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

NCT02058160 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC124052013-003132-79U1111-1148-4351
• Study Type: interventional
• Target: 736
• Locations: 17 countries
• Sites: 233

Brief 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. 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, Week 30

Secondary Outcomes (14)

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

  Week 30

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

  Baseline, Week 30

• Change in Body Weight From Baseline to Week 30

  Baseline, Week 30

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

  Baseline, Week 30

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

  Week 30

Study Arms (2)

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

EXPERIMENTAL

FRC once daily (QD) for 30 weeks. Dose individually adjusted.

Drug: Insulin glargine/lixisenatide (HOE901/AVE0010); Drug: Metformin (Background Drug)

Insulin glargine

ACTIVE COMPARATOR

Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.

Drug: Insulin glargine (HOE901); Drug: Metformin (Background Drug)

Interventions

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/Lixisenatide Fixed Ratio Combination (FRC)

Insulin glargine (HOE901) DRUG

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).

Also known as: Lantus

Insulin glargine

Metformin (Background Drug) DRUG

Pharmaceutical form: Tablet; Route of administration: Oral administration

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC); Insulin glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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.

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (236)

Investigational Site Number 840607

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 840570

Sun City, Arizona, 85351, United States

Location

Investigational Site Number 840562

Tempe, Arizona, United States

Location

Investigational Site Number 840577

Tucson, Arizona, 85723, United States

Location

Investigational Site Number 840517

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840537

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840568

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840550

Chino, California, 91710, United States

Location

Investigational Site Number 840529

Chula Vista, California, 91911, United States

Location

Investigational Site Number 840623

Corona, California, 92879, United States

Location

Investigational Site Number 840566

Fresno, California, 93720, United States

Location

Investigational Site Number 840552

Greenbrae, California, 94904, United States

Location

Investigational Site Number 840578

Lancaster, California, 93534, United States

Location

Investigational Site Number 840626

Los Angeles, California, 90017, United States

Location

Investigational Site Number 840581

Los Angeles, California, 90057, United States

Location

Investigational Site Number 840621

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 840511

Northridge, California, 91325, United States

Location

Investigational Site Number 840573

Palm Springs, California, 92262, United States

Location

Investigational Site Number 840559

Port Hueneme, California, 93041, United States

Location

Investigational Site Number 840536

San Ramon, California, 94583, United States

Location

Investigational Site Number 840567

Santa Ana, California, 92704, United States

Location

Investigational Site Number 840569

Tarzana, California, 91356, United States

Location

Investigational Site Number 840572

West Hills, California, 91345, United States

Location

Investigational Site Number 840582

Aurora, Colorado, 80045, United States

Location

Investigational Site Number 840509

Denver, Colorado, 80246, United States

Location

Investigational Site Number 840549

Wilmington, Delaware, 19713, United States

Location

Investigational Site Number 840510

Miami, Florida, 33156-7563, United States

Location

Investigational Site Number 840521

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840602

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840538

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840534

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840594

Atlanta, Georgia, 30322, United States

Location

Investigational Site Number 840614

Columbus, Georgia, 31904, United States

Location

Investigational Site Number 840501

Lawrenceville, Georgia, 30046, United States

Location

Investigational Site Number 840525

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840588

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 840580

Arlington Heights, Illinois, 60005, United States

Location

Investigational Site Number 840519

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 840612

Chicago, Illinois, 60616, United States

Location

Investigational Site Number 840556

Springfield, Illinois, 62704, United States

Location

Investigational Site Number 840543

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840565

Evansville, Indiana, 47713, United States

Location

Investigational Site Number 840585

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840615

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840563

Indianapolis, Indiana, 46202, United States

Location

Investigational Site Number 840507

Indianapolis, Indiana, 46260, United States

Location

Investigational Site Number 840516

Louisville, Kentucky, 40213, United States

Location

Investigational Site Number 840595

Lewiston, Maine, 04240, United States

Location

Investigational Site Number 840520

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 840560

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 840522

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 840505

Dearborn, Michigan, 48124, United States

Location

Investigational Site Number 840575

Flint, Michigan, 48504, United States

Location

Investigational Site Number 840564

Minneapolis, Minnesota, 55416, United States

Location

Investigational Site Number 840558

Butte, Montana, 59701, United States

Location

Investigational Site Number 840506

Omaha, Nebraska, 68131, United States

Location

Investigational Site Number 840600

Henderson, Nevada, 89074, United States

Location

Investigational Site Number 840532

Las Vegas, Nevada, 89119, United States

Location

Investigational Site Number 840599

Las Vegas, Nevada, 89148, United States

Location

Investigational Site Number 840539

Nashua, New Hampshire, 03063, United States

Location

Investigational Site Number 840576

Albuquerque, New Mexico, 87131, United States

Location

Investigational Site Number 840583

Jamaica, New York, 11432, United States

Location

Investigational Site Number 840531

New Hyde Park, New York, 11042, United States

Location

Investigational Site Number 840557

Syracuse, New York, 13214-2016, United States

Location

Investigational Site Number 840541

Durham, North Carolina, 27710, United States

Location

Investigational Site Number 840604

Greenville, North Carolina, 27858, United States

Location

Investigational Site Number 840540

Hickory, North Carolina, 28601, United States

Location

Investigational Site Number 840513

Morehead City, North Carolina, 28557, United States

Location

Investigational Site Number 840592

Salisbury, North Carolina, 28144, United States

Location

Investigational Site Number 840535

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840515

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 840579

Columbus, Ohio, 43213, United States

Location

Investigational Site Number 840524

Dayton, Ohio, 45439, United States

Location

Investigational Site Number 840503

Maumee, Ohio, 43537, United States

Location

Investigational Site Number 840618

Eugene, Oregon, 97404, United States

Location

Investigational Site Number 840610

Philadelphia, Pennsylvania, 19107, United States

Location

Investigational Site Number 840551

Smithfield, Pennsylvania, 15478, United States

Location

Investigational Site Number 840584

Tipton, Pennsylvania, 16684, United States

Location

Investigational Site Number 840622

Charleston, South Carolina, 29407, United States

Location

Investigational Site Number 840611

Rapid City, South Dakota, 57701, United States

Location

Investigational Site Number 840605

Amarillo, Texas, 79106, United States

Location

Investigational Site Number 840553

Austin, Texas, 78731, United States

Location

Investigational Site Number 840598

Austin, Texas, 78731, United States

Location

Investigational Site Number 840502

Corpus Christi, Texas, 78404, United States

Location

Investigational Site Number 840601

Dallas, Texas, 75208, United States

Location

Investigational Site Number 840586

Dallas, Texas, 75216, United States

Location

Investigational Site Number 840547

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840530

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840545

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840554

Edinburg, Texas, 78539, United States

Location

Investigational Site Number 840544

Houston, Texas, 77030, United States

Location

Investigational Site Number 840514

Hurst, Texas, 76054, United States

Location

Investigational Site Number 840617

N Richland Hill, Texas, 76180, United States

Location

Investigational Site Number 840512

Draper, Utah, 84020, United States

Location

Investigational Site Number 840591

Murray, Utah, 84123, United States

Location

Investigational Site Number 840526

Ogden, Utah, 84405, United States

Location

Investigational Site Number 840597

Orem, Utah, 84058, United States

Location

Investigational Site Number 840590

Salt Lake City, Utah, 84102, United States

Location

Investigational Site Number 840613

Burlington, Vermont, 05401, United States

Location

Investigational Site Number 840504

Chesapeake, Virginia, 23321, United States

Location

Investigational Site Number 840561

Norfolk, Virginia, 23510, United States

Location

Investigational Site Number 840625

Norfolk, Virginia, 23510, United States

Location

Investigational Site Number 840606

Richmond, Virginia, 23227, United States

Location

Investigational Site Number 840608

Salem, Virginia, 24153, United States

Location

Investigational Site Number 840571

Federal Way, Washington, 98003, United States

Location

Investigational Site Number 840593

Spokane, Washington, 99220, United States

Location

Investigational Site Number 840609

Tacoma, Washington, 98415-0299, United States

Location

Investigational Site Number 840546

Milwaukee, Wisconsin, 53209-0996, United States

Location

Investigational Site Number 036505

Box Hill, 3128, Australia

Location

Investigational Site Number 036501

Heidelberg, 3081, Australia

Location

Investigational Site Number 036504

Parkville, 3050, Australia

Location

Investigational Site Number 124504

Beamsville, L0R 1B0, Canada

Location

Investigational Site Number 124512

Brampton, L6R 3J5, Canada

Location

Investigational Site Number 124502

Guelph, N1H 1B1, Canada

Location

Investigational Site Number 124507

Kelowna, V1Y 1Z9, Canada

Location

Investigational Site Number 124505

Montreal, H1W 2R7, Canada

Location

Investigational Site Number 124511

Oakville, L6H 3P1, Canada

Location

Investigational Site Number 124509

Saint Romuald, G6W 5M6, Canada

Location

Investigational Site Number 124503

Toronto, M9V 4B4, Canada

Location

Investigational Site Number 124510

Toronto, M9W 4L9, Canada

Location

Investigational Site Number 124501

Vancouver, V5Y 3W2, Canada

Location

Investigational Site Number 124508

Victoria, V8V 4A1, Canada

Location

Investigational Site Number 152511

Puerto Varas, 5480000, Chile

Location

Investigational Site Number 152502

Santiago, 7500347, Chile

Location

Investigational Site Number 152501

Santiago, 7500710, Chile

Location

Investigational Site Number 152514

Santiago, 7500739, Chile

Location

Investigational Site Number 152503

Santiago, 8053095, Chile

Location

Investigational Site Number 152507

Santiago, Chile

Location

Investigational Site Number 152509

Talagante, Chile

Location

Investigational Site Number 152513

Temuco, 4780000, Chile

Location

Investigational Site Number 152504

Viña del Mar, Chile

Location

Investigational Site Number 203502

Cheb, 35002, Czechia

Location

Investigational Site Number 203504

Hranice, 75301, Czechia

Location

Investigational Site Number 203507

Krnov, 79401, Czechia

Location

Investigational Site Number 203506

Liberec, 460 01, Czechia

Location

Investigational Site Number 203503

Olomouc, 77900, Czechia

Location

Investigational Site Number 203514

Pilsen, 301 66, Czechia

Location

Investigational Site Number 203515

Pilsen, 301 66, Czechia

Location

Investigational Site Number 203511

Prague, 14900, Czechia

Location

Investigational Site Number 203508

Prague, 15030, Czechia

Location

Investigational Site Number 203509

Prague, 18100, Czechia

Location

Investigational Site Number 203505

Prostějov, 79601, Czechia

Location

Investigational Site Number 208503

Aarhus C, 8000, Denmark

Location

Investigational Site Number 208509

Horsens, 8700, Denmark

Location

Investigational Site Number 208502

Kolding, 6000, Denmark

Location

Investigational Site Number 208501

København NV, 2400, Denmark

Location

Investigational Site Number 208505

København S, 2300, Denmark

Location

Investigational Site Number 208504

Viborg, 8800, Denmark

Location

Investigational Site Number 233502

Pärnu, 80018, Estonia

Location

Investigational Site Number 233503

Tallinn, 10138, Estonia

Location

Investigational Site Number 233501

Tartu, 50406, Estonia

Location

Investigational Site Number 348503

Budapest, 1134, Hungary

Location

Investigational Site Number 348501

Budapest, 1138, Hungary

Location

Investigational Site Number 348505

Budapest, 1212, Hungary

Location

Investigational Site Number 348502

Debrecen, 4031, Hungary

Location

Investigational Site Number 348506

Kaposvár, 7400, Hungary

Location

Investigational Site Number 348504

Pápa, 8500, Hungary

Location

Investigational Site Number 440501

Kaunas, 48259, Lithuania

Location

Investigational Site Number 440503

Kaunas, 49449, Lithuania

Location

Investigational Site Number 440505

Kėdainiai, LT-57164, Lithuania

Location

Investigational Site Number 440504

Klaipėda, LT-92253, Lithuania

Location

Investigational Site Number 440502

Vilnius, LT-10323, Lithuania

Location

Investigational Site Number 484508

Celaya, 38000, Mexico

Location

Investigational Site Number 484501

Cuernavaca, 62250, Mexico

Location

Investigational Site Number 484503

Guadalajara, 44130, Mexico

Location

Investigational Site Number 484504

Guadalajara, 44210, Mexico

Location

Investigational Site Number 484506

Guadalajara, 44600, Mexico

Location

Investigational Site Number 484509

México, 06700, Mexico

Location

Investigational Site Number 484507

Pachuca, 42084, Mexico

Location

Investigational Site Number 484505

Puebla City, 72190, Mexico

Location

Investigational Site Number 528505

Almere Stad, 1311 RL, Netherlands

Location

Investigational Site Number 616502

Bialystok, 15-435, Poland

Location

Investigational Site Number 616505

Krakow, 31-261, Poland

Location

Investigational Site Number 616506

Krakow, 31-548, Poland

Location

Investigational Site Number 616507

Płock, 09-400, Poland

Location

Investigational Site Number 616504

Szczecin, 70-506, Poland

Location

Investigational Site Number 616503

Warsaw, 01-518, Poland

Location

Investigational Site Number 616501

Warsaw, 02-507, Poland

Location

Investigational Site Number 642507

Brasov, 500365, Romania

Location

Investigational Site Number 642510

Bucharest, 010825, Romania

Location

Investigational Site Number 642508

Bucharest, 020042, Romania

Location

Investigational Site Number 642509

Bucharest, 020475, Romania

Location

Investigational Site Number 642506

Hunedoara, 331057, Romania

Location

Investigational Site Number 642505

Iași, 700547, Romania

Location

Investigational Site Number 642502

Oradea, 410169, Romania

Location

Investigational Site Number 642511

Sibiu, 550371, Romania

Location

Investigational Site Number 642501

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642504

Timișoara, 300125, Romania

Location

Investigational Site Number 642503

Timișoara, 300456, Romania

Location

Investigational Site Number 643511

Arkhangelsk, 163045, Russia

Location

Investigational Site Number 643512

Moscow, 119435, Russia

Location

Investigational Site Number 643508

Penza, 440026, Russia

Location

Investigational Site Number 643501

Saint Petersburg, 190013, Russia

Location

Investigational Site Number 643506

Saint Petersburg, 194291, Russia

Location

Investigational Site Number 643503

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643504

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643505

Saint Petersburg, 194358, Russia

Location

Investigational Site Number 643502

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643513

Samara, 443041, Russia

Location

Investigational Site Number 643507

Saratov, 410030, Russia

Location

Investigational Site Number 643514

Saratov, 410053, Russia

Location

Investigational Site Number 643509

Voronezh, 394018, Russia

Location

Investigational Site Number 703505

Bratislava, 85101, Slovakia

Location

Investigational Site Number 703507

Bytča, 01401, Slovakia

Location

Investigational Site Number 703502

Košice, 04001, Slovakia

Location

Investigational Site Number 703512

Košice, 04001, Slovakia

Location

Investigational Site Number 703510

Košice, 04013, Slovakia

Location

Investigational Site Number 703511

Ľubochňa, 3491, Slovakia

Location

Investigational Site Number 703508

Moldava nad Bodvou, 04525, Slovakia

Location

Investigational Site Number 703504

Nové Mesto nad Váhom, 91501, Slovakia

Location

Investigational Site Number 703509

Nové Zámky, 94001, Slovakia

Location

Investigational Site Number 703513

Trnava, 91701, Slovakia

Location

Investigational Site Number 703501

Žilina, 01001, Slovakia

Location

Investigational Site Number 724508

A Coruña, 15006, Spain

Location

Investigational Site Number 724509

Alicante, 03010, Spain

Location

Investigational Site Number 724506

Alzira, 46600, Spain

Location

Investigational Site Number 724504

Barcelona, 08035, Spain

Location

Investigational Site Number 724510

Barcelona, 08036, Spain

Location

Investigational Site Number 724505

Cáceres, 10003, Spain

Location

Investigational Site Number 724503

Ferrol, 15405, Spain

Location

Investigational Site Number 724501

Sabadell, 08208, Spain

Location

Investigational Site Number 724507

Segovia, 40002, Spain

Location

Investigational Site Number 724502

Valencia, 46014, Spain

Location

Investigational Site Number 752501

Ljungby, 341 82, Sweden

Location

Investigational Site Number 752503

Malmo, 211 52, Sweden

Location

Investigational Site Number 752504

Rättvik, 79530, Sweden

Location

Investigational Site Number 752506

Stenungssund, 44431, Sweden

Location

Investigational Site Number 752505

Stockholm, 11526, Sweden

Location

Investigational Site Number 752502

Vällingby, 16268, Sweden

Location

Investigational Site Number 804501

Chernivtsi, 58022, Ukraine

Location

Investigational Site Number 804510

Kyiv, 03049, Ukraine

Location

Investigational Site Number 804507

Kyiv, 04050, Ukraine

Location

Investigational Site Number 804511

Kyiv, Ukraine

Location

Investigational Site Number 804513

Lviv, 79010, Ukraine

Location

Investigational Site Number 804502

Vinnytsia, 21001, Ukraine

Location

Investigational Site Number 804508

Vinnytsia, 21010, Ukraine

Location

Related Publications (10)

• 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.

  PMID: 27650977 RESULT

• 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.

  PMID: 31848983 DERIVED

• 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.

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• 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.

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• 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.

  PMID: 30550345 DERIVED

• 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.

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• 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.

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• 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.

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• 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.

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  PMID: 28386990 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 9, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-03

Locations

ES (10); ME (8); NL (1); US (108); SL (11); PL (7); RU (13); AU (3); HU (6); DK (6); CA (11); CL (9); UA (7); SE (6); CZ (11); LI (5); RO (11)