Recruitment

Recruitment Status
Completed
Estimated Enrollment
1047

Inclusion Criterias

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
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
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
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criterias

Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
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
...
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
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
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
Screening calcitonin value greater than or equal to 50 ng/L
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Acute coronary or cerebrovascular event within 90 days before randomisation
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
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)
Heart failure, New York Heart Association Class IV

Summary

Conditions
  • Diabetes
  • 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 Criterias

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
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
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
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criterias

Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
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
...
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
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
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
Screening calcitonin value greater than or equal to 50 ng/L
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Acute coronary or cerebrovascular event within 90 days before randomisation
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
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)
Heart failure, New York Heart Association Class IV

Locations

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

Tracking Information

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