search
Back to results

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

Primary Purpose

Type 1 Diabetes Mellitus

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

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria:

  • Adult participants with type 1 diabetes mellitus

Exclusion criteria:

  • HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening
  • Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
  • Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
  • Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
  • Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
  • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period

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 840156
  • Investigational Site Number 840177
  • Investigational Site Number 840430
  • Investigational Site Number 840131
  • Investigational Site Number 840140
  • Investigational Site Number 840107
  • Investigational Site Number 840149
  • Investigational Site Number 840120
  • Investigational Site Number 840123
  • Investigational Site Number 840159
  • Investigational Site Number 840114
  • Investigational Site Number 840189
  • Investigational Site Number 840105
  • Investigational Site Number 840155
  • Investigational Site Number 840115
  • Investigational Site Number 840160
  • Investigational Site Number 840188
  • Investigational Site Number 840196
  • Investigational Site Number 840113
  • Investigational Site Number 840102
  • Investigational Site Number 840134
  • Investigational Site Number 840185
  • Investigational Site Number 840116
  • Investigational Site Number 840126
  • Investigational Site Number 840179
  • Investigational Site Number 840117
  • Investigational Site Number 840174
  • Investigational Site Number 840110
  • Investigational Site Number 840178
  • Investigational Site Number 840181
  • Investigational Site Number 840420
  • Investigational Site Number 840195
  • Investigational Site Number 840124
  • Investigational Site Number 840167
  • Investigational Site Number 840163
  • Investigational Site Number 840162
  • Investigational Site Number 840172
  • Investigational Site Number 840197
  • Investigational Site Number 840108
  • Investigational Site Number 840407
  • Investigational Site Number 840170
  • Investigational Site Number 840421
  • Investigational Site Number 840426
  • Investigational Site Number 840104
  • Investigational Site Number 840180
  • Investigational Site Number 840137
  • Investigational Site Number 840408
  • Investigational Site Number 840153
  • Investigational Site Number 840171
  • Investigational Site Number 840184
  • Investigational Site Number 840106
  • Investigational Site Number 840145
  • Investigational Site Number 840139
  • Investigational Site Number 840151
  • Investigational Site Number 840191
  • Investigational Site Number 840173
  • Investigational Site Number 840133
  • Investigational Site Number 840175
  • Investigational Site Number 840161
  • Investigational Site Number 840169
  • Investigational Site Number 840119
  • Investigational Site Number 840112
  • Investigational Site Number 840136
  • Investigational Site Number 840122
  • Investigational Site Number 840144
  • Investigational Site Number 840187
  • Investigational Site Number 840109
  • Investigational Site Number 840157
  • Investigational Site Number 840150
  • Investigational Site Number 840412
  • Investigational Site Number 840130
  • Investigational Site Number 840141
  • Investigational Site Number 840166
  • Investigational Site Number 840101
  • Investigational Site Number 840125
  • Investigational Site Number 840427
  • Investigational Site Number 840103
  • Investigational Site Number 840132
  • Investigational Site Number 840403
  • Investigational Site Number 840402
  • Investigational Site Number 840127
  • Investigational Site Number 840411
  • Investigational Site Number 124110
  • Investigational Site Number 124104
  • Investigational Site Number 124108
  • Investigational Site Number 124109
  • Investigational Site Number 124105
  • Investigational Site Number 124101
  • Investigational Site Number 203102
  • Investigational Site Number 203104
  • Investigational Site Number 203103
  • Investigational Site Number 208103
  • Investigational Site Number 208105
  • Investigational Site Number 208104
  • Investigational Site Number 208107
  • Investigational Site Number 208102
  • Investigational Site Number 233104
  • Investigational Site Number 233105
  • Investigational Site Number 233106
  • Investigational Site Number 233101
  • Investigational Site Number 233103
  • Investigational Site Number 246102
  • Investigational Site Number 246101
  • Investigational Site Number 246106
  • Investigational Site Number 246105
  • Investigational Site Number 246103
  • Investigational Site Number 348103
  • Investigational Site Number 348108
  • Investigational Site Number 348107
  • Investigational Site Number 348106
  • Investigational Site Number 348102
  • Investigational Site Number 348101
  • Investigational Site Number 392110
  • Investigational Site Number 392105
  • Investigational Site Number 392104
  • Investigational Site Number 392111
  • Investigational Site Number 392112
  • Investigational Site Number 392108
  • Investigational Site Number 392103
  • Investigational Site Number 392107
  • Investigational Site Number 392101
  • Investigational Site Number 392102
  • Investigational Site Number 392106
  • Investigational Site Number 428106
  • Investigational Site Number 428103
  • Investigational Site Number 428105
  • Investigational Site Number 428102
  • Investigational Site Number 428101
  • Investigational Site Number 528101
  • Investigational Site Number 528103
  • Investigational Site Number 528105
  • Investigational Site Number 528104
  • Investigational Site Number 528102
  • Investigational Site Number 840602
  • Investigational Site Number 642107
  • Investigational Site Number 642103
  • Investigational Site Number 642109
  • Investigational Site Number 642106
  • Investigational Site Number 642104
  • Investigational Site Number 642101
  • Investigational Site Number 642102
  • Investigational Site Number 642105
  • Investigational Site Number 642108
  • Investigational Site Number 752103
  • Investigational Site Number 752105
  • Investigational Site Number 752101
  • Investigational Site Number 752104

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Outcomes

Primary Outcome Measures

Change In HbA1c From Baseline to Month 6 Endpoint

Secondary Outcome Measures

Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
Pre-injection 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.
Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
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.
Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
Change in Total 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.
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
September 7, 2012
Last Updated
May 28, 2015
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01683266
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Acronym
EDITION IV
Official Title
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2014 (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 a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: Change of HbA1c from baseline to endpoint (scheduled Month 6) Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Detailed Description
The maximum study duration was up to approximately 54 weeks per participants: Up to 2-week screening period 6-month open-label comparative efficacy and safety treatment period 6-month open-label comparative safety extension period 48-hour 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 1 Diabetes Mellitus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HOE901-U300
Arm Type
Experimental
Arm Description
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
Arm Title
Lantus
Arm Type
Active Comparator
Arm Description
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
Intervention Type
Drug
Intervention Name(s)
HOE901-U300 (Insulin glargine new formulation)
Intervention Type
Drug
Intervention Name(s)
Lantus (Insulin glargine)
Primary Outcome Measure Information:
Title
Change In HbA1c From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Time Frame
Month 6
Title
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
Time Frame
Month 6
Title
Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
Description
Pre-injection 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.
Time Frame
Baseline, Month 6
Title
Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
Description
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Time Frame
Baseline, Month 6
Title
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Title
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
Time Frame
Month 6
Title
Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
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.
Time Frame
Baseline, Month 6
Title
Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Title
Change in Total 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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Adult participants with type 1 diabetes mellitus Exclusion criteria: HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening; Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period 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 840156
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigational Site Number 840177
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840430
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Investigational Site Number 840131
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Investigational Site Number 840140
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840107
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 840149
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Investigational Site Number 840120
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840123
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840159
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840114
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigational Site Number 840189
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigational Site Number 840105
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Investigational Site Number 840155
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Investigational Site Number 840115
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Investigational Site Number 840160
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Investigational Site Number 840188
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 840196
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Investigational Site Number 840113
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Investigational Site Number 840102
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigational Site Number 840134
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigational Site Number 840185
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840116
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Investigational Site Number 840126
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Investigational Site Number 840179
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigational Site Number 840117
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840174
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840110
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Investigational Site Number 840178
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840181
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Investigational Site Number 840420
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Investigational Site Number 840195
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Investigational Site Number 840124
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Investigational Site Number 840167
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840163
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Investigational Site Number 840162
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840172
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840197
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Site Number 840108
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Investigational Site Number 840407
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Investigational Site Number 840170
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigational Site Number 840421
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Investigational Site Number 840426
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number 840104
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840180
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840137
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
1830
Country
United States
Facility Name
Investigational Site Number 840408
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Investigational Site Number 840153
City
Madison Heights
State/Province
Michigan
ZIP/Postal Code
48071
Country
United States
Facility Name
Investigational Site Number 840171
City
St Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Investigational Site Number 840184
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 840106
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840145
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840139
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site Number 840151
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Investigational Site Number 840191
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Investigational Site Number 840173
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Investigational Site Number 840133
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Investigational Site Number 840175
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Investigational Site Number 840161
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Investigational Site Number 840169
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Investigational Site Number 840119
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Investigational Site Number 840112
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Investigational Site Number 840136
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 840122
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Investigational Site Number 840144
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigational Site Number 840187
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Investigational Site Number 840109
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site Number 840157
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site Number 840150
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840412
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840130
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 840141
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Investigational Site Number 840166
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 840101
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Investigational Site Number 840125
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Investigational Site Number 840427
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Investigational Site Number 840103
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Investigational Site Number 840132
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Investigational Site Number 840403
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Investigational Site Number 840402
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
Facility Name
Investigational Site Number 840127
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415-0299
Country
United States
Facility Name
Investigational Site Number 840411
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Investigational Site Number 124110
City
Coquitlam
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Investigational Site Number 124104
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 124108
City
Mirabel
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Investigational Site Number 124109
City
Montreal
ZIP/Postal Code
H1Y 3L1
Country
Canada
Facility Name
Investigational Site Number 124105
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Investigational Site Number 124101
City
Toronto
ZIP/Postal Code
M4R 2G4
Country
Canada
Facility Name
Investigational Site Number 203102
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Investigational Site Number 203104
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Investigational Site Number 203103
City
Praha 8
ZIP/Postal Code
18100
Country
Czech Republic
Facility Name
Investigational Site Number 208103
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number 208105
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 208104
City
København Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number 208107
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Investigational Site Number 208102
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Investigational Site Number 233104
City
Pärnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Investigational Site Number 233105
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 233106
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Investigational Site Number 233101
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
Investigational Site Number 233103
City
Viljandimaa
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Investigational Site Number 246102
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Investigational Site Number 246101
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Investigational Site Number 246106
City
Loimaa
ZIP/Postal Code
32200
Country
Finland
Facility Name
Investigational Site Number 246105
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Investigational Site Number 246103
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigational Site Number 348103
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site Number 348108
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Investigational Site Number 348107
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Investigational Site Number 348106
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Investigational Site Number 348102
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigational Site Number 348101
City
Urhida
ZIP/Postal Code
8142
Country
Hungary
Facility Name
Investigational Site Number 392110
City
Aisai-Shi
Country
Japan
Facility Name
Investigational Site Number 392105
City
Ise-Shi
Country
Japan
Facility Name
Investigational Site Number 392104
City
Karatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392111
City
Kitakyushu-Shi
Country
Japan
Facility Name
Investigational Site Number 392112
City
Matsumoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392108
City
Matumoto
Country
Japan
Facility Name
Investigational Site Number 392103
City
Midori-Shi
Country
Japan
Facility Name
Investigational Site Number 392107
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392101
City
Sakai-Shi
Country
Japan
Facility Name
Investigational Site Number 392102
City
Tomishiro
Country
Japan
Facility Name
Investigational Site Number 392106
City
Yamagata-Shi
Country
Japan
Facility Name
Investigational Site Number 428106
City
Limbazi
ZIP/Postal Code
LV-4001
Country
Latvia
Facility Name
Investigational Site Number 428103
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 428105
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Facility Name
Investigational Site Number 428102
City
Sigulda
ZIP/Postal Code
LV-2150
Country
Latvia
Facility Name
Investigational Site Number 428101
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Investigational Site Number 528101
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
Investigational Site Number 528103
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Investigational Site Number 528105
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Investigational Site Number 528104
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Investigational Site Number 528102
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Investigational Site Number 840602
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Investigational Site Number 642107
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Investigational Site Number 642103
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Investigational Site Number 642109
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642106
City
Resita
ZIP/Postal Code
320076
Country
Romania
Facility Name
Investigational Site Number 642104
City
Sibiu
ZIP/Postal Code
550371
Country
Romania
Facility Name
Investigational Site Number 642101
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642102
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642105
City
Timisoara
ZIP/Postal Code
300133
Country
Romania
Facility Name
Investigational Site Number 642108
City
Timisoara
ZIP/Postal Code
300456
Country
Romania
Facility Name
Investigational Site Number 752103
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Investigational Site Number 752105
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
Facility Name
Investigational Site Number 752101
City
Stockholm
ZIP/Postal Code
11526
Country
Sweden
Facility Name
Investigational Site Number 752104
City
Vällingby
ZIP/Postal Code
16268
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28661585
Citation
Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.
Results Reference
derived

Learn more about this trial

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

We'll reach out to this number within 24 hrs