Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499082
First received: December 16, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

Primary Objective:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of Change in HbA1c from baseline to endpoint (scheduled month 6)

Secondary Objectives:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of Hypoglycemia


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Lantus (insulin glargine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose <= 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in variability of preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c < 7% at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with FPG < 100mg/dL at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point self-monitored plasma glucose profile [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in daily basal insulin dose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 807
Study Start Date: December 2011
Study Completion Date: September 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of insulin glargine
once daily on top of mealtime insulin with or without metformin
Drug: HOE901-U300 (new formulation of insulin glargine)
Pharmaceutical form:solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine)
once daily on top of mealtime insulin with or without metformin
Drug: Lantus (insulin glargine)
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus

Detailed Description:

The maximum study duration will be 58 weeks per patient, 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.
  • a 3-month administration substudy period starting after completion of the 6-month study period for patients willing to.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients 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 <18 years;
  • HbA1c <7.0% or >10% at screening;
  • Diabetes other than type 2 diabetes mellitus;
  • Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
  • Any contraindication to use of insulin glargine as defined in the national product label;
  • Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
  • Use of an insulin pump in the last 6 months before screening visit;
  • Initiation of new glucose-lowering agents and/or weight loss drugs 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:

    • Patient 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 patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499082

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Locations
United States, Arizona
Investigational Site Number 840156
Chandler, Arizona, United States, 85224
Investigational Site Number 840102
Glendale, Arizona, United States, 85306
Investigational Site Number 840071
Phoenix, Arizona, United States, 85028
Investigational Site Number 840121
Sun City, Arizona, United States, 85351
Investigational Site Number 840070
Tempe, Arizona, United States, 85282
United States, Arkansas
Investigational Site Number 840016
Hot Springs, Arkansas, United States, 71913
Investigational Site Number 840015
Little Rock, Arkansas, United States, 72205
Investigational Site Number 840124
Little Rock, Arkansas, United States, 72205
Investigational Site Number 840032
Searcy, Arkansas, United States, 72143
United States, California
Investigational Site Number 840076
Anaheim, California, United States, 92801
Investigational Site Number 840133
Encino, California, United States, 91436
Investigational Site Number 840062
Greenbrae, California, United States, 94904
Investigational Site Number 840057
Huntington Beach, California, United States, 92648
Investigational Site Number 840059
La Jolla, California, United States, 92037
Investigational Site Number 840004
La Mesa, California, United States, 91942
Investigational Site Number 840099
Mission Hills, California, United States, 91345
Investigational Site Number 840107
Palm Springs, California, United States, 92262
Investigational Site Number 840005
San Diego, California, United States, 92161
Investigational Site Number 840013
Tustin, California, United States, 92780
Investigational Site Number 840002
Walnut Creek, California, United States, 94598
United States, Colorado
Investigational Site Number 840136
Colorado Springs, Colorado, United States, 80910
Investigational Site Number 840114
Colorado Springs, Colorado, United States, 80906
Investigational Site Number 840092
Longmont, Colorado, United States, 80501
United States, Florida
Investigational Site Number 840049
Daytona Beach, Florida, United States, 32117
Investigational Site Number 840050
Hollywood, Florida, United States, 33021
Investigational Site Number 840011
Jacksonville, Florida, United States, 32216
Investigational Site Number 840086
Jacksonville, Florida, United States, 32204
Investigational Site Number 840009
Jacksonville, Florida, United States, 32258
Investigational Site Number 840023
New Port Richey, Florida, United States, 34652
Investigational Site Number 840012
Ocoee, Florida, United States, 34761
Investigational Site Number 840148
Palm Harbor, Florida, United States, 34684
United States, Georgia
Investigational Site Number 840055
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Investigational Site Number 840052
Idaho Falls, Idaho, United States, 83404
Investigational Site Number 840117
Nampa, Idaho, United States, 83686
United States, Illinois
Investigational Site Number 840020
Mchenry, Illinois, United States, 60050
Investigational Site Number 840019
Springfield, Illinois, United States, 62704
United States, Indiana
Investigational Site Number 840098
Avon, Indiana, United States, 46123
Investigational Site Number 840100
Avon, Indiana, United States, 46123
Investigational Site Number 840078
Avon, Indiana, United States, 46123
Investigational Site Number 840089
Avon, Indiana, United States, 46123
Investigational Site Number 840097
Avon, Indiana, United States, 46123
Investigational Site Number 840127
Vincennes, Indiana, United States, 47591
United States, Iowa
Investigational Site Number 840116
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 840003
Wichita, Kansas, United States, 67211
United States, Kentucky
Investigational Site Number 840080
Lexington, Kentucky, United States, 40504
Investigational Site Number 840042
Paducah, Kentucky, United States, 42003
United States, Maryland
Investigational Site Number 840036
Baltimore, Maryland, United States, 21237
Investigational Site Number 840155
Baltimore, Maryland, United States, 21237
Investigational Site Number 840034
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 840065
Ann Arbor, Michigan, United States, 48106
Investigational Site Number 840066
Dearborn, Michigan, United States, 48124
Investigational Site Number 840103
Flint, Michigan, United States, 48504
Investigational Site Number 840126
Kalamazoo, Michigan, United States, 49048
Investigational Site Number 840022
Southfield, Michigan, United States, 48034
United States, Minnesota
Investigational Site Number 840143
Chaska, Minnesota, United States, 55318
Investigational Site Number 840068
Eagan, Minnesota, United States, 55122
Investigational Site Number 840085
Minneapolis, Minnesota, United States, 55416
United States, Montana
Investigational Site Number 840053
Kalispell, Montana, United States, 59901
United States, Nebraska
Investigational Site Number 840090
Fremont, Nebraska, United States, 68025
Investigational Site Number 840091
Omaha, Nebraska, United States, 68130
United States, Nevada
Investigational Site Number 840058
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Investigational Site Number 840043
Brick, New Jersey, United States, 08274
Investigational Site Number 840152
Toms River, New Jersey, United States, 08721
United States, North Carolina
Investigational Site Number 840146
Asheville, North Carolina, United States, 28801
Investigational Site Number 840145
Hickory, North Carolina, United States, 28601
Investigational Site Number 840045
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Investigational Site Number 840067
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 840008
Cincinnati, Ohio, United States, 45236
Investigational Site Number 840106
Columbus, Ohio, United States, 43213
Investigational Site Number 840123
Dayton, Ohio, United States, 45439
Investigational Site Number 840119
Maumee, Ohio, United States, 43537
Investigational Site Number 840122
Mentor, Ohio, United States, 44060
United States, Oregon
Investigational Site Number 840083
Medford, Oregon, United States, 97504
Investigational Site Number 840084
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Investigational Site Number 840007
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Investigational Site Number 840079
Greer, South Carolina, United States, 29651
United States, South Dakota
Investigational Site Number 840048
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Investigational Site Number 840039
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840159
Knoxville, Tennessee, United States, 37912
United States, Texas
Investigational Site Number 840021
Austin, Texas, United States, 78731
Investigational Site Number 840081
Austin, Texas, United States, 78758
Investigational Site Number 840129
Austin, Texas, United States, 78731
Investigational Site Number 840047
Dallas, Texas, United States, 75246
Investigational Site Number 840001
Dallas, Texas, United States, 75230
Investigational Site Number 840082
Houston, Texas, United States, 77096
Investigational Site Number 840120
Hurst, Texas, United States, 76054
United States, Utah
Investigational Site Number 840010
Draper, Utah, United States, 84020
Investigational Site Number 840060
Ogden, Utah, United States, 84403
United States, Virginia
Investigational Site Number 840035
Chesapeake, Virginia, United States, 23321
Investigational Site Number 840041
Norfolk, Virginia, United States, 23510
Investigational Site Number 840074
Norfolk, Virginia, United States, 23502
Investigational Site Number 840112
Norfolk, Virginia, United States, 23507
Investigational Site Number 840104
Richmond, Virginia, United States, 23235
Investigational Site Number 840075
Williamsburg, Virginia, United States, 23185
United States, Wisconsin
Investigational Site Number 840018
Milwaukee, Wisconsin, United States, 53209-0996
Canada
Investigational Site Number 124024
Beamsville, Canada, L0R 1B0
Investigational Site Number 124025
Burlington, Canada, L7M 4Y1
Investigational Site Number 124023
Calgary, Canada, T2H 2G4
Investigational Site Number 124020
Calgary, Canada, T2N 4L7
Investigational Site Number 124019
Chatham, Canada, N7L 1C1
Investigational Site Number 124018
Coquitlam, Canada, V3K 3P4
Investigational Site Number 124021
Hamilton, Canada, L8L 5G8
Investigational Site Number 124014
Hamilton, Canada, L8N 3Z5
Investigational Site Number 124006
Laval, Canada, H7T 2P5
Investigational Site Number 124009
London, Canada, N6A 4V2
Investigational Site Number 124008
Mississauga, Canada, L5M 2V8
Investigational Site Number 124004
Montreal, Canada, H2W 1T8
Investigational Site Number 124015
Montreal, Canada, H2W 1R7
Investigational Site Number 124005
Oshawa, Canada, L1H 7K4
Investigational Site Number 124026
Quebec, Canada, G1V 4G5
Investigational Site Number 124002
Red Deer, Canada, T4N 6V7
Investigational Site Number 124007
Thornhill, Canada, L4J 8L7
Investigational Site Number 124001
Toronto, Canada, M4G 3E8
Investigational Site Number 124011
Toronto, Canada, M5C 2T2
Investigational Site Number 124010
Victoria, Canada, V8V 4A1
Investigational Site Number 124017
Ville St-Laurent, Canada, H4T 1Z9
Investigational Site Number 124022
Winnipeg, Canada, R3E 3P4
Czech Republic
Investigational Site Number 203006
Beroun, Czech Republic, 26601
Investigational Site Number 203001
Breclav, Czech Republic, 690 02
Investigational Site Number 203002
Hodonin, Czech Republic, 69501
Investigational Site Number 203009
Holesov, Czech Republic, 76901
Investigational Site Number 203003
Hradec Kralove, Czech Republic, 50005
Investigational Site Number 203007
Hranice, Czech Republic, 75301
Investigational Site Number 203004
Krnov, Czech Republic, 79401
Investigational Site Number 203010
Olomouc, Czech Republic, 77900
Investigational Site Number 203008
Praha 2, Czech Republic, 12808
Investigational Site Number 203005
Prostejov, Czech Republic, 79601
Estonia
Investigational Site Number 233002
Pärnu, Estonia, 80018
Investigational Site Number 233006
Tallinn, Estonia, 11913
Investigational Site Number 233003
Tallinn, Estonia, 13415
Investigational Site Number 233001
Tallinn, Estonia, 13419
Investigational Site Number 233004
Tallinn, Estonia, 11313
Investigational Site Number 233005
Tartu, Estonia, 50410
Finland
Investigational Site Number 246001
Helsinki, Finland, 00260
Investigational Site Number 246005
Kuopio, Finland, 70210
Investigational Site Number 246002
Oulu, Finland, 90100
France
Investigational Site Number 250004
La Rochelle Cedex, France, 17019
Investigational Site Number 250002
Strasbourg, France, 67091
Germany
Investigational Site Number 276006
Heidelberg, Germany, 69115
Investigational Site Number 276002
Riesa, Germany, 01587
Investigational Site Number 276003
Schwabenheim, Germany, 55270
Hungary
Investigational Site Number 348010
Baja, Hungary, 6500
Investigational Site Number 348004
Balatonfüred, Hungary, 8230
Investigational Site Number 348009
Budapest, Hungary, 1139
Investigational Site Number 348013
Budapest, Hungary, 1088
Investigational Site Number 348017
Budapest, Hungary, 1134
Investigational Site Number 348002
Budapest, Hungary
Investigational Site Number 348015
Budapest, Hungary, 1083
Investigational Site Number 348005
Debrecen, Hungary, 4043
Investigational Site Number 348008
Eger, Hungary, 3300
Investigational Site Number 348018
Gyula, Hungary, 5700
Investigational Site Number 348014
Makó, Hungary, 6900
Investigational Site Number 348012
Mosonmagyaróvár, Hungary, 9200
Investigational Site Number 348007
Nyiregyháza, Hungary, 4400
Investigational Site Number 348003
Szeged, Hungary, 6722
Investigational Site Number 348006
Szombathely, Hungary, 9700
Investigational Site Number 348011
Sátorlaljaújhely, Hungary, 3980
Investigational Site Number 348001
Zalaegerszeg, Hungary, 8900
Latvia
Investigational Site Number 428006
Jekabpils, Latvia, LV-5201
Investigational Site Number 428005
Ogre, Latvia, LV-5001
Investigational Site Number 428004
Riga, Latvia, LV-1050
Investigational Site Number 428001
Riga, Latvia, LV-1038
Investigational Site Number 428002
Riga, Latvia, LV-1002
Investigational Site Number 428003
Sigulda, Latvia, LV-2150
Mexico
Investigational Site Number 484007
Chihuahua, Mexico, 31000
Investigational Site Number 484001
Cuernavaca, Mexico, 62250
Investigational Site Number 484006
Guadalajara, Mexico, 44670
Investigational Site Number 484003
Monterrey, Mexico, 64460
Investigational Site Number 484004
Pachuca, Mexico, 42060
Netherlands
Investigational Site Number 528009
Almelo, Netherlands, 7609 PP
Investigational Site Number 528004
Eindhoven, Netherlands, 5631 BM
Investigational Site Number 528007
Groningen, Netherlands, 9728 NT
Investigational Site Number 528005
Hoogeveen, Netherlands, 7909 AA
Investigational Site Number 528001
Hoorn, Netherlands, 1064NP
Investigational Site Number 528008
Leeuwarden, Netherlands, 8934 AD
Investigational Site Number 528006
Utrecht, Netherlands, 3563 AZ
Investigational Site Number 528002
Venlo, Netherlands, 5912 BL
Romania
Investigational Site Number 642001
Bacau, Romania, 600114
Investigational Site Number 642005
Bucuresti, Romania, 020475
Investigational Site Number 642006
Bucuresti, Romania, 700164
Investigational Site Number 642002
Cluj Napoca, Romania, 400006
Investigational Site Number 642004
Iasi, Romania, 700547
Investigational Site Number 642008
Iasi, Romania, 700613
Investigational Site Number 642003
Oradea, Romania, 410169
Investigational Site Number 642009
Targu Mures, Romania, 540142
Investigational Site Number 642007
Timisoara, Romania, 300133
South Africa
Investigational Site Number 710005
Alberton, South Africa, 1450
Investigational Site Number 710003
Johannesburg, South Africa, 2198
Investigational Site Number 710006
Lenasia, South Africa, 1820
Investigational Site Number 710002
Observatory, South Africa, 7925
Investigational Site Number 710001
Paarl, South Africa, 7500
Investigational Site Number 710008
Pretoria, South Africa, 0167
Investigational Site Number 710004
Somerset West, South Africa, 7130
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01499082     History of Changes
Other Study ID Numbers: EFC11628, 2010-023769-23
Study First Received: December 16, 2011
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014