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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 (LixiLan-O)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin glargine/lixisenatide Fixed Ratio Combination

Insulin glargine (HOE901)

Lixisenatide (AVE0010)

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

HbA1c at screening visit:
- less than 7.5% or more than 10% for participants previously treated with metformin alone,
- less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
Any contraindication to metformin use, according to local labeling.
Use of weight loss drugs within 3 months prior to screening visit.
Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.
At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period:

HbA1c less than 7% or above 10%;
Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
Metformin maximal tolerated dose less than 1500 mg/day;
Amylase and/or lipase more than 3 ULN.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

Insulin Glargine

Lixisenatide

Arm Description

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

Insulin glargine QD for 30 weeks. Dose individually adjusted.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Change in Plasma Glucose Excursion From Baseline to Week 30

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

Change in Body Weight From Baseline to Week 30

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

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

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

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.

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

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).

Average Daily Insulin Glargine Dose at Week 30

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

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

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

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

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

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

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

Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

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

Percentage of Participants With Documented Symptomatic Hypoglycemia

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

Percentage of Participants With Severe Symptomatic Hypoglycemia

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

Full Information

NCT ID

NCT02058147

First Posted

February 6, 2014

Last Updated

March 31, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02058147

Brief Title

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

Acronym

LixiLan-O

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

Arm Type

Experimental

Arm Description

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

Arm Title

Insulin Glargine

Arm Type

Active Comparator

Arm Description

Insulin glargine QD for 30 weeks. Dose individually adjusted.

Arm Title

Lixisenatide

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin glargine/lixisenatide Fixed Ratio Combination

Other Intervention Name(s)

(HOE901/AVE0010)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (HOE901)

Other Intervention Name(s)

Lantus

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lixisenatide (AVE0010)

Other Intervention Name(s)

Lyxumia

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in HbA1c From Baseline to Week 30

Description

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.

Time Frame

Baseline, Week 30

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 30

Title

Change in Plasma Glucose Excursion From Baseline to Week 30

Description

Time Frame

Baseline, Week 30

Title

Change in Body Weight From Baseline to Week 30

Description

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

Time Frame

Baseline, Week 30

Title

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

Description

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

Time Frame

Baseline, Week 30

Title

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

Description

Time Frame

Baseline, Week 30

Title

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

Time Frame

Week 30

Title

Description

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).

Time Frame

Baseline up to Week 30

Title

Average Daily Insulin Glargine Dose at Week 30

Description

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

Time Frame

Week 30

Title

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

Description

Time Frame

Baseline, Week 30

Title

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

Description

Time Frame

Baseline up to Week 30

Title

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

Description

Time Frame

Baseline up to Week 30

Title

Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

Description

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

Time Frame

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

Title

Percentage of Participants With Documented Symptomatic Hypoglycemia

Description

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

Time Frame

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

Title

Percentage of Participants With Severe Symptomatic Hypoglycemia

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840027

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85028

Country

United States

Facility Name

Investigational Site Number 840122

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Investigational Site Number 840062

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840023

City

Tempe

State/Province

Arizona

Country

United States

Facility Name

Investigational Site Number 840084

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 840100

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Investigational Site Number 840065

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

Investigational Site Number 840090

City

Chino

State/Province

California

ZIP/Postal Code

91710

Country

United States

Facility Name

Investigational Site Number 840002

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Investigational Site Number 840013

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Investigational Site Number 840053

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840017

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Investigational Site Number 840070

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Investigational Site Number 840121

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Investigational Site Number 840126

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Investigational Site Number 840044

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 840101

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Investigational Site Number 840086

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840120

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840005

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Investigational Site Number 840034

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Investigational Site Number 840074

City

Port Hueneme

State/Province

California

ZIP/Postal Code

93041

Country

United States

Facility Name

Investigational Site Number 840068

City

San Ramon

State/Province

California

ZIP/Postal Code

94583

Country

United States

Facility Name

Investigational Site Number 840067

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Investigational Site Number 840029

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Investigational Site Number 840006

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Investigational Site Number 840078

City

West Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Investigational Site Number 840059

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Investigational Site Number 840038

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Investigational Site Number 840104

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Investigational Site Number 840098

City

Miami

State/Province

Florida

ZIP/Postal Code

33156-7563

Country

United States

Facility Name

Investigational Site Number 840014

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 840047

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 840056

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840089

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Investigational Site Number 840054

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Investigational Site Number 840119

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

Investigational Site Number 840108

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Investigational Site Number 840075

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Investigational Site Number 840080

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 840026

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Investigational Site Number 840116

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Investigational Site Number 840050

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Investigational Site Number 840008

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840015

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840076

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840082

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Investigational Site Number 840031

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840060

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840048

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Investigational Site Number 840085

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Investigational Site Number 840012

City

Valparaiso

State/Province

Indiana

Country

United States

Facility Name

Investigational Site Number 840025

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50702

Country

United States

Facility Name

Investigational Site Number 840022

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Investigational Site Number 840007

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Investigational Site Number 840081

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Investigational Site Number 840097

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

Investigational Site Number 840063

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 840028

City

Bloomfield Hills

State/Province

Michigan

Country

United States

Facility Name

Investigational Site Number 840071

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Investigational Site Number 840001

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

Investigational Site Number 840091

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

Investigational Site Number 840009

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Investigational Site Number 840024

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Investigational Site Number 840057

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Investigational Site Number 840042

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Investigational Site Number 840109

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Investigational Site Number 840052

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Investigational Site Number 840069

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

Investigational Site Number 840123

City

Morganville

State/Province

New Jersey

ZIP/Postal Code

07751

Country

United States

Facility Name

Investigational Site Number 840011

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Investigational Site Number 840030

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Investigational Site Number 840096

City

Syracuse

State/Province

New York

ZIP/Postal Code

13214-2016

Country

United States

Facility Name

Investigational Site Number 840039

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Investigational Site Number 840021

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Investigational Site Number 840046

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 840072

City

Morganton

State/Province

North Carolina

ZIP/Postal Code

28655

Country

United States

Facility Name

Investigational Site Number 840110

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Investigational Site Number 840095

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 840099

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840004

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Investigational Site Number 840016

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Investigational Site Number 840103

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

Investigational Site Number 840113

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201-3098

Country

United States

Facility Name

Investigational Site Number 840036

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15473

Country

United States

Facility Name

Investigational Site Number 840043

City

Tipton

State/Province

Pennsylvania

ZIP/Postal Code

16684

Country

United States

Facility Name

Investigational Site Number 840058

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Investigational Site Number 840127

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 840049

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Investigational Site Number 840114

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Investigational Site Number 840112

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Investigational Site Number 840094

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37912

Country

United States

Facility Name

Investigational Site Number 840051

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

Investigational Site Number 840066

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Investigational Site Number 840111

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

Investigational Site Number 840020

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Investigational Site Number 840064

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 840003

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 840088

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

Facility Name

Investigational Site Number 840118

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76132

Country

United States

Facility Name

Investigational Site Number 840055

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Investigational Site Number 840087

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Investigational Site Number 840079

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

Investigational Site Number 840073

City

N Richland Hill

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Investigational Site Number 840019

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 840037

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

Investigational Site Number 840093

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Investigational Site Number 840061

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Investigational Site Number 840041

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Investigational Site Number 840040

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23321

Country

United States

Facility Name

Investigational Site Number 840045

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Investigational Site Number 840092

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Investigational Site Number 840125

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Investigational Site Number 840115

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Investigational Site Number 840010

City

Weber City

State/Province

Virginia

ZIP/Postal Code

24290

Country

United States

Facility Name

Investigational Site Number 840077

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Investigational Site Number 840102

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

Facility Name

Investigational Site Number 840033

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209-0996

Country

United States

Facility Name

Investigational Site Number 036005

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Investigational Site Number 036001

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Investigational Site Number 036006

City

Kippa Ring

ZIP/Postal Code

4021

Country

Australia

Facility Name

Investigational Site Number 036007

City

Logan Central

ZIP/Postal Code

4114

Country

Australia

Facility Name

Investigational Site Number 056005

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Investigational Site Number 056006

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 124004

City

Kelowna

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Investigational Site Number 124001

City

Toronto

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Investigational Site Number 124002

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 152008

City

Osorno

ZIP/Postal Code

5311092

Country

Chile

Facility Name

Investigational Site Number 152015

City

Puerto Varas

Country

Chile

Facility Name

Investigational Site Number 152004

City

Santiago

ZIP/Postal Code

7500010

Country

Chile

Facility Name

Investigational Site Number 152006

City

Santiago

ZIP/Postal Code

7500010

Country

Chile

Facility Name

Investigational Site Number 152001

City

Santiago

ZIP/Postal Code

7591047

Country

Chile

Facility Name

Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

7980378

Country

Chile

Facility Name

Investigational Site Number 152012

City

Santiago

ZIP/Postal Code

8053095

Country

Chile

Facility Name

Investigational Site Number 152009

City

Santiago

ZIP/Postal Code

8330008

Country

Chile

Facility Name

Investigational Site Number 152011

City

Talagante

Country

Chile

Facility Name

Investigational Site Number 152014

City

Temuco

ZIP/Postal Code

4781156

Country

Chile

Facility Name

Investigational Site Number 152003

City

Temuco

ZIP/Postal Code

4813299

Country

Chile

Facility Name

Investigational Site Number 203004

City

Beroun

ZIP/Postal Code

26601

Country

Czech Republic

Facility Name

Investigational Site Number 203008

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czech Republic

Facility Name

Investigational Site Number 203014

City

Horovice

ZIP/Postal Code

26801

Country

Czech Republic

Facility Name

Investigational Site Number 203012

City

Koprivnice

ZIP/Postal Code

742 21

Country

Czech Republic

Facility Name

Investigational Site Number 203001

City

Pardubice

ZIP/Postal Code

53002

Country

Czech Republic

Facility Name

Investigational Site Number 203005

City

Plzen

ZIP/Postal Code

32600

Country

Czech Republic

Facility Name

Investigational Site Number 203003

City

Praha 10

ZIP/Postal Code

100 00

Country

Czech Republic

Facility Name

Investigational Site Number 203009

City

Praha 2

ZIP/Postal Code

12808

Country

Czech Republic

Facility Name

Investigational Site Number 203007

City

Praha 5

ZIP/Postal Code

15000

Country

Czech Republic

Facility Name

Investigational Site Number 203013

City

Praha 9 - Klanovice

ZIP/Postal Code

19014

Country

Czech Republic

Facility Name

Investigational Site Number 203006

City

Trutnov

ZIP/Postal Code

54101

Country

Czech Republic

Facility Name

Investigational Site Number 203016

City

Ujezd U Brna

Country

Czech Republic

Facility Name

Investigational Site Number 203015

City

Vsetin

ZIP/Postal Code

75501

Country

Czech Republic

Facility Name

Investigational Site Number 208003

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Investigational Site Number 208009

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

Facility Name

Investigational Site Number 208002

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Investigational Site Number 208001

City

København Nv

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Investigational Site Number 208005

City

København S

ZIP/Postal Code

2300

Country

Denmark

Facility Name

Investigational Site Number 208004

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Investigational Site Number 233004

City

Paide

ZIP/Postal Code

72713

Country

Estonia

Facility Name

Investigational Site Number 233002

City

Pärnu

ZIP/Postal Code

80018

Country

Estonia

Facility Name

Investigational Site Number 233003

City

Tallinn

ZIP/Postal Code

13415

Country

Estonia

Facility Name

Investigational Site Number 233001

City

Viljandimaa

ZIP/Postal Code

71024

Country

Estonia

Facility Name

Investigational Site Number 250006

City

Corbeil Essonnes

ZIP/Postal Code

91109

Country

France

Facility Name

Investigational Site Number 250002

City

La Rochelle Cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Investigational Site Number 250003

City

Pierre Benite

ZIP/Postal Code

69310

Country

France

Facility Name

Investigational Site Number 250001

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Investigational Site Number 276005

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Investigational Site Number 276003

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Investigational Site Number 276004

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Investigational Site Number 276007

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Investigational Site Number 276001

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 276006

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Investigational Site Number 276002

City

Neumünster

ZIP/Postal Code

24534

Country

Germany

Facility Name

Investigational Site Number 348003

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 348007

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348006

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

Investigational Site Number 348002

City

Budapest

ZIP/Postal Code

1138

Country

Hungary

Facility Name

Investigational Site Number 348011

City

Komárom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Investigational Site Number 348008

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Investigational Site Number 348010

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Investigational Site Number 348012

City

Sátoraljaújhely

ZIP/Postal Code

3980

Country

Hungary

Facility Name

Investigational Site Number 348001

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Investigational Site Number 380002

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Investigational Site Number 380006

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Investigational Site Number 380001

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 380003

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Investigational Site Number 380005

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Investigational Site Number 428002

City

Riga

ZIP/Postal Code

LV-1011

Country

Latvia

Facility Name

Investigational Site Number 428003

City

Riga

ZIP/Postal Code

LV-1011

Country

Latvia

Facility Name

Investigational Site Number 428004

City

Riga

ZIP/Postal Code

LV-1050

Country

Latvia

Facility Name

Investigational Site Number 428001

City

Sigulda

ZIP/Postal Code

LV-2150

Country

Latvia

Facility Name

Investigational Site Number 440003

City

Jonava

ZIP/Postal Code

LT-55201

Country

Lithuania

Facility Name

Investigational Site Number 440002

City

Kaunas

ZIP/Postal Code

LT-49456

Country

Lithuania

Facility Name

Investigational Site Number 440007

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Investigational Site Number 440004

City

Kedainiai

ZIP/Postal Code

LT-57164

Country

Lithuania

Facility Name

Investigational Site Number 440006

City

Panevezys

ZIP/Postal Code

LT-37355

Country

Lithuania

Facility Name

Investigational Site Number 440005

City

Utena

ZIP/Postal Code

LT-28151

Country

Lithuania

Facility Name

Investigational Site Number 440001

City

Vilnius

ZIP/Postal Code

LT-10323

Country

Lithuania

Facility Name

Investigational Site Number 484005

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Investigational Site Number 484001

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Investigational Site Number 484002

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Guadalajara

ZIP/Postal Code

44210

Country

Mexico

Facility Name

Investigational Site Number 484009

City

Guadalajara

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Investigational Site Number 484007

City

Monterrey

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Investigational Site Number 484006

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 484010

City

Zapopan

ZIP/Postal Code

45116

Country

Mexico

Facility Name

Investigational Site Number 616002

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Investigational Site Number 616005

City

Krakow

ZIP/Postal Code

31-261

Country

Poland

Facility Name

Investigational Site Number 616006

City

Krakow

ZIP/Postal Code

31-548

Country

Poland

Facility Name

Investigational Site Number 616007

City

Lodz

ZIP/Postal Code

94-074

Country

Poland

Facility Name

Investigational Site Number 616004

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

Investigational Site Number 616003

City

Warszawa

ZIP/Postal Code

01-518

Country

Poland

Facility Name

Investigational Site Number 616001

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 616008

City

Zory

ZIP/Postal Code

44-240

Country

Poland

Facility Name

Investigational Site Number 642008

City

Bucharest

ZIP/Postal Code

010825

Country

Romania

Facility Name

Investigational Site Number 642007

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Investigational Site Number 642009

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Investigational Site Number 642006

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 642005

City

Iasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

Investigational Site Number 642002

City

Oradea

ZIP/Postal Code

410169

Country

Romania

Facility Name

Investigational Site Number 642001

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 642004

City

Timisoara

ZIP/Postal Code

300133

Country

Romania

Facility Name

Investigational Site Number 642003

City

Timisoara

ZIP/Postal Code

300456

Country

Romania

Facility Name

Investigational Site Number 643006

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Investigational Site Number 643012

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

Saint-Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Facility Name

Investigational Site Number 643014

City

Samara

ZIP/Postal Code

443067

Country

Russian Federation

Facility Name

Investigational Site Number 643009

City

Saratov

ZIP/Postal Code

410026

Country

Russian Federation

Facility Name

Investigational Site Number 643011

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Investigational Site Number 643005

City

St-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Investigational Site Number 643007

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643002

City

St-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Investigational Site Number 643003

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Investigational Site Number 643016

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Investigational Site Number 643004

City

Voronezh

ZIP/Postal Code

394018

Country

Russian Federation

Facility Name

Investigational Site Number 710002

City

Cap Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Investigational Site Number 710003

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Investigational Site Number 710005

City

Meyerspark

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Investigational Site Number 710007

City

Port Elizabeth

Country

South Africa

Facility Name

Investigational Site Number 710004

City

Pretoria

ZIP/Postal Code

0122

Country

South Africa

Facility Name

Investigational Site Number 710001

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Investigational Site Number 710006

City

Soweto

ZIP/Postal Code

4309

Country

South Africa

Facility Name

Investigational Site Number 724012

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Investigational Site Number 724009

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

Investigational Site Number 724004

City

Hostalets De Balenyà

ZIP/Postal Code

08550

Country

Spain

Facility Name

Investigational Site Number 724011

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724007

City

Lugo

ZIP/Postal Code

27004

Country

Spain

Facility Name

Investigational Site Number 724008

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Investigational Site Number 724005

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Investigational Site Number 724013

City

Palma De Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Investigational Site Number 724001

City

Quart De Poblet

ZIP/Postal Code

46930

Country

Spain

Facility Name

Investigational Site Number 724006

City

Sant Joan Despí

ZIP/Postal Code

08970

Country

Spain

Facility Name

Investigational Site Number 724003

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Investigational Site Number 752001

City

Ljungby

ZIP/Postal Code

341 82

Country

Sweden

Facility Name

Investigational Site Number 752003

City

Malmö

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Investigational Site Number 752004

City

Rättvik

ZIP/Postal Code

79530

Country

Sweden

Facility Name

Investigational Site Number 752005

City

Stockholm

ZIP/Postal Code

11526

Country

Sweden

Facility Name

Investigational Site Number 752002

City

Vällingby

ZIP/Postal Code

16268

Country

Sweden

Facility Name

Investigational Site Number 804002

City

Chernivtsi

ZIP/Postal Code

58022

Country

Ukraine

Facility Name

Investigational Site Number 804009

City

Ivano-Frankovsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Investigational Site Number 804010

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Investigational Site Number 804007

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Investigational Site Number 804006

City

Kyiv

Country

Ukraine

Facility Name

Investigational Site Number 804012

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Investigational Site Number 804011

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Investigational Site Number 804008

City

Vinnytsya

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

Investigational Site Number 826001

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Investigational Site Number 826002

City

Dundee

ZIP/Postal Code

DD1 9SI

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

Norwich

ZIP/Postal Code

NR1 3SR

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27527848

Citation

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. Erratum In: Diabetes Care. 2017 Jun;40(6):809.

Results Reference

result

PubMed Identifier

35101326

Citation

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.

Results Reference

derived

PubMed Identifier

31124299

Citation

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.

Results Reference

derived

PubMed Identifier

31114694

Citation

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.

Results Reference

derived

PubMed Identifier

30550345

Citation

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.

Results Reference

derived

PubMed Identifier

29974618

Citation

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.

Results Reference

derived

PubMed Identifier

29923298

Citation

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.

Results Reference

derived

PubMed Identifier

28432746

Citation

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.

Results Reference

derived

Learn more about this trial

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

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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 (LixiLan-O)

Type 2 Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial