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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy (EDITION II)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lantus (Insulin glargine)
HOE901-U300 (new formulation of insulin glargine)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria :

  • Participants with type 2 diabetes mellitus

  • Substudy inclusion criteria:

    • Completion of the 6-month study period in main study (Visit 10)
    • Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)

Exclusion criteria:

  • Age less than (<) 18 years
  • HbA1c <7.0% or greater than (>) 10% at screening
  • Diabetes other than type 2 diabetes mellitus
  • Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
  • Participants using sulfonylurea in the last 2 months before screening visit
  • Any contraindication to use of insulin glargine as defined in the national product label
  • Use of insulin pump in the last 6 months before screening
  • Initiation of new glucose-lowering medications in the last 3 months before screening visit
  • History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study period

  • Substudy exclusion criteria:

    • Participant not willing to use the adaptable injection intervals on at least two days per week

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

Sites / Locations

  • Investigational Site Number 840517
  • Investigational Site Number 840149
  • Investigational Site Number 840093
  • Investigational Site Number 840069
  • Investigational Site Number 840110
  • Investigational Site Number 840068
  • Investigational Site Number 840015
  • Investigational Site Number 840014
  • Investigational Site Number 840114
  • Investigational Site Number 840018
  • Investigational Site Number 840027
  • Investigational Site Number 840074
  • Investigational Site Number 840509
  • Investigational Site Number 840060
  • Investigational Site Number 840057
  • Investigational Site Number 840003
  • Investigational Site Number 840026
  • Investigational Site Number 840090
  • Investigational Site Number 840099
  • Investigational Site Number 840004
  • Investigational Site Number 840124
  • Investigational Site Number 840012
  • Investigational Site Number 840104
  • Investigational Site Number 840128
  • Investigational Site Number 840098
  • Investigational Site Number 840518
  • Investigational Site Number 840049
  • Investigational Site Number 840008
  • Investigational Site Number 840520
  • Investigational Site Number 840025
  • Investigational Site Number 840011
  • Investigational Site Number 840141
  • Investigational Site Number 840513
  • Investigational Site Number 840528
  • Investigational Site Number 840050
  • Investigational Site Number 840107
  • Investigational Site Number 840199
  • Investigational Site Number 840021
  • Investigational Site Number 840020
  • Investigational Site Number 840045
  • Investigational Site Number 840077
  • Investigational Site Number 840088
  • Investigational Site Number 840089
  • Investigational Site Number 840091
  • Investigational Site Number 840130
  • Investigational Site Number 840142
  • Investigational Site Number 840041
  • Investigational Site Number 840034
  • Investigational Site Number 840150
  • Investigational Site Number 840031
  • Investigational Site Number 840063
  • Investigational Site Number 840064
  • Investigational Site Number 840094
  • Investigational Site Number 840023
  • Investigational Site Number 840066
  • Investigational Site Number 840081
  • Investigational Site Number 840158
  • Investigational Site Number 840526
  • Investigational Site Number 840502
  • Investigational Site Number 840084
  • Investigational Site Number 840085
  • Investigational Site Number 840162
  • Investigational Site Number 840527
  • Investigational Site Number 840056
  • Investigational Site Number 840135
  • Investigational Site Number 840145
  • Investigational Site Number 840087
  • Investigational Site Number 840140
  • Investigational Site Number 840139
  • Investigational Site Number 840153
  • Investigational Site Number 840047
  • Investigational Site Number 840024
  • Investigational Site Number 840065
  • Investigational Site Number 840007
  • Investigational Site Number 840097
  • Investigational Site Number 840113
  • Investigational Site Number 840108
  • Investigational Site Number 840504
  • Investigational Site Number 840080
  • Investigational Site Number 840148
  • Investigational Site Number 840005
  • Investigational Site Number 840076
  • Investigational Site Number 840503
  • Investigational Site Number 840048
  • Investigational Site Number 840028
  • Investigational Site Number 840038
  • Investigational Site Number 840042
  • Investigational Site Number 840160
  • Investigational Site Number 840033
  • Investigational Site Number 840022
  • Investigational Site Number 840078
  • Investigational Site Number 840519
  • Investigational Site Number 840001
  • Investigational Site Number 840159
  • Investigational Site Number 840115
  • Investigational Site Number 840079
  • Investigational Site Number 840514
  • Investigational Site Number 840525
  • Investigational Site Number 840161
  • Investigational Site Number 840009
  • Investigational Site Number 840037
  • Investigational Site Number 840510
  • Investigational Site Number 840032
  • Investigational Site Number 840040
  • Investigational Site Number 840095
  • Investigational Site Number 840072
  • Investigational Site Number 840134
  • Investigational Site Number 840523
  • Investigational Site Number 840122
  • Investigational Site Number 840019
  • Investigational Site Number 124024
  • Investigational Site Number 124025
  • Investigational Site Number 124020
  • Investigational Site Number 124019
  • Investigational Site Number 124018
  • Investigational Site Number 124016
  • Investigational Site Number 124014
  • Investigational Site Number 124004
  • Investigational Site Number 124026
  • Investigational Site Number 124002
  • Investigational Site Number 124013
  • Investigational Site Number 124011
  • Investigational Site Number 124010
  • Investigational Site Number 124022
  • Investigational Site Number 152014
  • Investigational Site Number 152012
  • Investigational Site Number 152005
  • Investigational Site Number 152004
  • Investigational Site Number 152003
  • Investigational Site Number 152001
  • Investigational Site Number 152013
  • Investigational Site Number 152002
  • Investigational Site Number 152007
  • Investigational Site Number 152010
  • Investigational Site Number 152006
  • Investigational Site Number 152009
  • Investigational Site Number 246001
  • Investigational Site Number 250001
  • Investigational Site Number 250004
  • Investigational Site Number 250005
  • Investigational Site Number 250002
  • Investigational Site Number 250009
  • Investigational Site Number 250003
  • Investigational Site Number 276004
  • Investigational Site Number 276003
  • Investigational Site Number 276008
  • Investigational Site Number 276009
  • Investigational Site Number 276007
  • Investigational Site Number 276005
  • Investigational Site Number 348006
  • Investigational Site Number 348005
  • Investigational Site Number 348003
  • Investigational Site Number 348010
  • Investigational Site Number 348009
  • Investigational Site Number 348002
  • Investigational Site Number 348001
  • Investigational Site Number 348008
  • Investigational Site Number 348004
  • Investigational Site Number 348007
  • Investigational Site Number 484009
  • Investigational Site Number 484007
  • Investigational Site Number 484008
  • Investigational Site Number 484010
  • Investigational Site Number 484006
  • Investigational Site Number 484001
  • Investigational Site Number 484003
  • Investigational Site Number 484004
  • Investigational Site Number 620007
  • Investigational Site Number 620004
  • Investigational Site Number 642008
  • Investigational Site Number 642009
  • Investigational Site Number 642003
  • Investigational Site Number 642001
  • Investigational Site Number 642002
  • Investigational Site Number 642014
  • Investigational Site Number 642006
  • Investigational Site Number 642011
  • Investigational Site Number 642015
  • Investigational Site Number 642013
  • Investigational Site Number 642010
  • Investigational Site Number 642004
  • Investigational Site Number 642007
  • Investigational Site Number 642012
  • Investigational Site Number 642005
  • Investigational Site Number 643010
  • Investigational Site Number 643007
  • Investigational Site Number 643011
  • Investigational Site Number 643002
  • Investigational Site Number 643009
  • Investigational Site Number 643006
  • Investigational Site Number 643014
  • Investigational Site Number 643013
  • Investigational Site Number 643004
  • Investigational Site Number 643001
  • Investigational Site Number 643008
  • Investigational Site Number 643016
  • Investigational Site Number 643005
  • Investigational Site Number 710007
  • Investigational Site Number 710006
  • Investigational Site Number 710014
  • Investigational Site Number 710002
  • Investigational Site Number 710003
  • Investigational Site Number 710010
  • Investigational Site Number 710001
  • Investigational Site Number 710005
  • Investigational Site Number 710012
  • Investigational Site Number 710008
  • Investigational Site Number 724005
  • Investigational Site Number 724003
  • Investigational Site Number 724006
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 724004

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.

Secondary Outcome Measures

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).

Full Information

First Posted
December 16, 2011
Last Updated
March 15, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01499095
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Acronym
EDITION II
Official Title
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
Detailed Description
The maximum study duration was up to approximately 58 weeks per participants, consisting of: up to 2 week screening period 6-month comparative efficacy and safety treatment period 6-month comparative safety extension period 4-week safety follow-up period in a subset of participants a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
811 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOE901-U300
Arm Type
Experimental
Arm Title
Lantus
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lantus (Insulin glargine)
Other Intervention Name(s)
Lantus
Intervention Description
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
Intervention Type
Drug
Intervention Name(s)
HOE901-U300 (new formulation of insulin glargine)
Intervention Description
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Month 6 Endpoint
Description
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Description
Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Week 9 Up to Month 6
Title
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Description
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Description
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Description
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Month 6
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Description
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Description
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Month 6
Title
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Description
Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Description
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Description
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
Description
Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).
Time Frame
Up to Month 12
Other Pre-specified Outcome Measures:
Title
Change in HbA1c From Month 6 to Month 9
Description
Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time Frame
Month 6 up to Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Participants with type 2 diabetes mellitus Substudy inclusion criteria: Completion of the 6-month study period in main study (Visit 10) Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6) Exclusion criteria: Age less than (<) 18 years HbA1c <7.0% or greater than (>) 10% at screening Diabetes other than type 2 diabetes mellitus Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose Participants using sulfonylurea in the last 2 months before screening visit Any contraindication to use of insulin glargine as defined in the national product label Use of insulin pump in the last 6 months before screening Initiation of new glucose-lowering medications in the last 3 months before screening visit History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period Pregnant or breast-feeding women or women who intend to become pregnant during the study period Substudy exclusion criteria: Participant not willing to use the adaptable injection intervals on at least two days per week 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 840517
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Investigational Site Number 840149
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigational Site Number 840093
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Investigational Site Number 840069
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Investigational Site Number 840110
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Investigational Site Number 840068
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigational Site Number 840015
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Investigational Site Number 840014
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840114
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840018
City
Mountain Home
State/Province
Arkansas
ZIP/Postal Code
72653
Country
United States
Facility Name
Investigational Site Number 840027
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
Investigational Site Number 840074
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigational Site Number 840509
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Investigational Site Number 840060
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 840057
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840003
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840026
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Investigational Site Number 840090
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigational Site Number 840099
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site Number 840004
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Investigational Site Number 840124
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Investigational Site Number 840012
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Investigational Site Number 840104
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Investigational Site Number 840128
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Investigational Site Number 840098
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Investigational Site Number 840518
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Investigational Site Number 840049
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Investigational Site Number 840008
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Investigational Site Number 840520
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Investigational Site Number 840025
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840011
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site Number 840141
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840513
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Investigational Site Number 840528
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Investigational Site Number 840050
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840107
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Investigational Site Number 840199
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number 840021
City
McHenry
State/Province
Illinois
ZIP/Postal Code
60050
Country
United States
Facility Name
Investigational Site Number 840020
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840045
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840077
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840088
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840089
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840091
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840130
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Investigational Site Number 840142
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Investigational Site Number 840041
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site Number 840034
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840150
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840031
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840063
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Investigational Site Number 840064
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Investigational Site Number 840094
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigational Site Number 840023
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Investigational Site Number 840066
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55122
Country
United States
Facility Name
Investigational Site Number 840081
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Investigational Site Number 840158
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Investigational Site Number 840526
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Investigational Site Number 840502
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site Number 840084
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Investigational Site Number 840085
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Investigational Site Number 840162
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigational Site Number 840527
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Investigational Site Number 840056
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site Number 840135
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Investigational Site Number 840145
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08721
Country
United States
Facility Name
Investigational Site Number 840087
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
Facility Name
Investigational Site Number 840140
City
Calabash
State/Province
North Carolina
ZIP/Postal Code
28467
Country
United States
Facility Name
Investigational Site Number 840139
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site Number 840153
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site Number 840047
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Investigational Site Number 840024
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number 840065
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840007
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Investigational Site Number 840097
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site Number 840113
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Investigational Site Number 840108
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Investigational Site Number 840504
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Investigational Site Number 840080
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Site Number 840148
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Investigational Site Number 840005
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Investigational Site Number 840076
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 840503
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Investigational Site Number 840048
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 840028
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Investigational Site Number 840038
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigational Site Number 840042
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Investigational Site Number 840160
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigational Site Number 840033
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Facility Name
Investigational Site Number 840022
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site Number 840078
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Investigational Site Number 840519
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Investigational Site Number 840001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840159
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840115
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840079
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 840514
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Investigational Site Number 840525
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 840161
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Investigational Site Number 840009
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Investigational Site Number 840037
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Investigational Site Number 840510
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Investigational Site Number 840032
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Investigational Site Number 840040
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Investigational Site Number 840095
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Investigational Site Number 840072
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Investigational Site Number 840134
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Investigational Site Number 840523
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Investigational Site Number 840122
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Investigational Site Number 840019
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Investigational Site Number 124024
City
Beamsville
ZIP/Postal Code
L0R 1B0
Country
Canada
Facility Name
Investigational Site Number 124025
City
Burlington
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Investigational Site Number 124020
City
Calgary
ZIP/Postal Code
T2N 4L7
Country
Canada
Facility Name
Investigational Site Number 124019
City
Chilliwack
ZIP/Postal Code
V2P 4M9
Country
Canada
Facility Name
Investigational Site Number 124018
City
Coquitlam
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Investigational Site Number 124016
City
Edmonton
ZIP/Postal Code
T5C 0A3
Country
Canada
Facility Name
Investigational Site Number 124014
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Investigational Site Number 124004
City
Mirabel
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Investigational Site Number 124026
City
Mississauga
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Investigational Site Number 124002
City
Red Deer
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Investigational Site Number 124013
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 124011
City
Toronto
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Investigational Site Number 124010
City
Victoria
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
Investigational Site Number 124022
City
Winnipeg
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Investigational Site Number 152014
City
Osorno
ZIP/Postal Code
5311092
Country
Chile
Facility Name
Investigational Site Number 152012
City
Rancagua
ZIP/Postal Code
2841959
Country
Chile
Facility Name
Investigational Site Number 152005
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Facility Name
Investigational Site Number 152004
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Investigational Site Number 152003
City
Santiago
ZIP/Postal Code
751-0009
Country
Chile
Facility Name
Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
7980378
Country
Chile
Facility Name
Investigational Site Number 152013
City
Santiago
ZIP/Postal Code
7980378
Country
Chile
Facility Name
Investigational Site Number 152002
City
Santiago
ZIP/Postal Code
80004005
Country
Chile
Facility Name
Investigational Site Number 152007
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Investigational Site Number 152010
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152006
City
Temuco
ZIP/Postal Code
4813299
Country
Chile
Facility Name
Investigational Site Number 152009
City
Valdivia
ZIP/Postal Code
56 63
Country
Chile
Facility Name
Investigational Site Number 246001
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Investigational Site Number 250001
City
La Rochelle Cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Investigational Site Number 250004
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Investigational Site Number 250005
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Investigational Site Number 250002
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 250009
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Investigational Site Number 250003
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Investigational Site Number 276004
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Investigational Site Number 276003
City
Neumünster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Investigational Site Number 276008
City
Oberhausen
ZIP/Postal Code
46045
Country
Germany
Facility Name
Investigational Site Number 276009
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Investigational Site Number 276007
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Investigational Site Number 276005
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Investigational Site Number 348006
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Investigational Site Number 348005
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Investigational Site Number 348010
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Investigational Site Number 348009
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Investigational Site Number 348002
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Investigational Site Number 348001
City
Makó
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Investigational Site Number 348008
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Pápa
ZIP/Postal Code
8500
Country
Hungary
Facility Name
Investigational Site Number 348007
City
Sátorlaljaújhely
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Investigational Site Number 484009
City
Acapulco
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Investigational Site Number 484007
City
Guadalajara
ZIP/Postal Code
44210
Country
Mexico
Facility Name
Investigational Site Number 484008
City
Guadalajara
ZIP/Postal Code
44656
Country
Mexico
Facility Name
Investigational Site Number 484010
City
Guadalajara
ZIP/Postal Code
Guadalajara
Country
Mexico
Facility Name
Investigational Site Number 484006
City
Mexico City
ZIP/Postal Code
11550
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Monterrey
ZIP/Postal Code
64240
Country
Mexico
Facility Name
Investigational Site Number 484004
City
Pachuca
ZIP/Postal Code
42060
Country
Mexico
Facility Name
Investigational Site Number 620007
City
Matosinhos
Country
Portugal
Facility Name
Investigational Site Number 620004
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Investigational Site Number 642008
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Investigational Site Number 642009
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Investigational Site Number 642003
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Investigational Site Number 642001
City
Bucuresti
ZIP/Postal Code
20475
Country
Romania
Facility Name
Investigational Site Number 642002
City
Bucuresti
ZIP/Postal Code
20475
Country
Romania
Facility Name
Investigational Site Number 642014
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Investigational Site Number 642006
City
Deva
ZIP/Postal Code
330084
Country
Romania
Facility Name
Investigational Site Number 642011
City
Hunedoara
ZIP/Postal Code
331057
Country
Romania
Facility Name
Investigational Site Number 642015
City
Iasi
ZIP/Postal Code
700547
Country
Romania
Facility Name
Investigational Site Number 642013
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642010
City
Ploiesti
ZIP/Postal Code
100097
Country
Romania
Facility Name
Investigational Site Number 642004
City
Resita
ZIP/Postal Code
320076
Country
Romania
Facility Name
Investigational Site Number 642007
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642012
City
Timisoara
ZIP/Postal Code
300133
Country
Romania
Facility Name
Investigational Site Number 642005
City
Timisoara
ZIP/Postal Code
300456
Country
Romania
Facility Name
Investigational Site Number 643010
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Investigational Site Number 643011
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Investigational Site Number 643009
City
St-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643014
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643013
City
St-Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
St-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
St-Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
St. Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Investigational Site Number 643016
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
Investigational Site Number 710007
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Investigational Site Number 710006
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710014
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Boksburg
ZIP/Postal Code
1459
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 710010
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 710001
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Investigational Site Number 710005
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Investigational Site Number 710012
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 710008
City
Umkomaas
ZIP/Postal Code
4170
Country
South Africa
Facility Name
Investigational Site Number 724005
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Investigational Site Number 724003
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724006
City
Palma De Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Investigational Site Number 724001
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number 724002
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Investigational Site Number 724004
City
Valancia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
25193531
Citation
Yki-Jarvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, Riddle MC; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.
Results Reference
result
PubMed Identifier
30366067
Citation
Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.
Results Reference
derived
PubMed Identifier
30160030
Citation
Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.
Results Reference
derived
PubMed Identifier
29649539
Citation
Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.
Results Reference
derived
PubMed Identifier
29370218
Citation
Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.
Results Reference
derived
PubMed Identifier
26172084
Citation
Yki-Jarvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, Maroccia M, Riddle MC. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015 Dec;17(12):1142-9. doi: 10.1111/dom.12532. Epub 2015 Sep 14.
Results Reference
derived

Learn more about this trial

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

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