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

NCT02058147 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC124042013-003131-30U1111-1148-4334
• Study Type: interventional
• Target: 1,170
• Locations: 22 countries
• Sites: 269

Brief 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. 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 30

Secondary Outcomes (14)

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

  Week 30

• Change in Plasma Glucose Excursion From Baseline to Week 30

  Baseline, Week 30

• Change in Body Weight From Baseline to Week 30

  Baseline, Week 30

• Change in Fasting Plasma Glucose (FPG) 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

Study Arms (3)

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

EXPERIMENTAL

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

Drug: Insulin glargine/lixisenatide Fixed Ratio Combination; Drug: Metformin

Insulin Glargine

ACTIVE COMPARATOR

Insulin glargine QD for 30 weeks. Dose individually adjusted.

Drug: Insulin glargine (HOE901); Drug: Metformin

Lixisenatide

ACTIVE COMPARATOR

Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).

Drug: Lixisenatide (AVE0010); Drug: Metformin

Interventions

Insulin glargine/lixisenatide Fixed Ratio Combination DRUG

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.

Also known as: (HOE901/AVE0010)

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

Insulin glargine (HOE901) DRUG

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.

Also known as: Lantus

Insulin Glargine

Lixisenatide (AVE0010) DRUG

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.

Also known as: Lyxumia

Lixisenatide

Metformin DRUG

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (273)

Investigational Site Number 840027

Phoenix, Arizona, 85028, United States

Location

Investigational Site Number 840122

Phoenix, Arizona, 85032, United States

Location

Investigational Site Number 840062

Tempe, Arizona, 85282, United States

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Investigational Site Number 840023

Tempe, Arizona, United States

Location

Investigational Site Number 840084

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840100

Anaheim, California, 92801, United States

Location

Investigational Site Number 840065

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840090

Chino, California, 91710, United States

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Investigational Site Number 840002

Chula Vista, California, 91911, United States

Location

Investigational Site Number 840013

Concord, California, 94520, United States

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Investigational Site Number 840053

Fresno, California, 93720, United States

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Investigational Site Number 840017

La Jolla, California, 92037, United States

Location

Investigational Site Number 840070

Lancaster, California, 93534, United States

Location

Investigational Site Number 840121

Long Beach, California, 90806, United States

Location

Investigational Site Number 840126

Los Angeles, California, 90017, United States

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Investigational Site Number 840044

Los Angeles, California, 90057, United States

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Investigational Site Number 840101

Mission Hills, California, 91345, United States

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Investigational Site Number 840086

Mission Viejo, California, 92691, United States

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Investigational Site Number 840120

Mission Viejo, California, 92691, United States

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Investigational Site Number 840005

Northridge, California, 91325, United States

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Investigational Site Number 840034

Palm Springs, California, 92262, United States

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Investigational Site Number 840074

Port Hueneme, California, 93041, United States

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Investigational Site Number 840068

San Ramon, California, 94583, United States

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Investigational Site Number 840067

Santa Ana, California, 92704, United States

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Investigational Site Number 840029

Tarzana, California, 91356, United States

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Investigational Site Number 840006

Temecula, California, 92591, United States

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Investigational Site Number 840078

West Hills, California, 91345, United States

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Investigational Site Number 840059

Aurora, Colorado, 80045, United States

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Investigational Site Number 840038

Denver, Colorado, 80246, United States

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Investigational Site Number 840104

Bradenton, Florida, 34208, United States

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Investigational Site Number 840098

Miami, Florida, 33156-7563, United States

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Investigational Site Number 840014

New Port Richey, Florida, 34652, United States

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Investigational Site Number 840047

Ocoee, Florida, 34761, United States

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Investigational Site Number 840056

Palm Harbor, Florida, 34684, United States

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Investigational Site Number 840089

Atlanta, Georgia, 30322, United States

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Investigational Site Number 840054

Lawrenceville, Georgia, 30046, United States

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Investigational Site Number 840119

Woodstock, Georgia, 30189, United States

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Investigational Site Number 840108

Idaho Falls, Idaho, 83404, United States

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Investigational Site Number 840075

Arlington Heights, Illinois, 60005, United States

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Investigational Site Number 840080

Chicago, Illinois, 60607, United States

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Investigational Site Number 840026

Chicago, Illinois, 60612, United States

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Investigational Site Number 840116

Chicago, Illinois, 60616, United States

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Investigational Site Number 840050

Springfield, Illinois, 62704, United States

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Investigational Site Number 840008

Avon, Indiana, 46123, United States

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Investigational Site Number 840015

Avon, Indiana, 46123, United States

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Investigational Site Number 840076

Avon, Indiana, 46123, United States

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Investigational Site Number 840082

Evansville, Indiana, 47713, United States

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Investigational Site Number 840031

Evansville, Indiana, 47714, United States

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Investigational Site Number 840060

Evansville, Indiana, 47714, United States

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Investigational Site Number 840048

Indianapolis, Indiana, 46202, United States

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Investigational Site Number 840085

Indianapolis, Indiana, 46260, United States

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Investigational Site Number 840012

Valparaiso, Indiana, United States

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Investigational Site Number 840025

Waterloo, Iowa, 50702, United States

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Investigational Site Number 840022

Lexington, Kentucky, 40504, United States

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Investigational Site Number 840007

Louisville, Kentucky, 40213, United States

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Investigational Site Number 840081

New Orleans, Louisiana, 70112, United States

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Investigational Site Number 840097

Auburn, Maine, 04210, United States

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Investigational Site Number 840063

Rockville, Maryland, 20852, United States

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Investigational Site Number 840028

Bloomfield Hills, Michigan, United States

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Investigational Site Number 840071

Chesterfield, Michigan, 48047, United States

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Investigational Site Number 840001

Dearborn, Michigan, 48124, United States

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Investigational Site Number 840091

Kalamazoo, Michigan, 49048, United States

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Investigational Site Number 840009

Minneapolis, Minnesota, 55416, United States

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Investigational Site Number 840024

Chesterfield, Missouri, 63017, United States

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Investigational Site Number 840057

Butte, Montana, 59701, United States

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Investigational Site Number 840042

Omaha, Nebraska, 68131, United States

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Investigational Site Number 840109

Henderson, Nevada, 89052, United States

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Investigational Site Number 840052

Las Vegas, Nevada, 89148, United States

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Investigational Site Number 840069

Nashua, New Hampshire, 03063, United States

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Investigational Site Number 840123

Morganville, New Jersey, 07751, United States

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Investigational Site Number 840011

Albuquerque, New Mexico, 87131, United States

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Investigational Site Number 840030

New Hyde Park, New York, 11042, United States

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Investigational Site Number 840096

Syracuse, New York, 13214-2016, United States

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Investigational Site Number 840039

Asheville, North Carolina, 28803, United States

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Investigational Site Number 840021

Hickory, North Carolina, 28601, United States

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Investigational Site Number 840046

Morehead City, North Carolina, 28557, United States

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Investigational Site Number 840072

Morganton, North Carolina, 28655, United States

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Investigational Site Number 840110

Salisbury, North Carolina, 28144, United States

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Investigational Site Number 840095

Wilmington, North Carolina, 28401, United States

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Investigational Site Number 840099

Winston-Salem, North Carolina, 27103, United States

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Investigational Site Number 840004

Columbus, Ohio, 43213, United States

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Investigational Site Number 840016

Maumee, Ohio, 43537, United States

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Investigational Site Number 840103

Eugene, Oregon, 97404, United States

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Investigational Site Number 840113

Portland, Oregon, 97201-3098, United States

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Investigational Site Number 840036

Pittsburgh, Pennsylvania, 15473, United States

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Investigational Site Number 840043

Tipton, Pennsylvania, 16684, United States

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Investigational Site Number 840058

Anderson, South Carolina, 29621, United States

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Investigational Site Number 840127

Charleston, South Carolina, 29407, United States

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Investigational Site Number 840049

Greer, South Carolina, 29651, United States

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Investigational Site Number 840114

Rapid City, South Dakota, 57701, United States

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Investigational Site Number 840112

Bristol, Tennessee, 37620, United States

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Investigational Site Number 840094

Knoxville, Tennessee, 37912, United States

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Investigational Site Number 840051

Austin, Texas, 78758, United States

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Investigational Site Number 840066

Corpus Christi, Texas, 78404, United States

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Investigational Site Number 840111

Dallas, Texas, 75208, United States

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Investigational Site Number 840020

Dallas, Texas, 75216, United States

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Investigational Site Number 840064

Dallas, Texas, 75230, United States

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Investigational Site Number 840003

Dallas, Texas, 75231, United States

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Investigational Site Number 840088

Edinburg, Texas, 78539, United States

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Investigational Site Number 840118

Fort Worth, Texas, 76132, United States

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Investigational Site Number 840055

Houston, Texas, 77004, United States

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Investigational Site Number 840087

Houston, Texas, 77030, United States

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Investigational Site Number 840079

Hurst, Texas, 76054, United States

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Investigational Site Number 840073

N Richland Hill, Texas, 76180, United States

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Investigational Site Number 840019

San Antonio, Texas, 78229, United States

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Investigational Site Number 840037

Draper, Utah, 84020, United States

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Investigational Site Number 840093

Ogden, Utah, 84405, United States

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Investigational Site Number 840061

Salt Lake City, Utah, 84102, United States

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Investigational Site Number 840041

Salt Lake City, Utah, 84107, United States

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Investigational Site Number 840040

Chesapeake, Virginia, 23321, United States

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Investigational Site Number 840045

Norfolk, Virginia, 23510, United States

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Investigational Site Number 840092

Norfolk, Virginia, 23510, United States

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Investigational Site Number 840125

Richmond, Virginia, 23219, United States

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Investigational Site Number 840115

Salem, Virginia, 24153, United States

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Investigational Site Number 840010

Weber City, Virginia, 24290, United States

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Investigational Site Number 840077

Federal Way, Washington, 98003, United States

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Investigational Site Number 840102

Renton, Washington, 98055, United States

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Investigational Site Number 840033

Milwaukee, Wisconsin, 53209-0996, United States

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Investigational Site Number 036005

Box Hill, 3128, Australia

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Investigational Site Number 036001

Camperdown, 2050, Australia

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Investigational Site Number 036006

Kippa-Ring, 4021, Australia

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Investigational Site Number 036007

Logan Central, 4114, Australia

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Investigational Site Number 056005

Brussels, 1070, Belgium

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Investigational Site Number 056006

Brussels, 1090, Belgium

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Investigational Site Number 056001

Leuven, 3000, Belgium

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Investigational Site Number 124004

Kelowna, V1Y 1Z9, Canada

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Investigational Site Number 124001

Toronto, M4G 3E8, Canada

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Investigational Site Number 124002

Vancouver, V5Z 1M9, Canada

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Investigational Site Number 152008

Osorno, 5311092, Chile

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Investigational Site Number 152015

Puerto Varas, Chile

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Investigational Site Number 152004

Santiago, 7500010, Chile

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Investigational Site Number 152006

Santiago, 7500010, Chile

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Investigational Site Number 152001

Santiago, 7591047, Chile

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Investigational Site Number 152002

Santiago, 7980378, Chile

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Investigational Site Number 152012

Santiago, 8053095, Chile

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Investigational Site Number 152009

Santiago, 8330008, Chile

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Investigational Site Number 152011

Talagante, Chile

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Investigational Site Number 152014

Temuco, 4781156, Chile

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Investigational Site Number 152003

Temuco, 4813299, Chile

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Investigational Site Number 203004

Beroun, 26601, Czechia

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Investigational Site Number 203008

České Budějovice, 370 01, Czechia

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Investigational Site Number 203014

Hořovice, 26801, Czechia

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Investigational Site Number 203012

Kopřivnice, 742 21, Czechia

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Investigational Site Number 203001

Pardubice, 53002, Czechia

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Investigational Site Number 203005

Pilsen, 32600, Czechia

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Investigational Site Number 203003

Prague, 100 00, Czechia

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Investigational Site Number 203009

Prague, 12808, Czechia

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Investigational Site Number 203007

Prague, 15000, Czechia

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Investigational Site Number 203013

Praha 9 - Klanovice, 19014, Czechia

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Investigational Site Number 203006

Trutnov, 54101, Czechia

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Investigational Site Number 203016

Újezd u Brna, Czechia

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Investigational Site Number 203015

Vsetín, 75501, Czechia

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Investigational Site Number 208003

Aarhus C, 8000, Denmark

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Investigational Site Number 208009

Horsens, 8700, Denmark

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Investigational Site Number 208002

Kolding, 6000, Denmark

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Investigational Site Number 208001

København NV, 2400, Denmark

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Investigational Site Number 208005

København S, 2300, Denmark

Location

Investigational Site Number 208004

Viborg, 8800, Denmark

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Investigational Site Number 233004

Paide, 72713, Estonia

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Investigational Site Number 233002

Pärnu, 80018, Estonia

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Investigational Site Number 233003

Tallinn, 13415, Estonia

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Investigational Site Number 233001

Viljandimaa, 71024, Estonia

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Investigational Site Number 250006

Corbeil-Essonnes, 91109, France

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Investigational Site Number 250002

La Rochelle, 17019, France

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Investigational Site Number 250003

Pierre-Bénite, 69310, France

Location

Investigational Site Number 250001

Vénissieux, 69200, France

Location

Investigational Site Number 276005

Berlin, 10115, Germany

Location

Investigational Site Number 276003

Berlin, 13125, Germany

Location

Investigational Site Number 276004

Dortmund, 44137, Germany

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Investigational Site Number 276007

Dresden, 01069, Germany

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Investigational Site Number 276001

Dresden, 01307, Germany

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Investigational Site Number 276006

Hamburg, 20253, Germany

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Investigational Site Number 276002

Neumünster, 24534, Germany

Location

Investigational Site Number 348003

Balatonfüred, 8230, Hungary

Location

Investigational Site Number 348007

Budapest, 1036, Hungary

Location

Investigational Site Number 348006

Budapest, 1096, Hungary

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Investigational Site Number 348002

Budapest, 1138, Hungary

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Investigational Site Number 348011

Komárom, 2900, Hungary

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Investigational Site Number 348008

Nagykanizsa, 8800, Hungary

Location

Investigational Site Number 348012

Sátoraljaújhely, 3980, Hungary

Location

Investigational Site Number 348004

Szeged, 6720, Hungary

Location

Investigational Site Number 348010

Székesfehérvár, 8000, Hungary

Location

Investigational Site Number 348001

Zalaegerszeg, 8900, Hungary

Location

Investigational Site Number 380002

Bologna, 40138, Italy

Location

Investigational Site Number 380006

Catanzaro, 88100, Italy

Location

Investigational Site Number 380001

Milan, 20132, Italy

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Investigational Site Number 380003

Napoli, 80131, Italy

Location

Investigational Site Number 380005

Roma, 00133, Italy

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Investigational Site Number 428002

Riga, LV-1011, Latvia

Location

Investigational Site Number 428003

Riga, LV-1011, Latvia

Location

Investigational Site Number 428004

Riga, LV-1050, Latvia

Location

Investigational Site Number 428001

Sigulda, LV-2150, Latvia

Location

Investigational Site Number 440003

Jonava, LT-55201, Lithuania

Location

Investigational Site Number 440002

Kaunas, LT-49456, Lithuania

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Investigational Site Number 440007

Kaunas, LT-50009, Lithuania

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Investigational Site Number 440004

Kėdainiai, LT-57164, Lithuania

Location

Investigational Site Number 440006

Panevezys, LT-37355, Lithuania

Location

Investigational Site Number 440005

Utena, LT-28151, Lithuania

Location

Investigational Site Number 440001

Vilnius, LT-10323, Lithuania

Location

Investigational Site Number 484005

Aguascalientes, 20230, Mexico

Location

Investigational Site Number 484001

Cuernavaca, 62250, Mexico

Location

Investigational Site Number 484002

Guadalajara, 44130, Mexico

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Investigational Site Number 484004

Guadalajara, 44210, Mexico

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Investigational Site Number 484009

Guadalajara, 44670, Mexico

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Investigational Site Number 484007

Monterrey, 64020, Mexico

Location

Investigational Site Number 484006

Monterrey, 64460, Mexico

Location

Investigational Site Number 484010

Zapopan, 45116, Mexico

Location

Investigational Site Number 616002

Bialystok, 15-435, Poland

Location

Investigational Site Number 616005

Krakow, 31-261, Poland

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Investigational Site Number 616006

Krakow, 31-548, Poland

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Investigational Site Number 616007

Lodz, 94-074, Poland

Location

Investigational Site Number 616004

Szczecin, 70-506, Poland

Location

Investigational Site Number 616003

Warsaw, 01-518, Poland

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Investigational Site Number 616001

Warsaw, 02-507, Poland

Location

Investigational Site Number 616008

Żory, 44-240, Poland

Location

Investigational Site Number 642008

Bucharest, 010825, Romania

Location

Investigational Site Number 642007

Bucharest, 020475, Romania

Location

Investigational Site Number 642009

Cluj-Napoca, 400006, Romania

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Investigational Site Number 642006

Hunedoara, 331057, Romania

Location

Investigational Site Number 642005

Iași, 700547, Romania

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Investigational Site Number 642002

Oradea, 410169, Romania

Location

Investigational Site Number 642001

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642004

Timișoara, 300133, Romania

Location

Investigational Site Number 642003

Timișoara, 300456, Romania

Location

Investigational Site Number 643006

Moscow, 119991, Russia

Location

Investigational Site Number 643008

Penza, 440026, Russia

Location

Investigational Site Number 643012

Petrozavodsk, 185019, Russia

Location

Investigational Site Number 643001

Saint Petersburg, 190013, Russia

Location

Investigational Site Number 643005

Saint Petersburg, 190068, Russia

Location

Investigational Site Number 643007

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643003

Saint Petersburg, 194358, Russia

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Investigational Site Number 643002

Saint Petersburg, 195257, Russia

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Investigational Site Number 643014

Samara, 443067, Russia

Location

Investigational Site Number 643009

Saratov, 410026, Russia

Location

Investigational Site Number 643011

Saratov, 410053, Russia

Location

Investigational Site Number 643016

Tomsk, 634050, Russia

Location

Investigational Site Number 643004

Voronezh, 394018, Russia

Location

Investigational Site Number 710002

Cap Town, 7530, South Africa

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Investigational Site Number 710003

Cape Town, 7500, South Africa

Location

Investigational Site Number 710005

Meyerspark, 0184, South Africa

Location

Investigational Site Number 710007

Port Elizabeth, South Africa

Location

Investigational Site Number 710004

Pretoria, 0122, South Africa

Location

Investigational Site Number 710001

Somerset West, 7130, South Africa

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Investigational Site Number 710006

Soweto, 4309, South Africa

Location

Investigational Site Number 724011

A Coruña, 15006, Spain

Location

Investigational Site Number 724012

Barcelona, 08003, Spain

Location

Investigational Site Number 724009

Granada, 18012, Spain

Location

Investigational Site Number 724004

Hostalets de Balenyà, 08550, Spain

Location

Investigational Site Number 724007

Lugo, 27004, Spain

Location

Investigational Site Number 724008

Madrid, 28034, Spain

Location

Investigational Site Number 724005

Madrid, 28046, Spain

Location

Investigational Site Number 724013

Palma de Mallorca, 07010, Spain

Location

Investigational Site Number 724001

Quart de Poblet, 46930, Spain

Location

Investigational Site Number 724006

Sant Joan Despí, 08970, Spain

Location

Investigational Site Number 724003

Seville, 41010, Spain

Location

Investigational Site Number 752001

Ljungby, 341 82, Sweden

Location

Investigational Site Number 752003

Malmo, 211 52, Sweden

Location

Investigational Site Number 752004

Rättvik, 79530, Sweden

Location

Investigational Site Number 752005

Stockholm, 11526, Sweden

Location

Investigational Site Number 752002

Vällingby, 16268, Sweden

Location

Investigational Site Number 804002

Chernivtsi, 58022, Ukraine

Location

Investigational Site Number 804009

Ivano-Frankivsk, 76008, Ukraine

Location

Investigational Site Number 804010

Kyiv, 03049, Ukraine

Location

Investigational Site Number 804007

Kyiv, 04050, Ukraine

Location

Investigational Site Number 804006

Kyiv, Ukraine

Location

Investigational Site Number 804012

Lviv, 79010, Ukraine

Location

Investigational Site Number 804011

Vinnytsia, 21001, Ukraine

Location

Investigational Site Number 804008

Vinnytsia, 21010, Ukraine

Location

Investigational Site Number 826001

Coventry, CV2 2DX, United Kingdom

Location

Investigational Site Number 826002

Dundee, DD1 9SI, United Kingdom

Location

Investigational Site Number 826006

Guildford, GU2 7XX, United Kingdom

Location

Investigational Site Number 826007

Leicester, LE5 4PW, United Kingdom

Location

Investigational Site Number 826003

Norwich, NR1 3SR, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 27527848 RESULT

• 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.

  PMID: 35101326 DERIVED

• 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.

  PMID: 31124299 DERIVED

• 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.

  PMID: 31114694 DERIVED

• 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

• 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.

  PMID: 29974618 DERIVED

• 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.

  PMID: 29923298 DERIVED

• 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.

  PMID: 28432746 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: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 9, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-03

Locations

US (118); SE (5); RO (9); CZ (13); ES (11); HU (10); IT (5); FR (4); UA (8); LA (4); BE (3); AU (4); LI (7); CL (11); RU (13); ZA (7); GB (5); ME (8); PL (8); DK (6); DE (7); CA (3)