AzTrials
AzTrials

Type 2 DiabetesPhase 3LixiLan-LNCT02058160

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

A Phase 3 study testing Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Metformin (Background Drug) in people with Type 2 Diabetes, run by Sanofi at 236 sites in 18 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 demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine 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 (HOE901/AVE0010), Insulin glargine (HOE901) and Metformin (Background Drug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
736 participants
Where
236 sitesin 18 countries
Study dates
Jan 2014to Jul 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

  • Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
  • Treatment with basal insulin for at least 6 months before the screening visit.
  • Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
  • Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
  • For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of:
  • metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
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  • a sulfonylurea,
  • a glinide,
  • a dipeptidyl-peptidase-4 inhibitor,
  • a sodium glucose co-transporter 2 inhibitor,
  • Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.
  • Signed written informed consent.

Who cannot join

  • Age under legal age of adulthood at screening visit.
  • HbA1c at screening visit less than 7.5% or above 10%.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.
  • Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.
  • History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.
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  • Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.
  • 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 (eg, 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).
  • Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.
  • Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.
  • HbA1c less than 7% or above 10% .
  • Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
  • Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
  • 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

236 sites in 18 countries.

236 sites in 18 countries

United States108 sites

  • Investigational Site Number 840576

    Albuquerque, New Mexico, 87131

  • Investigational Site Number 840605

    Amarillo, Texas, 79106

  • Investigational Site Number 840580

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840594

    Atlanta, Georgia, 30322

  • Investigational Site Number 840582

    Aurora, Colorado, 80045

  • Investigational Site Number 840553

    Austin, Texas, 78731

  • Investigational Site Number 840598

    Austin, Texas, 78731

  • Investigational Site Number 840543

    Avon, Indiana, 46123

  • Investigational Site Number 840520

    Baltimore, Maryland, 21237

  • Investigational Site Number 840560

    Baltimore, Maryland, 21237

  • Investigational Site Number 840568

    Bell Gardens, California, 90201

  • Investigational Site Number 840607

    Birmingham, Alabama, 35205

  • Investigational Site Number 840613

    Burlington, Vermont, 05401

  • Investigational Site Number 840558

    Butte, Montana, 59701

  • Investigational Site Number 840622

    Charleston, South Carolina, 29407

  • Investigational Site Number 840504

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840519

    Chicago, Illinois, 60607

  • Investigational Site Number 840612

    Chicago, Illinois, 60616

  • Investigational Site Number 840550

    Chino, California, 91710

  • Investigational Site Number 840529

    Chula Vista, California, 91911

  • Investigational Site Number 840614

    Columbus, Georgia, 31904

  • Investigational Site Number 840579

    Columbus, Ohio, 43213

  • Investigational Site Number 840623

    Corona, California, 92879

  • Investigational Site Number 840502

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840601

    Dallas, Texas, 75208

  • Investigational Site Number 840586

    Dallas, Texas, 75216

  • Investigational Site Number 840547

    Dallas, Texas, 75230

  • Investigational Site Number 840530

    Dallas, Texas, 75231

  • Investigational Site Number 840545

    Dallas, Texas, 75246

  • Investigational Site Number 840524

    Dayton, Ohio, 45439

  • Investigational Site Number 840505

    Dearborn, Michigan, 48124

  • Investigational Site Number 840509

    Denver, Colorado, 80246

  • Investigational Site Number 840512

    Draper, Utah, 84020

  • Investigational Site Number 840541

    Durham, North Carolina, 27710

  • Investigational Site Number 840554

    Edinburg, Texas, 78539

  • Investigational Site Number 840618

    Eugene, Oregon, 97404

  • Investigational Site Number 840565

    Evansville, Indiana, 47713

  • Investigational Site Number 840585

    Evansville, Indiana, 47714

  • Investigational Site Number 840615

    Evansville, Indiana, 47714

  • Investigational Site Number 840571

    Federal Way, Washington, 98003

  • Investigational Site Number 840575

    Flint, Michigan, 48504

  • Investigational Site Number 840566

    Fresno, California, 93720

  • Investigational Site Number 840552

    Greenbrae, California, 94904

  • Investigational Site Number 840604

    Greenville, North Carolina, 27858

  • Investigational Site Number 840600

    Henderson, Nevada, 89074

  • Investigational Site Number 840540

    Hickory, North Carolina, 28601

  • Investigational Site Number 840544

    Houston, Texas, 77030

  • Investigational Site Number 840514

    Hurst, Texas, 76054

  • Investigational Site Number 840588

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840563

    Indianapolis, Indiana, 46202

  • Investigational Site Number 840507

    Indianapolis, Indiana, 46260

  • Investigational Site Number 840583

    Jamaica, New York, 11432

  • Investigational Site Number 840578

    Lancaster, California, 93534

  • Investigational Site Number 840532

    Las Vegas, Nevada, 89119

  • Investigational Site Number 840599

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840501

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 840595

    Lewiston, Maine, 04240

  • Investigational Site Number 840517

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840537

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840626

    Los Angeles, California, 90017

  • Investigational Site Number 840581

    Los Angeles, California, 90057

  • Investigational Site Number 840516

    Louisville, Kentucky, 40213

  • Investigational Site Number 840503

    Maumee, Ohio, 43537

  • Investigational Site Number 840510

    Miami, Florida, 33156-7563

  • Investigational Site Number 840546

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840564

    Minneapolis, Minnesota, 55416

  • Investigational Site Number 840621

    Mission Viejo, California, 92691

  • Investigational Site Number 840513

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840591

    Murray, Utah, 84123

  • Investigational Site Number 840617

    N Richland Hill, Texas, 76180

  • Investigational Site Number 840539

    Nashua, New Hampshire, 03063

  • Investigational Site Number 840531

    New Hyde Park, New York, 11042

  • Investigational Site Number 840521

    New Port Richey, Florida, 34652

  • Investigational Site Number 840561

    Norfolk, Virginia, 23510

  • Investigational Site Number 840625

    Norfolk, Virginia, 23510

  • Investigational Site Number 840511

    Northridge, California, 91325

  • Investigational Site Number 840602

    Ocala, Florida, 34471

  • Investigational Site Number 840538

    Ocoee, Florida, 34761

  • Investigational Site Number 840526

    Ogden, Utah, 84405

  • Investigational Site Number 840506

    Omaha, Nebraska, 68131

  • Investigational Site Number 840597

    Orem, Utah, 84058

  • Investigational Site Number 840534

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840573

    Palm Springs, California, 92262

  • Investigational Site Number 840610

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 840559

    Port Hueneme, California, 93041

  • Investigational Site Number 840611

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840606

    Richmond, Virginia, 23227

  • Investigational Site Number 840522

    Rockville, Maryland, 20852

  • Investigational Site Number 840525

    Roswell, Georgia, 30076

  • Investigational Site Number 840608

    Salem, Virginia, 24153

  • Investigational Site Number 840592

    Salisbury, North Carolina, 28144

  • Investigational Site Number 840590

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840536

    San Ramon, California, 94583

  • Investigational Site Number 840567

    Santa Ana, California, 92704

  • Investigational Site Number 840551

    Smithfield, Pennsylvania, 15478

  • Investigational Site Number 840593

    Spokane, Washington, 99220

  • Investigational Site Number 840556

    Springfield, Illinois, 62704

  • Investigational Site Number 840570

    Sun City, Arizona, 85351

  • Investigational Site Number 840557

    Syracuse, New York, 13214-2016

  • Investigational Site Number 840609

    Tacoma, Washington, 98415-0299

  • Investigational Site Number 840569

    Tarzana, California, 91356

  • Investigational Site Number 840562

    Tempe, Arizona

  • Investigational Site Number 840584

    Tipton, Pennsylvania, 16684

  • Investigational Site Number 840577

    Tucson, Arizona, 85723

  • Investigational Site Number 840572

    West Hills, California, 91345

  • Investigational Site Number 840549

    Wilmington, Delaware, 19713

  • Investigational Site Number 840535

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840515

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia13 sites

  • Investigational Site Number 643511

    Arkhangelsk, 163045

  • Investigational Site Number 643512

    Moscow, 119435

  • Investigational Site Number 643508

    Penza, 440026

  • Investigational Site Number 643501

    Saint Petersburg, 190013

  • Investigational Site Number 643506

    Saint Petersburg, 194291

  • Investigational Site Number 643503

    Saint Petersburg, 194354

  • Investigational Site Number 643504

    Saint Petersburg, 194354

  • Investigational Site Number 643505

    Saint Petersburg, 194358

  • Investigational Site Number 643502

    Saint Petersburg, 195257

  • Investigational Site Number 643513

    Samara, 443041

  • Investigational Site Number 643507

    Saratov, 410030

  • Investigational Site Number 643514

    Saratov, 410053

  • Investigational Site Number 643509

    Voronezh, 394018

Other trials in Russia

Canada11 sites

  • Investigational Site Number 124504

    Beamsville, L0R 1B0

  • Investigational Site Number 124512

    Brampton, L6R 3J5

  • Investigational Site Number 124502

    Guelph, N1H 1B1

  • Investigational Site Number 124507

    Kelowna, V1Y 1Z9

  • Investigational Site Number 124505

    Montreal, H1W 2R7

  • Investigational Site Number 124511

    Oakville, L6H 3P1

  • Investigational Site Number 124509

    Saint Romuald, G6W 5M6

  • Investigational Site Number 124503

    Toronto, M9V 4B4

  • Investigational Site Number 124510

    Toronto, M9W 4L9

  • Investigational Site Number 124501

    Vancouver, V5Y 3W2

  • Investigational Site Number 124508

    Victoria, V8V 4A1

Other trials in Canada

Czechia11 sites

  • Investigational Site Number 203502

    Cheb, 35002

  • Investigational Site Number 203504

    Hranice, 75301

  • Investigational Site Number 203507

    Krnov, 79401

  • Investigational Site Number 203506

    Liberec, 460 01

  • Investigational Site Number 203503

    Olomouc, 77900

  • Investigational Site Number 203514

    Pilsen, 301 66

  • Investigational Site Number 203515

    Pilsen, 301 66

  • Investigational Site Number 203511

    Prague, 14900

  • Investigational Site Number 203508

    Prague, 15030

  • Investigational Site Number 203509

    Prague, 18100

  • Investigational Site Number 203505

    Prostějov, 79601

Other trials in Czechia

Romania11 sites

  • Investigational Site Number 642507

    Brasov, 500365

  • Investigational Site Number 642510

    Bucharest, 010825

  • Investigational Site Number 642508

    Bucharest, 020042

  • Investigational Site Number 642509

    Bucharest, 020475

  • Investigational Site Number 642506

    Hunedoara, 331057

  • Investigational Site Number 642505

    Iași, 700547

  • Investigational Site Number 642502

    Oradea, 410169

  • Investigational Site Number 642511

    Sibiu, 550371

  • Investigational Site Number 642501

    Târgu Mureş, 540142

  • Investigational Site Number 642504

    Timișoara, 300125

  • Investigational Site Number 642503

    Timișoara, 300456

Other trials in Romania

Slovakia11 sites

  • Investigational Site Number 703505

    Bratislava, 85101

  • Investigational Site Number 703507

    Bytča, 01401

  • Investigational Site Number 703502

    Košice, 04001

  • Investigational Site Number 703512

    Košice, 04001

  • Investigational Site Number 703510

    Košice, 04013

  • Investigational Site Number 703511

    Ľubochňa, 3491

  • Investigational Site Number 703508

    Moldava nad Bodvou, 04525

  • Investigational Site Number 703504

    Nové Mesto nad Váhom, 91501

  • Investigational Site Number 703509

    Nové Zámky, 94001

  • Investigational Site Number 703513

    Trnava, 91701

  • Investigational Site Number 703501

    Žilina, 01001

Other trials in Slovakia

Spain10 sites

  • Investigational Site Number 724508

    A Coruña, 15006

  • Investigational Site Number 724509

    Alicante, 03010

  • Investigational Site Number 724506

    Alzira, 46600

  • Investigational Site Number 724504

    Barcelona, 08035

  • Investigational Site Number 724510

    Barcelona, 08036

  • Investigational Site Number 724505

    Cáceres, 10003

  • Investigational Site Number 724503

    Ferrol, 15405

  • Investigational Site Number 724501

    Sabadell, 08208

  • Investigational Site Number 724507

    Segovia, 40002

  • Investigational Site Number 724502

    Valencia, 46014

Other trials in Spain

Chile9 sites

  • Investigational Site Number 152511

    Puerto Varas, 5480000

  • Investigational Site Number 152502

    Santiago, 7500347

  • Investigational Site Number 152501

    Santiago, 7500710

  • Investigational Site Number 152514

    Santiago, 7500739

  • Investigational Site Number 152503

    Santiago, 8053095

  • Investigational Site Number 152507

    Santiago

  • Investigational Site Number 152509

    Talagante

  • Investigational Site Number 152513

    Temuco, 4780000

  • Investigational Site Number 152504

    Viña del Mar

Other trials in Chile

Mexico8 sites

  • Investigational Site Number 484508

    Celaya, 38000

  • Investigational Site Number 484501

    Cuernavaca, 62250

  • Investigational Site Number 484503

    Guadalajara, 44130

  • Investigational Site Number 484504

    Guadalajara, 44210

  • Investigational Site Number 484506

    Guadalajara, 44600

  • Investigational Site Number 484509

    México, 06700

  • Investigational Site Number 484507

    Pachuca, 42084

  • Investigational Site Number 484505

    Puebla City, 72190

Other trials in Mexico

Poland7 sites

  • Investigational Site Number 616502

    Bialystok, 15-435

  • Investigational Site Number 616505

    Krakow, 31-261

  • Investigational Site Number 616506

    Krakow, 31-548

  • Investigational Site Number 616507

    Płock, 09-400

  • Investigational Site Number 616504

    Szczecin, 70-506

  • Investigational Site Number 616503

    Warsaw, 01-518

  • Investigational Site Number 616501

    Warsaw, 02-507

Other trials in Poland

Ukraine7 sites

  • Investigational Site Number 804501

    Chernivtsi, 58022

  • Investigational Site Number 804510

    Kyiv, 03049

  • Investigational Site Number 804507

    Kyiv, 04050

  • Investigational Site Number 804511

    Kyiv

  • Investigational Site Number 804513

    Lviv, 79010

  • Investigational Site Number 804502

    Vinnytsia, 21001

  • Investigational Site Number 804508

    Vinnytsia, 21010

Other trials in Ukraine

Denmark6 sites

  • Investigational Site Number 208503

    Aarhus C, 8000

  • Investigational Site Number 208509

    Horsens, 8700

  • Investigational Site Number 208501

    København NV, 2400

  • Investigational Site Number 208505

    København S, 2300

  • Investigational Site Number 208502

    Kolding, 6000

  • Investigational Site Number 208504

    Viborg, 8800

Other trials in Denmark

Hungary6 sites

  • Investigational Site Number 348503

    Budapest, 1134

  • Investigational Site Number 348501

    Budapest, 1138

  • Investigational Site Number 348505

    Budapest, 1212

  • Investigational Site Number 348502

    Debrecen, 4031

  • Investigational Site Number 348506

    Kaposvár, 7400

  • Investigational Site Number 348504

    Pápa, 8500

Other trials in Hungary

Sweden6 sites

  • Investigational Site Number 752501

    Ljungby, 341 82

  • Investigational Site Number 752503

    Malmö, 211 52

  • Investigational Site Number 752504

    Rättvik, 79530

  • Investigational Site Number 752506

    Stenungssund, 44431

  • Investigational Site Number 752505

    Stockholm, 11526

  • Investigational Site Number 752502

    Vällingby, 16268

Other trials in Sweden

Lithuania5 sites

  • Investigational Site Number 440501

    Kaunas, 48259

  • Investigational Site Number 440503

    Kaunas, 49449

  • Investigational Site Number 440505

    Kėdainiai, LT-57164

  • Investigational Site Number 440504

    Klaipėda, LT-92253

  • Investigational Site Number 440502

    Vilnius, LT-10323

Other trials in Lithuania

Australia3 sites

  • Investigational Site Number 036505

    Box Hill, 3128

  • Investigational Site Number 036501

    Heidelberg, 3081

  • Investigational Site Number 036504

    Parkville, 3050

Other trials in Australia

Estonia3 sites

  • Investigational Site Number 233502

    Pärnu, 80018

  • Investigational Site Number 233503

    Tallinn, 10138

  • Investigational Site Number 233501

    Tartu, 50406

Other trials in Estonia

Netherlands1 site

  • Investigational Site Number 528505

    Almere Stad, 1311 RL

Other trials in Netherlands

About this study

Official title: A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

Read the detailed description

Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

Conditions
Type 2 Diabetes
Being tested
Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin (Background Drug)
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 (HOE901/AVE0010)Drug

    Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.

    Dose was adjusted weekly 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). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.

  • Insulin glargine (HOE901)Drug

    Also called Lantus

    Insulin glargine was self-administered QD by SC injection at approximately the same time every day.

    After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

  • Metformin (Background Drug)Drug

    Pharmaceutical form: Tablet; Route of administration: Oral administration

Study groups in NCT02058160
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 (HOE901/AVE0010); Drug: Metformin (Background Drug)
Insulin glargineActive comparatorInsulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.
Receives: Drug: Insulin glargine (HOE901); Drug: Metformin (Background Drug)

What is being measured

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

  1. Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30

    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

    Measured: Week 30

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

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

    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. 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

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

    Measured: Week 30

  6. Change in Daily Insulin Glargine Dose From Baseline to Week 30

    Measured: Baseline, 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. Change in FPG From Baseline to Week 30

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

    Measured: Baseline, Week 30

  9. Change in 2-hour PPG From Baseline to Week 30

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

    Measured: Baseline, Week 30

  10. Percentage of Participants Reaching HbA1c <7.0% 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).

    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) were 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 typical 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 [FRC], 210 days [Insulin glargine])

  13. Percentage of Participants With Documented Symptomatic Hypoglycemia

    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: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

  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 had 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 for 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 [FRC], 210 days [Insulin glargine])

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 startJan 2014
  3. Primary completionJul 2015
  4. Study completionJul 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
736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02058160
Sponsor's protocol ID
EFC12405
Other IDs
2013-003132-79, U1111-1148-4351
Acronym
LixiLan-L
Status last verified
Mar 2017
First submitted
6 Feb 2014
Last updated
9 May 2017
Data monitoring committee
Yes

Publications

  • Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, Gonzalez-Galvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L Trial Investigators. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20.

    PubMed 27650977

  • Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

    PubMed 31848983

  • Blonde L, Bailey TS, Chao J, Dex TA, Frias JP, Meneghini LF, Roberts M, Aroda VR. Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial. Adv Ther. 2019 Sep;36(9):2310-2326. doi: 10.1007/s12325-019-01033-1. Epub 2019 Jul 29.

    PubMed 31359368

  • 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

  • Zisman A, Dex T, Roberts M, Saremi A, Chao J, Aroda VR. Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Oct;9(5):2155-2162. doi: 10.1007/s13300-018-0507-0. Epub 2018 Sep 14.

    PubMed 30218434

  • 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

  • Niemoeller E, Souhami E, Wu Y, Jensen KH. iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Feb;9(1):373-382. doi: 10.1007/s13300-017-0336-6. Epub 2017 Nov 16.

    PubMed 29143919

  • Wysham C, Bonadonna RC, Aroda VR, Puig Domingo M, Kapitza C, Stager W, Yu C, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L trial investigators. Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial. Diabetes Obes Metab. 2017 Oct;19(10):1408-1415. doi: 10.1111/dom.12961. Epub 2017 Jun 8.

    PubMed 28386990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Metformin (Background Drug) in people with Type 2 Diabetes, run by Sanofi at 236 sites in 18 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 12 inclusion and 23 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 236 sites in United States, Russia, Canada, Czechia, Romania and 13 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 Glycated Hemoglobin (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 NCT02058160, which also lists 10 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.

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