A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs (CONCLUDE)

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: Insulin degludec; Drug: Insulin glargine

• Study Type: Interventional
• Enrollment (Actual): 1609
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • Novo Nordisk Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Novo Nordisk Investigational Site
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novo Nordisk Investigational Site
    • Markham, Ontario, Canada, L3P 7P2
      • Novo Nordisk Investigational Site
    • Oakville, Ontario, Canada, L6M 1M1
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M4G 3E8
      • Novo Nordisk Investigational Site
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Novo Nordisk Investigational Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Novo Nordisk Investigational Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Novo Nordisk Investigational Site
  • Esbjerg, Denmark, 6700
    • Novo Nordisk Investigational Site
  • Hellerup, Denmark, 2900
    • Novo Nordisk Investigational Site
  • Hillerød, Denmark, 3400
    • Novo Nordisk Investigational Site
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site
  • Odense, Denmark, 5000
    • Novo Nordisk Investigational Site
• Estonia
  • Pärnu, Estonia, 80018
    • Novo Nordisk Investigational Site
  • Tallinn, Estonia, 13419
    • Novo Nordisk Investigational Site
  • Tallinn, Estonia, 10138
    • Novo Nordisk Investigational Site
  • Viljandi, Estonia, 71024
    • Novo Nordisk Investigational Site
• Germany
  • Bad Mergentheim, Germany, 97980
    • Novo Nordisk Investigational Site
  • Berlin, Germany, 13597
    • Novo Nordisk Investigational Site
  • Elsterwerda, Germany, 04910
    • Novo Nordisk Investigational Site
  • Essen, Germany, 45136
    • Novo Nordisk Investigational Site
  • Essen, Germany, 45219
    • Novo Nordisk Investigational Site
  • Falkensee, Germany, 14612
    • Novo Nordisk Investigational Site
  • Friedrichsthal, Germany, 66299
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22607
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22041
    • Novo Nordisk Investigational Site
  • Lingen, Germany, 49808
    • Novo Nordisk Investigational Site
  • Rehlingen-Siersburg, Germany, 66780
    • Novo Nordisk Investigational Site
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Novo Nordisk Investigational Site
• Greece
  • Athens, Greece, GR-11527
    • Novo Nordisk Investigational Site
  • Athens, Greece, GR-115 27
    • Novo Nordisk Investigational Site
  • Larissa, Greece, GR-41110
    • Novo Nordisk Investigational Site
  • Nikaia, Greece, GR-18454
    • Novo Nordisk Investigational Site
  • Thessaloniki, Greece, GR-57010
    • Novo Nordisk Investigational Site
  • Thessaloniki, Greece, GR-57001
    • Novo Nordisk Investigational Site
  • Thessaloniki, Greece, GR-54642
    • Novo Nordisk Investigational Site
• Hungary
  • Budapest, Hungary, 1125
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, 1089
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, 1131
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, H-1083
    • Novo Nordisk Investigational Site
  • Debrecen, Hungary, 4043
    • Novo Nordisk Investigational Site
  • Debrecen, Hungary, H-4032
    • Novo Nordisk Investigational Site
  • Kaposvár, Hungary, 7400
    • Novo Nordisk Investigational Site
  • Szeged, Hungary, H-6725
    • Novo Nordisk Investigational Site
  • Szombathely, Hungary, H-9700
    • Novo Nordisk Investigational Site
• Norway
  • Hamar, Norway, 2318
    • Novo Nordisk Investigational Site
  • Hoenefoss, Norway, 3515
    • Novo Nordisk Investigational Site
  • Oslo, Norway, 0373
    • Novo Nordisk Investigational Site
  • Oslo, Norway, 0424
    • Novo Nordisk Investigational Site
  • Oslo, Norway, 0176
    • Novo Nordisk Investigational Site
  • Skedsmokorset, Norway, NO-2020
    • Novo Nordisk Investigational Site
  • Trondheim, Norway, 7030
    • Novo Nordisk Investigational Site
• Poland
  • Bialystok, Poland, 15-445
    • Novo Nordisk Investigational Site
  • Bytom, Poland, 41-902
    • Novo Nordisk Investigational Site
  • Gdansk, Poland, 80-858
    • Novo Nordisk Investigational Site
  • Gdansk, Poland, 80-546
    • Novo Nordisk Investigational Site
  • Lublin, Poland, 20-538
    • Novo Nordisk Investigational Site
  • Lublin, Poland, 20-362
    • Novo Nordisk Investigational Site
  • Szczecin, Poland, 70-506
    • Novo Nordisk Investigational Site
  • Warsaw, Poland, 00-465
    • Novo Nordisk Investigational Site
  • Zabrze, Poland, 41-800
    • Novo Nordisk Investigational Site
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Novo Nordisk Investigational Site
  • Ponce, Puerto Rico, 00716
    • Novo Nordisk Investigational Site
• Romania
  • Bucharest, Romania, 13682
    • Novo Nordisk Investigational Site
  • Bucharest, Romania, 022441
    • Novo Nordisk Investigational Site
  • Buzau, Romania, 120203
    • Novo Nordisk Investigational Site
  • Galati, Romania, 800578
    • Novo Nordisk Investigational Site
  • Bihor
    • Oradea, Bihor, Romania, 410469
      • Novo Nordisk Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novo Nordisk Investigational Site
  • Belgrade, Serbia, 11080
    • Novo Nordisk Investigational Site
  • Nis, Serbia, 18000
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Novo Nordisk Investigational Site
    • Birmingham, Alabama, United States, 35211
      • Novo Nordisk Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Novo Nordisk Investigational Site
    • Fountain Hills, Arizona, United States, 85268
      • Novo Nordisk Investigational Site
    • Glendale, Arizona, United States, 85306
      • Novo Nordisk Investigational Site
    • Glendale, Arizona, United States, 85306-4652
      • Novo Nordisk Investigational Site
    • Glendale, Arizona, United States, 85308
      • Novo Nordisk Investigational Site
    • Phoenix, Arizona, United States, 85037
      • Novo Nordisk Investigational Site
    • Tucson, Arizona, United States, 85741
      • Novo Nordisk Investigational Site
  • California
    • Buena Park, California, United States, 90620
      • Novo Nordisk Investigational Site
    • Concord, California, United States, 94520
      • Novo Nordisk Investigational Site
    • Downey, California, United States, 90242
      • Novo Nordisk Investigational Site
    • Duarte, California, United States, 91010
      • Novo Nordisk Investigational Site
    • Fresno, California, United States, 93720
      • Novo Nordisk Investigational Site
    • La Jolla, California, United States, 92037
      • Novo Nordisk Investigational Site
    • Lancaster, California, United States, 93534
      • Novo Nordisk Investigational Site
    • Lomita, California, United States, 90717
      • Novo Nordisk Investigational Site
    • Los Alamitos, California, United States, 90720
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90057
      • Novo Nordisk Investigational Site
    • Moreno Valley, California, United States, 92555
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91325
      • Novo Nordisk Investigational Site
    • Palm Springs, California, United States, 92262
      • Novo Nordisk Investigational Site
    • Pomona, California, United States, 91766-2007
      • Novo Nordisk Investigational Site
    • Poway, California, United States, 92064
      • Novo Nordisk Investigational Site
    • Riverside, California, United States, 92506
      • Novo Nordisk Investigational Site
    • Roseville, California, United States, 95661
      • Novo Nordisk Investigational Site
    • Sacramento, California, United States, 95821
      • Novo Nordisk Investigational Site
    • San Mateo, California, United States, 94401
      • Novo Nordisk Investigational Site
    • San Ramon, California, United States, 94583
      • Novo Nordisk Investigational Site
    • Stanford, California, United States, 94305
      • Novo Nordisk Investigational Site
    • Vista, California, United States, 92083
      • Novo Nordisk Investigational Site
    • Walnut Creek, California, United States, 94598
      • Novo Nordisk Investigational Site
    • West Hills, California, United States, 91304
      • Novo Nordisk Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Novo Nordisk Investigational Site
    • Englewood, Colorado, United States, 80113
      • Novo Nordisk Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Novo Nordisk Investigational Site
  • Florida
    • Bradenton, Florida, United States, 34201
      • Novo Nordisk Investigational Site
    • Brandon, Florida, United States, 33511
      • Novo Nordisk Investigational Site
    • Clearwater, Florida, United States, 33765
      • Novo Nordisk Investigational Site
    • Cooper City, Florida, United States, 33024
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32258
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32277
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33175
      • Novo Nordisk Investigational Site
    • Miami Springs, Florida, United States, 33166
      • Novo Nordisk Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32825
      • Novo Nordisk Investigational Site
    • Ormond Beach, Florida, United States, 32174
      • Novo Nordisk Investigational Site
    • Palm Harbor, Florida, United States, 34684-3609
      • Novo Nordisk Investigational Site
    • Pembroke Pines, Florida, United States, 33027
      • Novo Nordisk Investigational Site
    • Port Charlotte, Florida, United States, 33952
      • Novo Nordisk Investigational Site
    • Tampa, Florida, United States, 33606
      • Novo Nordisk Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Novo Nordisk Investigational Site
    • Roswell, Georgia, United States, 30076
      • Novo Nordisk Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Novo Nordisk Investigational Site
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
    • Gurnee, Illinois, United States, 60031
      • Novo Nordisk Investigational Site
    • Peoria, Illinois, United States, 61603
      • Novo Nordisk Investigational Site
    • Skokie, Illinois, United States, 60077
      • Novo Nordisk Investigational Site
    • Springfield, Illinois, United States, 62711
      • Novo Nordisk Investigational Site
    • Wauconda, Illinois, United States, 60084
      • Novo Nordisk Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Novo Nordisk Investigational Site
    • Mishawaka, Indiana, United States, 46544
      • Novo Nordisk Investigational Site
    • Valparaiso, Indiana, United States, 46383
      • Novo Nordisk Investigational Site
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • Novo Nordisk Investigational Site
    • West Des Moines, Iowa, United States, 50265
      • Novo Nordisk Investigational Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novo Nordisk Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Novo Nordisk Investigational Site
    • Lexington, Kentucky, United States, 40502
      • Novo Nordisk Investigational Site
    • Louisville, Kentucky, United States, 40213
      • Novo Nordisk Investigational Site
    • Paducah, Kentucky, United States, 42001
      • Novo Nordisk Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Novo Nordisk Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Novo Nordisk Investigational Site
  • Minnesota
    • Richfield, Minnesota, United States, 55432
      • Novo Nordisk Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Novo Nordisk Investigational Site
  • Montana
    • Kalispell, Montana, United States, 59901
      • Novo Nordisk Investigational Site
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • Novo Nordisk Investigational Site
    • Fremont, Nebraska, United States, 68025
      • Novo Nordisk Investigational Site
    • Omaha, Nebraska, United States, 68144
      • Novo Nordisk Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89148
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89109
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89118
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Nashua, New Hampshire, United States, 03063
      • Novo Nordisk Investigational Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Novo Nordisk Investigational Site
    • Lawrenceville, New Jersey, United States, 08648
      • Novo Nordisk Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Novo Nordisk Investigational Site
    • Albuquerque, New Mexico, United States, 87109-2134
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12203
      • Novo Nordisk Investigational Site
    • New Windsor, New York, United States, 12553
      • Novo Nordisk Investigational Site
    • New York, New York, United States, 10016
      • Novo Nordisk Investigational Site
    • Northport, New York, United States, 11768
      • Novo Nordisk Investigational Site
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Novo Nordisk Investigational Site
    • Charlotte, North Carolina, United States, 28210
      • Novo Nordisk Investigational Site
    • Greensboro, North Carolina, United States, 27408
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27858
      • Novo Nordisk Investigational Site
    • Morehead City, North Carolina, United States, 28557-4346
      • Novo Nordisk Investigational Site
    • Statesville, North Carolina, United States, 28625
      • Novo Nordisk Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Novo Nordisk Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Novo Nordisk Investigational Site
    • Columbus, Ohio, United States, 43212
      • Novo Nordisk Investigational Site
    • Maumee, Ohio, United States, 43537
      • Novo Nordisk Investigational Site
    • Toledo, Ohio, United States, 43614
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Novo Nordisk Investigational Site
    • McMurray, Pennsylvania, United States, 15317
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19114
      • Novo Nordisk Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Novo Nordisk Investigational Site
    • Gaffney, South Carolina, United States, 29341
      • Novo Nordisk Investigational Site
    • Greenville, South Carolina, United States, 29615
      • Novo Nordisk Investigational Site
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Novo Nordisk Investigational Site
    • Pelzer, South Carolina, United States, 29669
      • Novo Nordisk Investigational Site
    • West Columbia, South Carolina, United States, 29169
      • Novo Nordisk Investigational Site
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620-7352
      • Novo Nordisk Investigational Site
    • Chattanooga, Tennessee, United States, 37404
      • Novo Nordisk Investigational Site
    • Chattanooga, Tennessee, United States, 37411
      • Novo Nordisk Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
    • Knoxville, Tennessee, United States, 37909
      • Novo Nordisk Investigational Site
    • Nashville, Tennessee, United States, 37232
      • Novo Nordisk Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Novo Nordisk Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Novo Nordisk Investigational Site
    • Arlington, Texas, United States, 76012-4637
      • Novo Nordisk Investigational Site
    • Austin, Texas, United States, 78731
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-9302
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75226
      • Novo Nordisk Investigational Site
    • Fort Worth, Texas, United States, 76132
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77024
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77066
      • Novo Nordisk Investigational Site
    • Humble, Texas, United States, 77338
      • Novo Nordisk Investigational Site
    • Kerrville, Texas, United States, 78028
      • Novo Nordisk Investigational Site
    • New Braunfels, Texas, United States, 78130
      • Novo Nordisk Investigational Site
    • Plano, Texas, United States, 75075
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78229
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78215
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78224
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78228-6205
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78249
      • Novo Nordisk Investigational Site
    • Waco, Texas, United States, 76710
      • Novo Nordisk Investigational Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • Novo Nordisk Investigational Site
    • Murray, Utah, United States, 84123
      • Novo Nordisk Investigational Site
    • Ogden, Utah, United States, 84405
      • Novo Nordisk Investigational Site
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Novo Nordisk Investigational Site
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Novo Nordisk Investigational Site
    • Midlothian, Virginia, United States, 23114
      • Novo Nordisk Investigational Site
    • Norfolk, Virginia, United States, 23510-2015
      • Novo Nordisk Investigational Site
    • Richmond, Virginia, United States, 23219
      • Novo Nordisk Investigational Site
    • Virginia Beach, Virginia, United States, 23454
      • Novo Nordisk Investigational Site
  • Washington
    • Olympia, Washington, United States, 98502
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99201
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Novo Nordisk Investigational Site
    • West Allis, Wisconsin, United States, 53227
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Subjects fulfilling at least one of the below criteria (For this inclusion criterion the aim is to include minimum 80% of individuals with a previous episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013 (An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.). - b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom unawareness (History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5 years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically) with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of screening with or without any of the following anti-diabetic drugs with stable doses for equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4 inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDeg 200 U/mL	Drug: Insulin degludec; For subcutaneous (s.c., under the skin) injection once daily
Active Comparator: IGlar 300 U/mL	Drug: Insulin glargine; For subcutaneous (s.c., under the skin) injection once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)	The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).	88 weeks
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 weeks
Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 weeks (maintenance 2)
Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)	Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88).	Week 0, week 88
Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)	Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88).	Week 0, week 88
Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)	Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks).	At 88 weeks
Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)	Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks).	At 88 weeks
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)	Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).	End of Treatment (up to 88 Weeks)
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)	Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).	At 88 weeks
Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)	Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented.	Week 0, week 88
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)	The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100.	88 weeks
Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)	Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).	Week 0, week 88

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Philis-Tsimikas A, Stratton I, Norgard Troelsen L, Anker Bak B, Leiter LA. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11.
• Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020 Apr;63(4):698-710. doi: 10.1007/s00125-019-05080-9. Epub 2020 Jan 27.
• Evans M, Moes RGJ, Pedersen KS, Gundgaard J, Pieber TR. Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial. Adv Ther. 2020 May;37(5):2413-2426. doi: 10.1007/s12325-020-01332-y. Epub 2020 Apr 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: NN1250-4252; U1111-1184-8175 (Other Identifier: WHO); 2016-002801-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No