Recruitment

Recruitment Status
Completed
Estimated Enrollment
1047

Inclusion Criteria

Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Male or female, 18 years or older at the time of signing informed consent
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Male or female, 18 years or older at the time of signing informed consent

Exclusion Criteria

Acute coronary or cerebrovascular event within 90 days before randomisation
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
...
Acute coronary or cerebrovascular event within 90 days before randomisation
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
History of chronic or idiopathic acute pancreatitis
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Screening calcitonin value greater than or equal to 50 ng/L
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Heart failure, New York Heart Association Class IV

Summary

Conditions
  • Diabetes
  • Diabetes Mellitus - Type 2
  • Diabetes Mellitus, Type 2
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

Inclusion Criteria

Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Male or female, 18 years or older at the time of signing informed consent
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Male or female, 18 years or older at the time of signing informed consent

Exclusion Criteria

Acute coronary or cerebrovascular event within 90 days before randomisation
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
...
Acute coronary or cerebrovascular event within 90 days before randomisation
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
History of chronic or idiopathic acute pancreatitis
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Screening calcitonin value greater than or equal to 50 ng/L
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Heart failure, New York Heart Association Class IV

Locations

Arlington, Virginia, 22206
Chennai, Tamil Nadu, 600031
Carmichael, California, 95608
Plymouth, PL6 8BQ
Saint Ingbert-Oberwürzbach, 66386
...
Arlington, Virginia, 22206
Chennai, Tamil Nadu, 600031
Carmichael, California, 95608
Plymouth, PL6 8BQ
Saint Ingbert-Oberwürzbach, 66386
Berlin, New Jersey, 08009
Birmingham, Alabama, 35216
Mumbai, Maharashtra, 400010
Durban, KwaZulu-Natal, 4001
Beaver, Pennsylvania, 15009
Norcross, Georgia, 30092
Salt Lake City, Utah, 84107
Bristol, BS10 5NB
Mumbai, Maharashtra, 400008
Tetovo, 1220
Paducah, Kentucky, 42003
Sherman Oaks, California, 91403
Sterling Heights, Michigan, 48310-3503
Fargo, North Dakota, 58104
Amarillo, Texas, 79106
Toms River, New Jersey, 08755-8050
Piestany, 92101
Flint, Michigan, 48504
Saint Louis, Missouri, 63141
Cleveland, Ohio, 44122
México D.F., México, D.F., 11550
Murrells Inlet, South Carolina, 29576
Guadalajara, Jalisco, 44150
Koper, SI-6000
Miami, Florida, 33156
Krapinske Toplice, 49217
Houston, Texas, 77074
Houston, Texas, 77055
Altoona, Pennsylvania, 16602
Clearwater, Florida, 33761
West Seneca, New York, 14224
Buckley, Michigan, 49620
Mumbai, Maharashtra, 400012
Gilbert, Arizona, 85295
Münster, 48145
Soham, CB7 5JD
Las Vegas, Nevada, 89109
Novo mesto, 8000
Swansea, SA2 8PP
Paris, 75014
Mumbai, Maharashtra, 400022
Roswell, Georgia, 30076
Natchitoches, Louisiana, 71457-5881
Greensboro, North Carolina, 27408
Morganton, North Carolina, 28655
Council Bluffs, Iowa, 51501
Trenton, New Jersey, 08611
Rang-du-fliers, 62180
Walnut Creek, California, 94598
Winchester, Virginia, 22601
San Mateo, California, 94401
Fort Worth, Texas, 76117
Park City, Kansas, 67219
Rostock, 18057
Trinité - La Martinique, 97235
Spring Hill, Florida, 34609
Haxey, DN9 2HY
Knoxville, Tennessee, 37912
Chattanooga, Tennessee, 37404
Rolling Hills Estates, California, 90274
Capital Federal, C1056ABJ
Wangen, 88239
Mysore, Karnataka, 570001
Sidcup, DA14 6LT
Wenatchee, Washington, 98801-2028
Tuscumbia, Alabama, 35674
Oradea, Bihor, 410469
Berlin, 10409
Inglewood, California, 90301
Pomona, California, 91767-3008
Saint Louis, Missouri, 63128
Cakovec, 40000
Ludwigshafen, 67059
Puchov, 02001
Las Vegas, Nevada, 89119
Skopje, 1000
Peoria, Illinois, 61602
Buenos Aires, C1425AGC
Denver, Colorado, 80239-3133
Kolkata, 700026
Strasbourg, 67098
Denver, Colorado, 80220
Godoy Cruz, M5501ARP
Carlisle, Ohio, 45005
MARSEILLE cedex 08, 13285
Meridian, Idaho, 83646
LA ROCHE-sur-YON cedex 9, 85295
Lake Charles, Louisiana, 70601
Cape Town, Western Cape, 7450
Spring Valley, California, 91978
Phoenix, Arizona, 85018
Long Beach, California, 90807
Winter Park, Florida, 32789
Anaheim, California, 92801
Metairie, Louisiana, 70002
Houston, Texas, 77040
Pitesti, Arges, 110084
Jerichow, 39319
Plano, Texas, 75075
Salford, M6 8HD
Ozark, Alabama, 36360
Hyattsville, Maryland, 20782
Colorado Springs, Colorado, 80909
Lansdale, Pennsylvania, 19446-1002
Jacksonville, Florida, 32256
Aguascalientes, 20230
Ponce, 00717
Olympia, Washington, 98502
San Diego, California, 92111
Karlovac, 47000
Jacksonville, Florida, 32205
Nanterre, 92014
Madisonville, Kentucky, 42431
Los Angeles, California, 90057
Indianapolis, Indiana, 46254
Hoofddorp, 2134 TM
Chicago, Illinois, 60611
Pierre-Bénite, 69495
Pointe À Pitre, 97159
Bucharest, 011234
Cooper City, Florida, 33024
San Antonio, Texas, 78229
Ljubljana, 1525
Shreveport, Louisiana, 71107
Miami Lakes, Florida, 33016
Lampertheim, 68623
Bangalore, Karnataka, 560092
Narbonne, 11108
Troy, Michigan, 48098
Mason, Ohio, 45040-6815
NICE cedex 3, 06202
Saint Nazaire, 44600
Tustin, California, 92780
Rehlingen-Siersburg, 66780
Clairton, Pennsylvania, 15025-3730
Conyers, Georgia, 30013
Le Creusot, 71200
Morehead City, North Carolina, 28557
Wilmington, North Carolina, 28401
Bourgoin-jallieu, 38302
Zagreb, 10 000
Cincinnati, Ohio, 45255
Rapid City, South Dakota, 57701
Humble, Texas, 77338
Venissieux, 69200
Statesville, North Carolina, 28625
New Delhi, 110001
Taunton, TA1 5DA
Mysore, Karnataka, 570004
Roseville, California, 95661
Gurnee, Illinois, 60031
Northwood, HA6 2RN
Essen, 45276
Butte, Montana, 59701
Cluj Napoca, Cluj, 400006
Shelby, North Carolina, 28150
Gaffney, South Carolina, 29341
Johannesburg, Gauteng, 1829
Rialto, California, 92376
Kenosha, Wisconsin, 53144
MARSEILLE Cédex 05, 13385
Hull, HU3 2RW
Phoenix, Arizona, 85032
Caba, C1119ACN
Lakeland, Florida, 33805
San Antonio, Texas, 78209
Basingstoke, RG24 9GT
Saint George, Utah, 84790
Canal Fulton, Ohio, 44614
La Mesa, California, 91942
Toledo, Ohio, 43623
Kettering, Ohio, 45429
Iasi, 700469
Amsterdam, 1105 AZ
Marshall, Texas, 75670
Irving, Texas, 75061-2210
Orange, California, 92868-2863
Ahmedabad, Gujarat, 380007
Winter Haven, Florida, 33880
Trencin, 91101
Avon, Indiana, 46123
Albuquerque, New Mexico, 87108
Houston, Texas, 77058
Neuwied, 56564
Jacksonville, Florida, 32216
Philadelphia, Pennsylvania, 19114
Harrogate, North Yorkshire, HG2 7SX
Houston, Texas, 77070
Ipswich, IP4 5PD
Marietta, Georgia, 30060
Moldava nad Bodvou, 045 01
Cincinnati, Ohio, 45219
Kissimmee, Florida, 34741
Jersey Shore, Pennsylvania, 17740
Hurst, Texas, 76054
Johns Creek, Georgia, 30097
Johannesburg, Gauteng, 2001
Las Vegas, Nevada, 89120
Renton, Washington, 98057
Dallas, Texas, 75251
New Dehli, New Delhi, 110029
Ahmedabad, Gujarat, 380006
Longview, Texas, 75605
Corvallis, Oregon, 97330-3737
Miami, Florida, 33135
Saint Herblain, 44800
Distrito Federal, México, D.F., 14080
Kolkata, West Bengal, 700107
Lexington, Kentucky, 40503
Austin, Texas, 78756
Hialeah, Florida, 33012
Cincinnati, Ohio, 45227
Pretoria, Gauteng, 0183
Bobigny, 93009
Chula Vista, California, 91911
New Windsor, New York, 12553
Indore, Madhya Pradesh, 452010
Kosice, 04011
Bois-Guillaume, 76320
Maumee, Ohio, 43537
Elk Grove, California, 95758
Rotterdam, 3039 BD
Cincinnati, Ohio, 45242
Oceanside, California, 92056
Stuttgart, 70378
Brooklyn, New York, 11229

Tracking Information

NCT #
NCT02128932
Collaborators
Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S