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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499095
First received: December 16, 2011
Last updated: May 7, 2014
Last verified: May 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 Objective:

- 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: Lantus (Insulin glargine)
Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Oral Antidiabetics
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 in Combination With Oral Antihyperglycemic Drug(s) 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: No ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 811
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of insulin glargine
once daily on top of oral antidiabetic drugs
Drug: HOE901-U300 (new formulation of insulin glargine)

Pharmaceutical form:solution

Route of administration: subcutaneous

Drug: Oral Antidiabetics
Patients are enrolled with an oral antihyperglycemic background therapy taken at a stable dose for at least 3 months prior to the screening visit. The doses and combinations used are to be according to the authorized local labeling. Doses should be kept stable throughout the study.
Active Comparator: Lantus (insulin glargine)
once daily on top of oral antidiabetic drugs
Drug: Lantus (Insulin glargine)

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Name: Lantus
Drug: Oral Antidiabetics
Patients are enrolled with an oral antihyperglycemic background therapy taken at a stable dose for at least 3 months prior to the screening visit. The doses and combinations used are to be according to the authorized local labeling. Doses should be kept stable throughout the study.

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 :

o 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 6 months on basal insulin treatment together with oral antihyperglycemic drugs and self-monitoring of blood glucose;
  • Patients 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:

o 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: NCT01499095

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01499095     History of Changes
Other Study ID Numbers: EFC11629, 2010-023770-39, U1111-1118-6943
Study First Received: December 16, 2011
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014