, L4J 8L7

  • Investigational Site Number 124105

    Toronto, M9V 4B4

  • Investigational Site Number 124112

    Vancouver, V5Z 1M9

Other trials in Canada

Russia9 sites

  • Investigational Site Number 643103

    Moscow, 119435

  • Investigational Site Number 643101

    Moscow, 125367

  • Investigational Site Number 643106

    Nizhny Novgorod, 603018

  • Investigational Site Number 643107

    Saint Petersburg, 194291

  • Investigational Site Number 643105

    Saint Petersburg, 194354

  • Investigational Site Number 643110

    Saint Petersburg, 195257

  • Investigational Site Number 643102

    Samara, 443067

  • Investigational Site Number 643108

    Vladimir, 600023

  • Investigational Site Number 643104

    Voronezh, 394018

Other trials in Russia

Poland8 sites

  • Investigational Site Number 616106

    Bytom, 41-902

  • Investigational Site Number 616102

    Gdansk, 80-858

  • Investigational Site Number 616101

    Krakow, 31-450

  • Investigational Site Number 616103

    Lublin, 20-538

  • Investigational Site Number 616108

    Oświęcim, 32-600

  • Investigational Site Number 616105

    Wroclaw, 50-127

  • Investigational Site Number 616104

    Wroclaw, 50-306

  • Investigational Site Number 616107

    Wroclaw, 50-403

Other trials in Poland

Spain8 sites

  • Investigational Site Number 724107

    A Coruña, 15006

  • Investigational Site Number 724104

    Barcelona, 08020

  • Investigational Site Number 724103

    Barcelona, 08041

  • Investigational Site Number 724102

    Ferrol, 15403

  • Investigational Site Number 724101

    Hostalets de Balenyà, 08550

  • Investigational Site Number 724106

    Málaga, 29010

  • Investigational Site Number 724108

    Segovia, 40002

  • Investigational Site Number 724105

    Seville, 41014

Other trials in Spain

Germany7 sites

  • Investigational Site Number 276103

    Aßlar, 35614

  • Investigational Site Number 276102

    Bad Mergentheim, 97980

  • Investigational Site Number 276107

    Berlin, 13125

  • Investigational Site Number 276101

    Heidelberg, 69115

  • Investigational Site Number 276104

    Künzing, 94550

  • Investigational Site Number 276105

    Pirna, 01796

  • Investigational Site Number 276108

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Ukraine7 sites

  • Investigational Site Number 804108

    Kharkiv, 61002

  • Investigational Site Number 804105

    Kharkiv, 61022

  • Investigational Site Number 804102

    Kiev, 2091

  • Investigational Site Number 804103

    Kyiv, 04114

  • Investigational Site Number 804104

    Mykolaiv, 54003

  • Investigational Site Number 804106

    Poltava, 36011

  • Investigational Site Number 804101

    Zaporozhie, 69600

Other trials in Ukraine

Czechia6 sites

  • Investigational Site Number 203104

    Pilsen, 32600

  • Investigational Site Number 203102

    Prague, 10000

  • Investigational Site Number 203101

    Prague, 10034

  • Investigational Site Number 203105

    Prague, 12808

  • Investigational Site Number 203103

    Trutnov, 54101

  • Investigational Site Number 203106

    Újezd u Brna, 664 53

Other trials in Czechia

Romania5 sites

  • Investigational Site Number 642101

    Bucharest, 050538

  • Investigational Site Number 642105

    Oradea, 410169

  • Investigational Site Number 642102

    Ploieşti, 100097

  • Investigational Site Number 642104

    Reşiţa, 320076

  • Investigational Site Number 642103

    Timișoara, 300456

Other trials in Romania

France4 sites

  • Investigational Site Number 250108

    Clermont-Ferrand, 63000

  • Investigational Site Number 250102

    Menton, 06500

  • Investigational Site Number 250103

    Nanterre, 92014

  • Investigational Site Number 250105

    Rennes, 35700

Other trials in France

About this study

Official title: A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Primary Objective:

  • To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

  • To assess the effect of the 2 lixisenatide regimens on:
  • The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
  • Fasting Plasma Glucose (FPG)
  • 7-point Self-Monitored Plasma Glucose (SMPG) profiles
  • Body weight
  • To assess the safety and tolerability of the 2 lixisenatide regimens
Read the detailed description

The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Being tested
Lixisenatide (AVE0010), Self-injector pen device (OptiClik®), Metformin
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 for injection; Route of administration: Subcutaneous

  • Self-injector pen device (OptiClik®)Device

  • MetforminDrug

    Also called Route of administration: Oral

    To be kept at stable dose (≥1.5 g/day) throughout the study.

Study groups in NCT01517412
Study groupRoleWhat they receive
Lixisenatide Main MealExperimentalLixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Receives: Drug: Lixisenatide (AVE0010); Device: Self-injector pen device (OptiClik®); Drug: Metformin
Lixisenatide BreakfastActive comparatorLixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Receives: Drug: Lixisenatide (AVE0010); Device: Self-injector pen device (OptiClik®); Drug: Metformin

What is being measured

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

  1. Change in HbA1c From Baseline to Week 24

    Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

    Measured: Baseline, Week 24

Secondary outcomes (9)

  1. Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24

    Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

    Measured: Week 24

  2. Change in Average 7-point SMPG Profiles From Baseline to Week 24

    Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.

    Measured: Baseline, Week 24

  3. Change in FPG From Baseline to Week 24

    Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.

    Measured: Baseline, Week 24

  4. Change in Body Weight From Baseline to Week 24

    Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.

    Measured: Baseline, Week 24

  5. Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period

    Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.

    Measured: Week 24

  6. Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24

    Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.

    Measured: Week 24

  7. Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period

    Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.

    Measured: Week 24

  8. Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24

    On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.

    Measured: Week 24

  9. Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24

    DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.

    Measured: Baseline, 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 posted25 Jan 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionMay 2013
  4. Study completionMay 2013

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
None (open label)
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01517412
Sponsor's protocol ID
EFC12261
Other IDs
2011-002416-85, U1111-1118-0841
Status last verified
Aug 2016
First submitted
16 Jan 2012
Last updated
14 Oct 2016
Data monitoring committee
Yes

Publications

  • Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

    PubMed 25012990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010), Self-injector pen device (OptiClik®) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 82 sites in 10 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 2 inclusion and 15 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada, Russia, Poland, Spain and 5 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 14 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Week 24 (time frame: Baseline, 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 NCT01517412, which also lists 1 linked publication.

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 14 Oct 2016.

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