NCT03211858 - Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine | Biotech Hunter

Enrollment

597

Participants

Timeline

Start Date

August 2, 2017

Primary Completion Date

July 16, 2018

Study Completion Date

January 12, 2019

Conditions

Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Interventions

DRUG

Insulin aspart

SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \<10 millimoles/liter \[mmol/L\] \[\<180 milligram/deciliter {mg/dL}\]) while avoiding hypoglycemia.

DRUG

NovoLog/NovoRapid

NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \<10 mmol/L \[\<180 mg/dL\]) while avoiding hypoglycemia.

DRUG

Insulin glargine (HOE901)

Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.

Trial Locations (82)

1036

Investigational Site Number 3480011, Budapest

1042

Investigational Site Number 3480008, Budapest

1062

Investigational Site Number 3480001, Budapest

Investigational Site Number 3480005, Budapest

1139

Investigational Site Number 3480004, Budapest

2000

Investigational Site Number 3480009, Szentendre

4031

Investigational Site Number 3480007, Debrecen

4400

Investigational Site Number 3480010, Nyíregyháza

8230

Investigational Site Number 3480012, Balatonfüred

8800

Investigational Site Number 3480003, Nagykanizsa

10001

Investigational Site Number 8400028, New York

10115

Investigational Site Number 2760001, Berlin

23758

Investigational Site Number 2760005, Oldenburg in Holstein

26330

Investigational Site Number 8400039, Bridgeport

28401

Investigational Site Number 8400010, Wilmington

28500

Investigational Site Number 2460004, Pori

28557

Investigational Site Number 8400025, Morehead City

30076

Investigational Site Number 8400032, Roswell

30318

Investigational Site Number 8400007, Atlanta

31904

Investigational Site Number 8400022, Columbus

34652

Investigational Site Number 8400031, New Port Richey

34761

Investigational Site Number 8400027, Ocoee

37404

Investigational Site Number 8400033, Chattanooga

40100

Investigational Site Number 2460006, Jyväskylä

45136

Investigational Site Number 2760006, Essen

50314

Investigational Site Number 8400005, Des Moines

58104

Investigational Site Number 8400023, Fargo

60005

Investigational Site Number 8400038, Arlington Heights

60100

Investigational Site Number 2460003, Seinäjoki

68131

Investigational Site Number 8400003, Omaha

69115

Investigational Site Number 2760004, Heidelberg

70006

Investigational Site Number 8400041, Metairie

70100

Investigational Site Number 2460002, Kuopio

72211

Investigational Site Number 8400040, Little Rock

75149

Investigational Site Number 8400016, Mesquite

75230

Investigational Site Number 8400009, Dallas

Investigational Site Number 8400035, Dallas

75246

Investigational Site Number 8400021, Dallas

77043

Investigational Site Number 8400017, Houston

77079

Investigational Site Number 8400001, Houston

77089

Investigational Site Number 8400020, Houston

78731

Investigational Site Number 8400044, Austin

80045

Investigational Site Number 8400037, Aurora

80113

Investigational Site Number 8400018, Englewood

84102

Investigational Site Number 8400034, Salt Lake City

89052

Investigational Site Number 8400024, Henderson

90057

Investigational Site Number 8400043, Los Angeles

91766

Investigational Site Number 8400036, Pomona

92025

Investigational Site Number 8400002, Escondido

92037

Investigational Site Number 8400014, La Jolla

93003

Investigational Site Number 8400013, Ventura

93105

Investigational Site Number 8400011, Santa Barbara

93720

Investigational Site Number 8400030, Fresno

94520

Investigational Site Number 8400012, Concord

94904

Investigational Site Number 8400004, Greenbrae

97701

Investigational Site Number 8400029, Bend

98057

Investigational Site Number 8400008, Renton

194358

Investigational Site Number 6430001, Saint Petersburg

410030

Investigational Site Number 6430003, Saratov

443041

Investigational Site Number 6430002, Samara

634050

Investigational Site Number 6430004, Tomsk

20852-4267

Investigational Site Number 8400015, Rockville

02453

Investigational Site Number 8400042, Waltham

48532-3447

Investigational Site Number 8400019, Flint

01796

Investigational Site Number 2760002, Pirna

Unknown

Investigational Site Number 3920009, Fukuyama-Shi

Investigational Site Number 3920008, Higashiosaka-Shi

Investigational Site Number 3920007, Kashiwara-Shi

Investigational Site Number 3920001, Koriyama-Shi

Investigational Site Number 3920005, Kumamoto

Investigational Site Number 3920003, Mito

Investigational Site Number 3920010, Osaka

Investigational Site Number 3920002, Sagamihara-Shi

Investigational Site Number 3920004, Shinjuku-Ku

Investigational Site Number 3920006, Ushiku-Shi

15-435

Investigational Site Number 6160004, Bialystok

31-501

Investigational Site Number 6160003, Krakow

31-548

Investigational Site Number 6160005, Krakow

20-538

Investigational Site Number 6160007, Lublin

33-300

Investigational Site Number 6160006, Nowy Sącz

60-834

Investigational Site Number 6160001, Poznan

02-507

Investigational Site Number 6160002, Warsaw