Recruitment

Recruitment Status
Completed
Estimated Enrollment
700

Inclusion Criterias

metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
a glinide,
Signed written informed consent.
...
metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
a glinide,
Signed written informed consent.
Treatment with basal insulin for at least 6 months before the screening visit.
Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
a sulfonylurea,
a dipeptidyl-peptidase-4 inhibitor,
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 sodium glucose co-transporter 2 inhibitor,
Type 2 diabetes mellitus diagnosed at least 1 year 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 Criterias

Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
Amylase and/or lipase more than 3 ULN .
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).
Amylase and/or lipase more than 3 ULN .
HbA1c less than 7% or above 10% .
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).

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 Criterias

metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
a glinide,
Signed written informed consent.
...
metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
a glinide,
Signed written informed consent.
Treatment with basal insulin for at least 6 months before the screening visit.
Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
a sulfonylurea,
a dipeptidyl-peptidase-4 inhibitor,
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 sodium glucose co-transporter 2 inhibitor,
Type 2 diabetes mellitus diagnosed at least 1 year 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 Criterias

Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
Amylase and/or lipase more than 3 ULN .
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).
Amylase and/or lipase more than 3 ULN .
HbA1c less than 7% or above 10% .
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).

Locations

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

Tracking Information

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