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)

January 6, 2022 updated by: Novo Nordisk A/S
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1609

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)
Time Frame: 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)
Time Frame: 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)
Time Frame: 36 weeks (maintenance 2)
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)
Time Frame: Week 0, week 88
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)
Time Frame: Week 0, week 88
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)
Time Frame: At 88 weeks
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)
Time Frame: At 88 weeks
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)
Time Frame: End of Treatment (up to 88 Weeks)
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)
Time Frame: At 88 weeks
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)
Time Frame: Week 0, week 88
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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Week 0, week 88
Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).
Week 0, week 88

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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