AzTrials
AzTrials

Type 2 DiabetesPhase 3LixiLan-ONCT02058147

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

A Phase 3 study testing Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901) and Lixisenatide (AVE0010) in people with Type 2 Diabetes, run by Sanofi at 273 sites in 23 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 insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901) and Lixisenatide (AVE0010)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,170 participants
Where
273 sitesin 23 countries
Study dates
Feb 2014to Jun 2015
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 the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment.
  • Signed written informed consent.

Who cannot join

  • HbA1c at screening visit:
  • less than 7.5% or more than 10% for participants previously treated with metformin alone,
  • less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
  • Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
Show all 24Show fewer
  • History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
  • Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
  • Any contraindication to metformin use, according to local labeling.
  • Use of weight loss drugs within 3 months prior to screening visit.
  • Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
  • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
  • At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.
  • At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
  • At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
  • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).
  • Exclusion Criteria for randomization at the end of the screening period:
  • HbA1c less than 7% or above 10%;
  • Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
  • Metformin maximal tolerated dose less than 1500 mg/day;
  • Amylase and/or lipase more than 3 ULN.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

273 sites in 23 countries.

273 sites in 23 countries

United States118 sites

  • Investigational Site Number 840011

    Albuquerque, New Mexico, 87131

  • Investigational Site Number 840100

    Anaheim, California, 92801

  • Investigational Site Number 840058

    Anderson, South Carolina, 29621

  • Investigational Site Number 840075

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840039

    Asheville, North Carolina, 28803

  • Investigational Site Number 840089

    Atlanta, Georgia, 30322

  • Investigational Site Number 840097

    Auburn, Maine, 04210

  • Investigational Site Number 840059

    Aurora, Colorado, 80045

  • Investigational Site Number 840051

    Austin, Texas, 78758

  • Investigational Site Number 840008

    Avon, Indiana, 46123

  • Investigational Site Number 840015

    Avon, Indiana, 46123

  • Investigational Site Number 840076

    Avon, Indiana, 46123

  • Investigational Site Number 840065

    Bell Gardens, California, 90201

  • Investigational Site Number 840028

    Bloomfield Hills, Michigan

  • Investigational Site Number 840104

    Bradenton, Florida, 34208

  • Investigational Site Number 840112

    Bristol, Tennessee, 37620

  • Investigational Site Number 840057

    Butte, Montana, 59701

  • Investigational Site Number 840127

    Charleston, South Carolina, 29407

  • Investigational Site Number 840040

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840071

    Chesterfield, Michigan, 48047

  • Investigational Site Number 840024

    Chesterfield, Missouri, 63017

  • Investigational Site Number 840080

    Chicago, Illinois, 60607

  • Investigational Site Number 840026

    Chicago, Illinois, 60612

  • Investigational Site Number 840116

    Chicago, Illinois, 60616

  • Investigational Site Number 840090

    Chino, California, 91710

  • Investigational Site Number 840002

    Chula Vista, California, 91911

  • Investigational Site Number 840004

    Columbus, Ohio, 43213

  • Investigational Site Number 840013

    Concord, California, 94520

  • Investigational Site Number 840066

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840111

    Dallas, Texas, 75208

  • Investigational Site Number 840020

    Dallas, Texas, 75216

  • Investigational Site Number 840064

    Dallas, Texas, 75230

  • Investigational Site Number 840003

    Dallas, Texas, 75231

  • Investigational Site Number 840001

    Dearborn, Michigan, 48124

  • Investigational Site Number 840038

    Denver, Colorado, 80246

  • Investigational Site Number 840037

    Draper, Utah, 84020

  • Investigational Site Number 840088

    Edinburg, Texas, 78539

  • Investigational Site Number 840103

    Eugene, Oregon, 97404

  • Investigational Site Number 840082

    Evansville, Indiana, 47713

  • Investigational Site Number 840031

    Evansville, Indiana, 47714

  • Investigational Site Number 840060

    Evansville, Indiana, 47714

  • Investigational Site Number 840077

    Federal Way, Washington, 98003

  • Investigational Site Number 840118

    Fort Worth, Texas, 76132

  • Investigational Site Number 840053

    Fresno, California, 93720

  • Investigational Site Number 840049

    Greer, South Carolina, 29651

  • Investigational Site Number 840109

    Henderson, Nevada, 89052

  • Investigational Site Number 840021

    Hickory, North Carolina, 28601

  • Investigational Site Number 840055

    Houston, Texas, 77004

  • Investigational Site Number 840087

    Houston, Texas, 77030

  • Investigational Site Number 840079

    Hurst, Texas, 76054

  • Investigational Site Number 840108

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840048

    Indianapolis, Indiana, 46202

  • Investigational Site Number 840085

    Indianapolis, Indiana, 46260

  • Investigational Site Number 840091

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 840094

    Knoxville, Tennessee, 37912

  • Investigational Site Number 840017

    La Jolla, California, 92037

  • Investigational Site Number 840070

    Lancaster, California, 93534

  • Investigational Site Number 840052

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840054

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 840022

    Lexington, Kentucky, 40504

  • Investigational Site Number 840084

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840121

    Long Beach, California, 90806

  • Investigational Site Number 840126

    Los Angeles, California, 90017

  • Investigational Site Number 840044

    Los Angeles, California, 90057

  • Investigational Site Number 840007

    Louisville, Kentucky, 40213

  • Investigational Site Number 840016

    Maumee, Ohio, 43537

  • Investigational Site Number 840098

    Miami, Florida, 33156-7563

  • Investigational Site Number 840033

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840009

    Minneapolis, Minnesota, 55416

  • Investigational Site Number 840101

    Mission Hills, California, 91345

  • Investigational Site Number 840086

    Mission Viejo, California, 92691

  • Investigational Site Number 840120

    Mission Viejo, California, 92691

  • Investigational Site Number 840046

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840072

    Morganton, North Carolina, 28655

  • Investigational Site Number 840123

    Morganville, New Jersey, 07751

  • Investigational Site Number 840073

    N Richland Hill, Texas, 76180

  • Investigational Site Number 840069

    Nashua, New Hampshire, 03063

  • Investigational Site Number 840030

    New Hyde Park, New York, 11042

  • Investigational Site Number 840081

    New Orleans, Louisiana, 70112

  • Investigational Site Number 840014

    New Port Richey, Florida, 34652

  • Investigational Site Number 840045

    Norfolk, Virginia, 23510

  • Investigational Site Number 840092

    Norfolk, Virginia, 23510

  • Investigational Site Number 840005

    Northridge, California, 91325

  • Investigational Site Number 840047

    Ocoee, Florida, 34761

  • Investigational Site Number 840093

    Ogden, Utah, 84405

  • Investigational Site Number 840042

    Omaha, Nebraska, 68131

  • Investigational Site Number 840056

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840034

    Palm Springs, California, 92262

  • Investigational Site Number 840027

    Phoenix, Arizona, 85028

  • Investigational Site Number 840122

    Phoenix, Arizona, 85032

  • Investigational Site Number 840036

    Pittsburgh, Pennsylvania, 15473

  • Investigational Site Number 840074

    Port Hueneme, California, 93041

  • Investigational Site Number 840113

    Portland, Oregon, 97201-3098

  • Investigational Site Number 840114

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840102

    Renton, Washington, 98055

  • Investigational Site Number 840125

    Richmond, Virginia, 23219

  • Investigational Site Number 840063

    Rockville, Maryland, 20852

  • Investigational Site Number 840115

    Salem, Virginia, 24153

  • Investigational Site Number 840110

    Salisbury, North Carolina, 28144

  • Investigational Site Number 840061

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840041

    Salt Lake City, Utah, 84107

  • Investigational Site Number 840019

    San Antonio, Texas, 78229

  • Investigational Site Number 840068

    San Ramon, California, 94583

  • Investigational Site Number 840067

    Santa Ana, California, 92704

  • Investigational Site Number 840050

    Springfield, Illinois, 62704

  • Investigational Site Number 840096

    Syracuse, New York, 13214-2016

  • Investigational Site Number 840029

    Tarzana, California, 91356

  • Investigational Site Number 840006

    Temecula, California, 92591

  • Investigational Site Number 840062

    Tempe, Arizona, 85282

  • Investigational Site Number 840023

    Tempe, Arizona

  • Investigational Site Number 840043

    Tipton, Pennsylvania, 16684

  • Investigational Site Number 840012

    Valparaiso, Indiana

  • Investigational Site Number 840025

    Waterloo, Iowa, 50702

  • Investigational Site Number 840010

    Weber City, Virginia, 24290

  • Investigational Site Number 840078

    West Hills, California, 91345

  • Investigational Site Number 840095

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840099

    Winston-Salem, North Carolina, 27103

  • Investigational Site Number 840119

    Woodstock, Georgia, 30189

Other trials in United States

Czechia13 sites

  • Investigational Site Number 203004

    Beroun, 26601

  • Investigational Site Number 203008

    České Budějovice, 370 01

  • Investigational Site Number 203014

    Hořovice, 26801

  • Investigational Site Number 203012

    Kopřivnice, 742 21

  • Investigational Site Number 203001

    Pardubice, 53002

  • Investigational Site Number 203005

    Pilsen, 32600

  • Investigational Site Number 203003

    Prague, 100 00

  • Investigational Site Number 203009

    Prague, 12808

  • Investigational Site Number 203007

    Prague, 15000

  • Investigational Site Number 203013

    Praha 9 - Klanovice, 19014

  • Investigational Site Number 203006

    Trutnov, 54101

  • Investigational Site Number 203016

    Újezd u Brna

  • Investigational Site Number 203015

    Vsetín, 75501

Other trials in Czechia

Russia13 sites

  • Investigational Site Number 643006

    Moscow, 119991

  • Investigational Site Number 643008

    Penza, 440026

  • Investigational Site Number 643012

    Petrozavodsk, 185019

  • Investigational Site Number 643001

    Saint Petersburg, 190013

  • Investigational Site Number 643005

    Saint Petersburg, 190068

  • Investigational Site Number 643007

    Saint Petersburg, 194354

  • Investigational Site Number 643003

    Saint Petersburg, 194358

  • Investigational Site Number 643002

    Saint Petersburg, 195257

  • Investigational Site Number 643014

    Samara, 443067

  • Investigational Site Number 643009

    Saratov, 410026

  • Investigational Site Number 643011

    Saratov, 410053

  • Investigational Site Number 643016

    Tomsk, 634050

  • Investigational Site Number 643004

    Voronezh, 394018

Other trials in Russia

Chile11 sites

  • Investigational Site Number 152008

    Osorno, 5311092

  • Investigational Site Number 152015

    Puerto Varas

  • Investigational Site Number 152004

    Santiago, 7500010

  • Investigational Site Number 152006

    Santiago, 7500010

  • Investigational Site Number 152001

    Santiago, 7591047

  • Investigational Site Number 152002

    Santiago, 7980378

  • Investigational Site Number 152012

    Santiago, 8053095

  • Investigational Site Number 152009

    Santiago, 8330008

  • Investigational Site Number 152011

    Talagante

  • Investigational Site Number 152014

    Temuco, 4781156

  • Investigational Site Number 152003

    Temuco, 4813299

Other trials in Chile

Spain11 sites

  • Investigational Site Number 724011

    A Coruña, 15006

  • Investigational Site Number 724012

    Barcelona, 08003

  • Investigational Site Number 724009

    Granada, 18012

  • Investigational Site Number 724004

    Hostalets de Balenyà, 08550

  • Investigational Site Number 724007

    Lugo, 27004

  • Investigational Site Number 724008

    Madrid, 28034

  • Investigational Site Number 724005

    Madrid, 28046

  • Investigational Site Number 724013

    Palma de Mallorca, 07010

  • Investigational Site Number 724001

    Quart de Poblet, 46930

  • Investigational Site Number 724006

    Sant Joan Despí, 08970

  • Investigational Site Number 724003

    Seville, 41010

Other trials in Spain

Hungary10 sites

  • Investigational Site Number 348003

    Balatonfüred, 8230

  • Investigational Site Number 348007

    Budapest, 1036

  • Investigational Site Number 348006

    Budapest, 1096

  • Investigational Site Number 348002

    Budapest, 1138

  • Investigational Site Number 348011

    Komárom, 2900

  • Investigational Site Number 348008

    Nagykanizsa, 8800

  • Investigational Site Number 348012

    Sátoraljaújhely, 3980

  • Investigational Site Number 348004

    Szeged, 6720

  • Investigational Site Number 348010

    Székesfehérvár, 8000

  • Investigational Site Number 348001

    Zalaegerszeg, 8900

Other trials in Hungary

Romania9 sites

  • Investigational Site Number 642008

    Bucharest, 010825

  • Investigational Site Number 642007

    Bucharest, 020475

  • Investigational Site Number 642009

    Cluj-Napoca, 400006

  • Investigational Site Number 642006

    Hunedoara, 331057

  • Investigational Site Number 642005

    Iași, 700547

  • Investigational Site Number 642002

    Oradea, 410169

  • Investigational Site Number 642001

    Târgu Mureş, 540142

  • Investigational Site Number 642004

    Timișoara, 300133

  • Investigational Site Number 642003

    Timișoara, 300456

Other trials in Romania

Mexico8 sites

  • Investigational Site Number 484005

    Aguascalientes, 20230

  • Investigational Site Number 484001

    Cuernavaca, 62250

  • Investigational Site Number 484002

    Guadalajara, 44130

  • Investigational Site Number 484004

    Guadalajara, 44210

  • Investigational Site Number 484009

    Guadalajara, 44670

  • Investigational Site Number 484007

    Monterrey, 64020

  • Investigational Site Number 484006

    Monterrey, 64460

  • Investigational Site Number 484010

    Zapopan, 45116

Other trials in Mexico

Poland8 sites

  • Investigational Site Number 616002

    Bialystok, 15-435

  • Investigational Site Number 616005

    Krakow, 31-261

  • Investigational Site Number 616006

    Krakow, 31-548

  • Investigational Site Number 616007

    Lodz, 94-074

  • Investigational Site Number 616004

    Szczecin, 70-506

  • Investigational Site Number 616003

    Warsaw, 01-518

  • Investigational Site Number 616001

    Warsaw, 02-507

  • Investigational Site Number 616008

    Żory, 44-240

Other trials in Poland

Ukraine8 sites

  • Investigational Site Number 804002

    Chernivtsi, 58022

  • Investigational Site Number 804009

    Ivano-Frankivsk, 76008

  • Investigational Site Number 804010

    Kyiv, 03049

  • Investigational Site Number 804007

    Kyiv, 04050

  • Investigational Site Number 804006

    Kyiv

  • Investigational Site Number 804012

    Lviv, 79010

  • Investigational Site Number 804011

    Vinnytsia, 21001

  • Investigational Site Number 804008

    Vinnytsia, 21010

Other trials in Ukraine

Germany7 sites

  • Investigational Site Number 276005

    Berlin, 10115

  • Investigational Site Number 276003

    Berlin, 13125

  • Investigational Site Number 276004

    Dortmund, 44137

  • Investigational Site Number 276007

    Dresden, 01069

  • Investigational Site Number 276001

    Dresden, 01307

  • Investigational Site Number 276006

    Hamburg, 20253

  • Investigational Site Number 276002

    Neumünster, 24534

Other trials in Germany

Lithuania7 sites

  • Investigational Site Number 440003

    Jonava, LT-55201

  • Investigational Site Number 440002

    Kaunas, LT-49456

  • Investigational Site Number 440007

    Kaunas, LT-50009

  • Investigational Site Number 440004

    Kėdainiai, LT-57164

  • Investigational Site Number 440006

    Panevezys, LT-37355

  • Investigational Site Number 440005

    Utena, LT-28151

  • Investigational Site Number 440001

    Vilnius, LT-10323

Other trials in Lithuania

South Africa7 sites

  • Investigational Site Number 710002

    Cap Town, 7530

  • Investigational Site Number 710003

    Cape Town, 7500

  • Investigational Site Number 710005

    Meyerspark, 0184

  • Investigational Site Number 710007

    Port Elizabeth

  • Investigational Site Number 710004

    Pretoria, 0122

  • Investigational Site Number 710001

    Somerset West, 7130

  • Investigational Site Number 710006

    Soweto, 4309

Other trials in South Africa

Denmark6 sites

  • Investigational Site Number 208003

    Aarhus C, 8000

  • Investigational Site Number 208009

    Horsens, 8700

  • Investigational Site Number 208001

    København NV, 2400

  • Investigational Site Number 208005

    København S, 2300

  • Investigational Site Number 208002

    Kolding, 6000

  • Investigational Site Number 208004

    Viborg, 8800

Other trials in Denmark

Italy5 sites

  • Investigational Site Number 380002

    Bologna, 40138

  • Investigational Site Number 380006

    Catanzaro, 88100

  • Investigational Site Number 380001

    Milan, 20132

  • Investigational Site Number 380003

    Naples, 80131

  • Investigational Site Number 380005

    Roma, 00133

Other trials in Italy

Sweden5 sites

  • Investigational Site Number 752001

    Ljungby, 341 82

  • Investigational Site Number 752003

    Malmö, 211 52

  • Investigational Site Number 752004

    Rättvik, 79530

  • Investigational Site Number 752005

    Stockholm, 11526

  • Investigational Site Number 752002

    Vällingby, 16268

Other trials in Sweden

United Kingdom5 sites

  • Investigational Site Number 826001

    Coventry, CV2 2DX

  • Investigational Site Number 826002

    Dundee, DD1 9SI

  • Investigational Site Number 826006

    Guildford, GU2 7XX

  • Investigational Site Number 826007

    Leicester, LE5 4PW

  • Investigational Site Number 826003

    Norwich, NR1 3SR

Other trials in United Kingdom

Australia4 sites

  • Investigational Site Number 036005

    Box Hill, 3128

  • Investigational Site Number 036001

    Camperdown, 2050

  • Investigational Site Number 036006

    Kippa-Ring, 4021

  • Investigational Site Number 036007

    Logan Central, 4114

Other trials in Australia

Estonia4 sites

  • Investigational Site Number 233004

    Paide, 72713

  • Investigational Site Number 233002

    Pärnu, 80018

  • Investigational Site Number 233003

    Tallinn, 13415

  • Investigational Site Number 233001

    Viljandimaa, 71024

Other trials in Estonia

France4 sites

  • Investigational Site Number 250006

    Corbeil-Essonnes, 91109

  • Investigational Site Number 250002

    La Rochelle, 17019

  • Investigational Site Number 250003

    Pierre-Bénite, 69310

  • Investigational Site Number 250001

    Vénissieux, 69200

Other trials in France

Latvia4 sites

  • Investigational Site Number 428002

    Riga, LV-1011

  • Investigational Site Number 428003

    Riga, LV-1011

  • Investigational Site Number 428004

    Riga, LV-1050

  • Investigational Site Number 428001

    Sigulda, LV-2150

Other trials in Latvia

Belgium3 sites

  • Investigational Site Number 056005

    Brussels, 1070

  • Investigational Site Number 056006

    Brussels, 1090

  • Investigational Site Number 056001

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • Investigational Site Number 124004

    Kelowna, V1Y 1Z9

  • Investigational Site Number 124001

    Toronto, M4G 3E8

  • Investigational Site Number 124002

    Vancouver, V5Z 1M9

Other trials in Canada

About this study

Official title: A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Primary Objective:

To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

Read the detailed description

Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Conditions
Type 2 Diabetes
Being tested
Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901), Lixisenatide (AVE0010), 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.

  • Insulin glargine/lixisenatide Fixed Ratio CombinationDrug

    Also called (HOE901/AVE0010)

    Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.

  • Insulin glargine (HOE901)Drug

    Also called Lantus

    Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.

  • Lixisenatide (AVE0010)Drug

    Also called Lyxumia

    Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.

  • MetforminDrug

    Pharmaceutical form: Tablet; Route of administration: Oral administration.

Study groups in NCT02058147
Study groupRoleWhat they receive
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)ExperimentalFRC once daily (QD) for 30 weeks. Dose individually adjusted.
Receives: Drug: Insulin glargine/lixisenatide Fixed Ratio Combination; Drug: Metformin
Insulin GlargineActive comparatorInsulin glargine QD for 30 weeks. Dose individually adjusted.
Receives: Drug: Insulin glargine (HOE901); Drug: Metformin
LixisenatideActive comparatorLixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).
Receives: Drug: Lixisenatide (AVE0010); 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 30

    Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.

    Change in HbA1c was calculated by subtracting baseline value from Week 30 value.

    Measured: Baseline, Week 30

Secondary outcomes (14)

  1. Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30

    Participants without Week 30 value for HbA1c were counted as non-responders.

    Measured: Week 30

  2. Change in Plasma Glucose Excursion From Baseline to Week 30

    Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).

    Measured: Baseline, Week 30

  3. Change in Body Weight From Baseline to Week 30

    Change in body weight was calculated by subtracting baseline value from Week 30 value.

    Measured: Baseline, Week 30

  4. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30

    Change in FPG was calculated by subtracting baseline value from Week 30 value.

    Measured: Baseline, Week 30

  5. Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30

    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 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.

    Measured: Baseline, Week 30

  6. Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30

    Measured: Week 30

  7. Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

    Measured: Baseline up to Week 30

  8. Average Daily Insulin Glargine Dose at Week 30

    The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.

    Measured: Week 30

  9. Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30

    The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.

    Measured: Baseline, Week 30

  10. Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.

    Measured: Baseline up to Week 30

  11. Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period

    Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.

    Measured: Baseline up to Week 30

  12. Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

    Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).

    Measured: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

  13. Percentage of Participants With Documented Symptomatic Hypoglycemia

    Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).

    Measured: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

  14. Percentage of Participants With Severe Symptomatic Hypoglycemia

    Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others.

    Measured: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

Timeline

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

  1. First posted7 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 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
None (open label)
Enrolment
1,170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02058147
Sponsor's protocol ID
EFC12404
Other IDs
2013-003131-30, U1111-1148-4334
Acronym
LixiLan-O
Status last verified
Mar 2017
First submitted
6 Feb 2014
Last updated
9 May 2017
Data monitoring committee
Yes

Publications

  • Rosenstock J, Aronson R, Grunberger G, Hanefeld M, Piatti P, Serusclat P, Cheng X, Zhou T, Niemoeller E, Souhami E, Davies M; LixiLan-O Trial Investigators. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016 Nov;39(11):2026-2035. doi: 10.2337/dc16-0917. Epub 2016 Aug 15.

    PubMed 27527848

  • Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.

    PubMed 35101326

  • Davies MJ, Russell-Jones D, Barber TM, Lavalle-Gonzalez FJ, Galstyan GR, Zhu D, Baxter M, Dessapt-Baradez C, McCrimmon RJ. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):1967-1972. doi: 10.1111/dom.13791. Epub 2019 Jun 18.

    PubMed 31124299

  • Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019 Mar 21;7(1):e000581. doi: 10.1136/bmjdrc-2018-000581. eCollection 2019.

    PubMed 31114694

  • Schmider W, Belder R, Lee M, Niemoeller E, Souhami E, Frias JP. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. Curr Med Res Opin. 2019 Jun;35(6):1081-1089. doi: 10.1080/03007995.2018.1558852. Epub 2019 Jan 11.

    PubMed 30550345

  • Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

    PubMed 29974618

  • Trujillo JM, Roberts M, Dex T, Chao J, White J, LaSalle J. Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone. Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 Aug 21.

    PubMed 29923298

  • Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J. Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents. Diabetes Obes Metab. 2017 Dec;19(12):1798-1804. doi: 10.1111/dom.12980. Epub 2017 Jul 7.

    PubMed 28432746

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901) and Lixisenatide (AVE0010) in people with Type 2 Diabetes, run by Sanofi at 273 sites in 23 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 24 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in United States, Czechia, Russia, Chile, Spain and 18 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 10 Feb 2017). 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 30 (time frame: Baseline, Week 30). 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 NCT02058147, which also lists 8 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 9 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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