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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-L)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin glargine/lixisenatide (HOE901/AVE0010)

Insulin glargine (HOE901)

Metformin (Background Drug)

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 :

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

Exclusion criteria:

Age under legal age of adulthood at screening visit.
HbA1c at screening visit less than 7.5% or above 10%.
Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.
Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.
History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.
Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.
Use of weight loss drugs within 3 months prior to screening visit.
Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.
At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).
Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.
Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.

Exclusion criteria for randomization:

HbA1c less than 7% or above 10% .
Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
Amylase and/or lipase more than 3 ULN .

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

Insulin glargine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

Change in Body Weight From Baseline to Week 30

Change in body weight 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

Change in Daily Insulin Glargine Dose From Baseline to 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).

Change in FPG From Baseline to Week 30

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

Change in 2-hour PPG From Baseline to Week 30

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

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

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

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

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

Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

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

Percentage of Participants With Documented Symptomatic Hypoglycemia

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

Percentage of Participants With Severe Symptomatic Hypoglycemia

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

Full Information

NCT ID

NCT02058160

First Posted

February 6, 2014

Last Updated

March 31, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02058160

Brief Title

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

Acronym

LixiLan-L

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 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 demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

Detailed Description

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

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

736 (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 100 U/mL QD for 30 weeks. Dose individually adjusted.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine/lixisenatide (HOE901/AVE0010)

Intervention Description

Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization. Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (HOE901)

Other Intervention Name(s)

Lantus

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin (Background Drug)

Intervention Description

Pharmaceutical form: Tablet; Route of administration: Oral administration

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 30

Title

Change in 2-hour Plasma Blood 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

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

Change in Daily Insulin Glargine Dose From Baseline to Week 30

Time Frame

Baseline, 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

Change in 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

Change in 2-hour PPG From Baseline to Week 30

Description

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

Time Frame

Baseline, Week 30

Title

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

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

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

Title

Percentage of Participants With Documented Symptomatic Hypoglycemia

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

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

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 [FRC], 210 days [Insulin glargine])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. Treatment with basal insulin for at least 6 months before the screening visit. Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit. For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of: metformin (more than or equal to 1500 mg/day or maximal tolerated dose), a sulfonylurea, a glinide, a dipeptidyl-peptidase-4 inhibitor, a sodium glucose co-transporter 2 inhibitor, Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit. Signed written informed consent. Exclusion criteria: Age under legal age of adulthood at screening visit. HbA1c at screening visit less than 7.5% or above 10%. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed. History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy. Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide. Use of weight loss drugs within 3 months prior to screening visit. Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit. At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2. At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN. At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). Any contraindication to metformin use, according to local labeling, if the participant was taking metformin. Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin. Exclusion criteria for randomization: HbA1c less than 7% or above 10% . Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L). Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit). Amylase and/or lipase more than 3 ULN . The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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 840607

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 840570

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Investigational Site Number 840562

City

Tempe

State/Province

Arizona

Country

United States

Facility Name

Investigational Site Number 840577

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85723

Country

United States

Facility Name

Investigational Site Number 840517

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 840537

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 840568

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

Investigational Site Number 840550

City

Chino

State/Province

California

ZIP/Postal Code

91710

Country

United States

Facility Name

Investigational Site Number 840529

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Investigational Site Number 840623

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Investigational Site Number 840566

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840552

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 840578

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Investigational Site Number 840626

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Investigational Site Number 840581

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 840621

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840511

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Investigational Site Number 840573

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Investigational Site Number 840559

City

Port Hueneme

State/Province

California

ZIP/Postal Code

93041

Country

United States

Facility Name

Investigational Site Number 840536

City

San Ramon

State/Province

California

ZIP/Postal Code

94583

Country

United States

Facility Name

Investigational Site Number 840567

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Investigational Site Number 840569

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Investigational Site Number 840572

City

West Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Investigational Site Number 840582

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Investigational Site Number 840509

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Investigational Site Number 840549

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Investigational Site Number 840510

City

Miami

State/Province

Florida

ZIP/Postal Code

33156-7563

Country

United States

Facility Name

Investigational Site Number 840521

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 840602

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Investigational Site Number 840538

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 840534

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840594

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Investigational Site Number 840614

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Investigational Site Number 840501

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Investigational Site Number 840525

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Investigational Site Number 840588

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Investigational Site Number 840580

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Investigational Site Number 840519

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 840612

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Investigational Site Number 840556

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Investigational Site Number 840543

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840565

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Investigational Site Number 840585

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840615

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840563

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Investigational Site Number 840507

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Investigational Site Number 840516

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Investigational Site Number 840595

City

Lewiston

State/Province

Maine

ZIP/Postal Code

04240

Country

United States

Facility Name

Investigational Site Number 840520

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 840560

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 840522

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 840505

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

Investigational Site Number 840575

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Investigational Site Number 840564

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Investigational Site Number 840558

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Investigational Site Number 840506

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Investigational Site Number 840600

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074

Country

United States

Facility Name

Investigational Site Number 840532

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Investigational Site Number 840599

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Investigational Site Number 840539

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

Investigational Site Number 840576

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Investigational Site Number 840583

City

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Investigational Site Number 840531

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Investigational Site Number 840557

City

Syracuse

State/Province

New York

ZIP/Postal Code

13214-2016

Country

United States

Facility Name

Investigational Site Number 840541

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Investigational Site Number 840604

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27858

Country

United States

Facility Name

Investigational Site Number 840540

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Investigational Site Number 840513

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 840592

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Investigational Site Number 840535

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 840515

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840579

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Investigational Site Number 840524

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

Investigational Site Number 840503

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Investigational Site Number 840618

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

Investigational Site Number 840610

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Investigational Site Number 840551

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

Country

United States

Facility Name

Investigational Site Number 840584

City

Tipton

State/Province

Pennsylvania

ZIP/Postal Code

16684

Country

United States

Facility Name

Investigational Site Number 840622

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 840611

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Investigational Site Number 840605

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Investigational Site Number 840553

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Investigational Site Number 840598

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Investigational Site Number 840502

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Investigational Site Number 840601

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

Investigational Site Number 840586

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Investigational Site Number 840547

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 840530

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 840545

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site Number 840554

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

Facility Name

Investigational Site Number 840544

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Investigational Site Number 840514

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

Investigational Site Number 840617

City

N Richland Hill

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Investigational Site Number 840512

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

Investigational Site Number 840591

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Investigational Site Number 840526

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Investigational Site Number 840597

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Investigational Site Number 840590

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Investigational Site Number 840613

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Investigational Site Number 840504

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23321

Country

United States

Facility Name

Investigational Site Number 840561

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Investigational Site Number 840625

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Investigational Site Number 840606

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23227

Country

United States

Facility Name

Investigational Site Number 840608

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Investigational Site Number 840571

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Investigational Site Number 840593

City

Spokane

State/Province

Washington

ZIP/Postal Code

99220

Country

United States

Facility Name

Investigational Site Number 840609

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98415-0299

Country

United States

Facility Name

Investigational Site Number 840546

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209-0996

Country

United States

Facility Name

Investigational Site Number 036505

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Investigational Site Number 036501

City

Heidelberg

ZIP/Postal Code

3081

Country

Australia

Facility Name

Investigational Site Number 036504

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Investigational Site Number 124504

City

Beamsville

ZIP/Postal Code

L0R 1B0

Country

Canada

Facility Name

Investigational Site Number 124512

City

Brampton

ZIP/Postal Code

L6R 3J5

Country

Canada

Facility Name

Investigational Site Number 124502

City

Guelph

ZIP/Postal Code

N1H 1B1

Country

Canada

Facility Name

Investigational Site Number 124507

City

Kelowna

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Investigational Site Number 124505

City

Montreal

ZIP/Postal Code

H1W 2R7

Country

Canada

Facility Name

Investigational Site Number 124511

City

Oakville

ZIP/Postal Code

L6H 3P1

Country

Canada

Facility Name

Investigational Site Number 124509

City

St-Romuald

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Investigational Site Number 124503

City

Toronto

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Investigational Site Number 124510

City

Toronto

ZIP/Postal Code

M9W 4L9

Country

Canada

Facility Name

Investigational Site Number 124501

City

Vancouver

ZIP/Postal Code

V5Y 3W2

Country

Canada

Facility Name

Investigational Site Number 124508

City

Victoria

ZIP/Postal Code

V8V 4A1

Country

Canada

Facility Name

Investigational Site Number 152511

City

Puerto Varas

ZIP/Postal Code

5480000

Country

Chile

Facility Name

Investigational Site Number 152502

City

Santiago

ZIP/Postal Code

7500347

Country

Chile

Facility Name

Investigational Site Number 152501

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Investigational Site Number 152514

City

Santiago

ZIP/Postal Code

7500739

Country

Chile

Facility Name

Investigational Site Number 152503

City

Santiago

ZIP/Postal Code

8053095

Country

Chile

Facility Name

Investigational Site Number 152507

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 152509

City

Talagante

Country

Chile

Facility Name

Investigational Site Number 152513

City

Temuco

ZIP/Postal Code

4780000

Country

Chile

Facility Name

Investigational Site Number 152504

City

Vina Del Mar

Country

Chile

Facility Name

Investigational Site Number 203502

City

Cheb

ZIP/Postal Code

35002

Country

Czech Republic

Facility Name

Investigational Site Number 203504

City

Hranice

ZIP/Postal Code

75301

Country

Czech Republic

Facility Name

Investigational Site Number 203507

City

Krnov

ZIP/Postal Code

79401

Country

Czech Republic

Facility Name

Investigational Site Number 203506

City

Liberec

ZIP/Postal Code

460 01

Country

Czech Republic

Facility Name

Investigational Site Number 203503

City

Olomouc

ZIP/Postal Code

77900

Country

Czech Republic

Facility Name

Investigational Site Number 203514

City

Plzen

ZIP/Postal Code

301 66

Country

Czech Republic

Facility Name

Investigational Site Number 203515

City

Plzen

ZIP/Postal Code

301 66

Country

Czech Republic

Facility Name

Investigational Site Number 203511

City

Praha 4

ZIP/Postal Code

14900

Country

Czech Republic

Facility Name

Investigational Site Number 203508

City

Praha 5

ZIP/Postal Code

15030

Country

Czech Republic

Facility Name

Investigational Site Number 203509

City

Praha 8

ZIP/Postal Code

18100

Country

Czech Republic

Facility Name

Investigational Site Number 203505

City

Prostejov

ZIP/Postal Code

79601

Country

Czech Republic

Facility Name

Investigational Site Number 208503

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Investigational Site Number 208509

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

Facility Name

Investigational Site Number 208502

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Investigational Site Number 208501

City

København Nv

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Investigational Site Number 208505

City

København S

ZIP/Postal Code

2300

Country

Denmark

Facility Name

Investigational Site Number 208504

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Investigational Site Number 233502

City

Pärnu

ZIP/Postal Code

80018

Country

Estonia

Facility Name

Investigational Site Number 233503

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Investigational Site Number 233501

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Investigational Site Number 348503

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Investigational Site Number 348501

City

Budapest

ZIP/Postal Code

1138

Country

Hungary

Facility Name

Investigational Site Number 348505

City

Budapest

ZIP/Postal Code

1212

Country

Hungary

Facility Name

Investigational Site Number 348502

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Investigational Site Number 348506

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Investigational Site Number 348504

City

Pápa

ZIP/Postal Code

8500

Country

Hungary

Facility Name

Investigational Site Number 440501

City

Kaunas

ZIP/Postal Code

48259

Country

Lithuania

Facility Name

Investigational Site Number 440503

City

Kaunas

ZIP/Postal Code

49449

Country

Lithuania

Facility Name

Investigational Site Number 440505

City

Kedainiai

ZIP/Postal Code

LT-57164

Country

Lithuania

Facility Name

Investigational Site Number 440504

City

Klaipeda

ZIP/Postal Code

LT-92253

Country

Lithuania

Facility Name

Investigational Site Number 440502

City

Vilnius

ZIP/Postal Code

LT-10323

Country

Lithuania

Facility Name

Investigational Site Number 484508

City

Celaya

ZIP/Postal Code

38000

Country

Mexico

Facility Name

Investigational Site Number 484501

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Investigational Site Number 484503

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Investigational Site Number 484504

City

Guadalajara

ZIP/Postal Code

44210

Country

Mexico

Facility Name

Investigational Site Number 484506

City

Guadalajara

ZIP/Postal Code

44600

Country

Mexico

Facility Name

Investigational Site Number 484509

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 484507

City

Pachuca

ZIP/Postal Code

42084

Country

Mexico

Facility Name

Investigational Site Number 484505

City

Puebla

ZIP/Postal Code

72190

Country

Mexico

Facility Name

Investigational Site Number 528505

City

Almere

ZIP/Postal Code

1311 RL

Country

Netherlands

Facility Name

Investigational Site Number 616502

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Investigational Site Number 616505

City

Krakow

ZIP/Postal Code

31-261

Country

Poland

Facility Name

Investigational Site Number 616506

City

Krakow

ZIP/Postal Code

31-548

Country

Poland

Facility Name

Investigational Site Number 616507

City

Plock

ZIP/Postal Code

09-400

Country

Poland

Facility Name

Investigational Site Number 616504

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

Investigational Site Number 616503

City

Warszawa

ZIP/Postal Code

01-518

Country

Poland

Facility Name

Investigational Site Number 616501

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 642507

City

Brasov

ZIP/Postal Code

500365

Country

Romania

Facility Name

Investigational Site Number 642510

City

Bucharest

ZIP/Postal Code

010825

Country

Romania

Facility Name

Investigational Site Number 642508

City

Bucuresti

ZIP/Postal Code

020042

Country

Romania

Facility Name

Investigational Site Number 642509

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Investigational Site Number 642506

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 642505

City

Iasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

Investigational Site Number 642502

City

Oradea

ZIP/Postal Code

410169

Country

Romania

Facility Name

Investigational Site Number 642511

City

Sibiu

ZIP/Postal Code

550371

Country

Romania

Facility Name

Investigational Site Number 642501

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 642504

City

Timisoara

ZIP/Postal Code

300125

Country

Romania

Facility Name

Investigational Site Number 642503

City

Timisoara

ZIP/Postal Code

300456

Country

Romania

Facility Name

Investigational Site Number 643511

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Investigational Site Number 643512

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Investigational Site Number 643508

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Investigational Site Number 643501

City

Saint-Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Facility Name

Investigational Site Number 643513

City

Samara

ZIP/Postal Code

443041

Country

Russian Federation

Facility Name

Investigational Site Number 643507

City

Saratov

ZIP/Postal Code

410030

Country

Russian Federation

Facility Name

Investigational Site Number 643514

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Investigational Site Number 643506

City

St-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Investigational Site Number 643503

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643504

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643502

City

St-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Investigational Site Number 643505

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Investigational Site Number 643509

City

Voronezh

ZIP/Postal Code

394018

Country

Russian Federation

Facility Name

Investigational Site Number 703505

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Investigational Site Number 703507

City

Bytca

ZIP/Postal Code

01401

Country

Slovakia

Facility Name

Investigational Site Number 703502

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Investigational Site Number 703512

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Investigational Site Number 703510

City

Kosice

ZIP/Postal Code

04013

Country

Slovakia

Facility Name

Investigational Site Number 703511

City

Lubochna

ZIP/Postal Code

3491

Country

Slovakia

Facility Name

Investigational Site Number 703508

City

Moldava Nad Bodvou

ZIP/Postal Code

04525

Country

Slovakia

Facility Name

Investigational Site Number 703504

City

Nove Mesto Nad Vahom

ZIP/Postal Code

91501

Country

Slovakia

Facility Name

Investigational Site Number 703509

City

Nove Zamky

ZIP/Postal Code

94001

Country

Slovakia

Facility Name

Investigational Site Number 703513

City

Trnava

ZIP/Postal Code

91701

Country

Slovakia

Facility Name

Investigational Site Number 703501

City

Zilina

ZIP/Postal Code

01001

Country

Slovakia

Facility Name

Investigational Site Number 724509

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Investigational Site Number 724506

City

Alzira

ZIP/Postal Code

46600

Country

Spain

Facility Name

Investigational Site Number 724504

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 724510

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 724505

City

Cáceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Investigational Site Number 724503

City

El Ferrol

ZIP/Postal Code

15405

Country

Spain

Facility Name

Investigational Site Number 724508

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724501

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724507

City

Segovia

ZIP/Postal Code

40002

Country

Spain

Facility Name

Investigational Site Number 724502

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Investigational Site Number 752501

City

Ljungby

ZIP/Postal Code

341 82

Country

Sweden

Facility Name

Investigational Site Number 752503

City

Malmö

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Investigational Site Number 752504

City

Rättvik

ZIP/Postal Code

79530

Country

Sweden

Facility Name

Investigational Site Number 752506

City

Stenungssund

ZIP/Postal Code

44431

Country

Sweden

Facility Name

Investigational Site Number 752505

City

Stockholm

ZIP/Postal Code

11526

Country

Sweden

Facility Name

Investigational Site Number 752502

City

Vällingby

ZIP/Postal Code

16268

Country

Sweden

Facility Name

Investigational Site Number 804501

City

Chernivtsi

ZIP/Postal Code

58022

Country

Ukraine

Facility Name

Investigational Site Number 804510

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Investigational Site Number 804507

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Investigational Site Number 804511

City

Kyiv

Country

Ukraine

Facility Name

Investigational Site Number 804513

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Investigational Site Number 804502

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Investigational Site Number 804508

City

Vinnytsya

ZIP/Postal Code

21010

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

27650977

Citation

Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, Gonzalez-Galvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L Trial Investigators. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20. Erratum In: Diabetes Care. 2017 Jun;40(6):809.

Results Reference

result

PubMed Identifier

31848983

Citation

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

Results Reference

derived

PubMed Identifier

31359368

Citation

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

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

30218434

Citation

Zisman A, Dex T, Roberts M, Saremi A, Chao J, Aroda VR. Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Oct;9(5):2155-2162. doi: 10.1007/s13300-018-0507-0. Epub 2018 Sep 14. Erratum In: Diabetes Ther. 2018 Dec 4;:

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

29143919

Citation

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

Results Reference

derived

PubMed Identifier

28386990

Citation

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

Results Reference

derived

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

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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-L)

Type 2 Diabetes

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