Recruitment

Recruitment Status
Completed
Estimated Enrollment
700

Inclusion Criteria

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

Exclusion Criteria

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

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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

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

Inclusion Criteria

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

Exclusion Criteria

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

Locations

Dallas, Texas, 75230
St-Romuald, G6W 5M6
Victoria, V8V 4A1
Parkville, 3050
Draper, Utah, 84020
...
Dallas, Texas, 75230
St-Romuald, G6W 5M6
Victoria, V8V 4A1
Parkville, 3050
Draper, Utah, 84020
Sabadell, 08208
Nove Zamky, 94001
Trnava, 91701
Chicago, Illinois, 60607
New Hyde Park, New York, 11042
Santa Ana, California, 92704
Santiago
Burlington, Vermont, 05401
Nashua, New Hampshire, 03063
Alicante, 03010
Talagante
Eugene, Oregon, 97404
Saint-Petersburg, 190013
Heidelberg, 3081
Kaposvár, 7400
Minneapolis, Minnesota, 55416
Kolding, 6000
Kaunas, 48259
Tarzana, California, 91356
Cáceres, 10003
Mission Viejo, California, 92691
Brampton, L6R 3J5
Bucharest, 010825
Bialystok, 15-435
Targu Mures, 540142
Las Vegas, Nevada, 89148
Horsens, 8700
Brasov, 500365
Arkhangelsk, 163045
Almere, 1311 RL
Murray, Utah, 84123
Segovia, 40002
Penza, 440026
Las Vegas, Nevada, 89119
Amarillo, Texas, 79106
Puerto Varas, 5480000
Bytca, 01401
Edinburg, Texas, 78539
Timisoara, 300125
Columbus, Georgia, 31904
Warszawa, 02-507
Miami, Florida, 33156-7563
Maumee, Ohio, 43537
Kosice, 04001
Chernivtsi, 58022
Idaho Falls, Idaho, 83404
Ocala, Florida, 34471
Beamsville, L0R 1B0
Vällingby, 16268
Krakow, 31-261
West Hills, California, 91345
Krnov, 79401
Corona, California, 92879
Arlington Heights, Illinois, 60005
Federal Way, Washington, 98003
St-Petersburg, 195257
Budapest, 1138
Louisville, Kentucky, 40213
Richmond, Virginia, 23227
México, 06700
Bucuresti, 020475
Kaunas, 49449
Tucson, Arizona, 85723
Barcelona, 08035
Pápa, 8500
Palm Springs, California, 92262
Voronezh, 394018
St-Petersburg, 194354
Syracuse, New York, 13214-2016
Plock, 09-400
København Nv, 2400
Rapid City, South Dakota, 57701
Praha 4, 14900
Tacoma, Washington, 98415-0299
Hickory, North Carolina, 28601
Budapest, 1212
Aarhus C, 8000
Ocoee, Florida, 34761
Vinnytsya, 21001
Cheb, 35002
El Ferrol, 15405
Lubochna, 3491
Salisbury, North Carolina, 28144
Budapest, 1134
Puebla, 72190
Bucuresti, 020042
Evansville, Indiana, 47714
Lewiston, Maine, 04240
Samara, 443041
Krakow, 31-548
Lviv, 79010
Birmingham, Alabama, 35205
Butte, Montana, 59701
Alzira, 46600
Iasi, 700547
Temuco, 4780000
Aurora, Colorado, 80045
Vancouver, V5Y 3W2
Box Hill, 3128
Denver, Colorado, 80246
Chicago, Illinois, 60616
Lawrenceville, Georgia, 30046
Milwaukee, Wisconsin, 53209-0996
Toronto, M9V 4B4
Greenville, North Carolina, 27858
Atlanta, Georgia, 30322
Olomouc, 77900
Vinnytsya, 21010
Tartu, 50406
Houston, Texas, 77030
Kyiv
Kelowna, V1Y 1Z9
Guadalajara, 44600
Santiago, 8053095
Charleston, South Carolina, 29407
Vina Del Mar
N Richland Hill, Texas, 76180
Saratov, 410030
Chula Vista, California, 91911
Corpus Christi, Texas, 78404
Flint, Michigan, 48504
Liberec, 460 01
Kyiv, 04050
Saratov, 410053
Moldava Nad Bodvou, 04525
Santiago, 7500347
Omaha, Nebraska, 68131
Viborg, 8800
Santiago, 7500710
Malmö, 211 52
Santiago, 7500739
Hurst, Texas, 76054
Hranice, 75301
Guadalajara, 44130
Spokane, Washington, 99220
Salem, Virginia, 24153
Dayton, Ohio, 45439
Montreal, H1W 2R7
La Coruña, 15006
Baltimore, Maryland, 21237
Henderson, Nevada, 89074
Jamaica, New York, 11432
Roswell, Georgia, 30076
Nove Mesto Nad Vahom, 91501
Vilnius, LT-10323
Szczecin, 70-506
Los Angeles, California, 90057
Evansville, Indiana, 47714
Tallinn, 10138
Kyiv, 03049
Warszawa, 01-518
Little Rock, Arkansas, 72205
Los Angeles, California, 90017
Praha 8, 18100
Ogden, Utah, 84405
Stockholm, 11526
New Port Richey, Florida, 34652
Rockville, Maryland, 20852
Chino, California, 91710
Oakville, L6H 3P1
Dallas, Texas, 75216
Winston-Salem, North Carolina, 27103
Sun City, Arizona, 85351
Hunedoara, 331057
Evansville, Indiana, 47713
Wilmington, North Carolina, 28401
Wilmington, Delaware, 19713
Toronto, M9W 4L9
Moscow, 119435
Cuernavaca, 62250
Ljungby, 341 82
Stenungssund, 44431
Greenbrae, California, 94904
Indianapolis, Indiana, 46202
Indianapolis, Indiana, 46260
Rättvik, 79530
Norfolk, Virginia, 23510
Columbus, Ohio, 43213
Pärnu, 80018
Barcelona, 08036
Little Rock, Arkansas, 72205
Klaipeda, LT-92253
Austin, Texas, 78731
Debrecen, 4031
Orem, Utah, 84058
Albuquerque, New Mexico, 87131
Palm Harbor, Florida, 34684
København S, 2300
Avon, Indiana, 46123
St-Petersburg, 194291
Philadelphia, Pennsylvania, 19107
Dallas, Texas, 75208
Oradea, 410169
St. Petersburg, 194358
Dallas, Texas, 75231
Port Hueneme, California, 93041
Tempe, Arizona
Bell Gardens, California, 90201
Kosice, 04001
Praha 5, 15030
Kedainiai, LT-57164
Guelph, N1H 1B1
Salt Lake City, Utah, 84102
Tipton, Pennsylvania, 16684
Celaya, 38000
Northridge, California, 91325
Pachuca, 42084
Zilina, 01001
Baltimore, Maryland, 21237
St-Petersburg, 194354
Norfolk, Virginia, 23510
Sibiu, 550371
San Ramon, California, 94583
Plzen, 301 66
Dallas, Texas, 75246
Springfield, Illinois, 62704
Chesapeake, Virginia, 23321
Morehead City, North Carolina, 28557
Lancaster, California, 93534
Dearborn, Michigan, 48124
Timisoara, 300456
Kosice, 04013
Smithfield, Pennsylvania, 15478
Guadalajara, 44210
Austin, Texas, 78731
Bratislava, 85101
Plzen, 301 66
Prostejov, 79601
Valencia, 46014
Fresno, California, 93720
Durham, North Carolina, 27710

Tracking Information

NCT #
NCT02058160
Collaborators
Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi