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DiabetesPhase 3CONCLUDENCT03078478

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

A Phase 3 study testing Insulin degludec and Insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 229 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
Insulin degludec and Insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,609 participants
Where
229 sitesin 12 countries
Study dates
13 Mar 2017to 4 Mar 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

229 sites in 12 countries.

229 sites in 12 countries

United States156 sites

  • Novo Nordisk Investigational Site

    Albany, New York, 12203

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87102

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87109-2134

  • Novo Nordisk Investigational Site

    Amarillo, Texas, 79106

  • Novo Nordisk Investigational Site

    Anderson, South Carolina, 29621

  • Novo Nordisk Investigational Site

    Anniston, Alabama, 36207

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76012-4637

  • Novo Nordisk Investigational Site

    Austin, Texas, 78731

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Bennington, Vermont, 05201

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35211

  • Novo Nordisk Investigational Site

    Blackfoot, Idaho, 83221

  • Novo Nordisk Investigational Site

    Bloomfield Hills, Michigan, 48302

  • Novo Nordisk Investigational Site

    Bountiful, Utah, 84010

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Brandon, Florida, 33511

  • Novo Nordisk Investigational Site

    Bristol, Tennessee, 37620-7352

  • Novo Nordisk Investigational Site

    Buena Park, California, 90620

  • Novo Nordisk Investigational Site

    Chandler, Arizona, 85224

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28210

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia, 23321

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33765

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80918

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43212

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43213

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Cooper City, Florida, 33024

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa, 51501

  • Novo Nordisk Investigational Site

    Dakota Dunes, South Dakota, 57049

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75226

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Downey, California, 90242

  • Novo Nordisk Investigational Site

    Duarte, California, 91010

  • Novo Nordisk Investigational Site

    East Brunswick, New Jersey, 08816

  • Novo Nordisk Investigational Site

    Elkhorn, Nebraska, 68022

  • Novo Nordisk Investigational Site

    Englewood, Colorado, 80113

  • Novo Nordisk Investigational Site

    Evansville, Indiana, 47713

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76132

  • Novo Nordisk Investigational Site

    Fountain Hills, Arizona, 85268

  • Novo Nordisk Investigational Site

    Fremont, Nebraska, 68025

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Gaffney, South Carolina, 29341

  • Novo Nordisk Investigational Site

    Glendale, Arizona, 85306-4652

  • Novo Nordisk Investigational Site

    Glendale, Arizona, 85306

  • Novo Nordisk Investigational Site

    Glendale, Arizona, 85308

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27408

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27858

  • Novo Nordisk Investigational Site

    Greenville, South Carolina, 29615

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Henderson, Nevada, 89052

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii, 96814

  • Novo Nordisk Investigational Site

    Houston, Texas, 77024

  • Novo Nordisk Investigational Site

    Houston, Texas, 77066

  • Novo Nordisk Investigational Site

    Humble, Texas, 77338

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32258

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32277

  • Novo Nordisk Investigational Site

    Kalispell, Montana, 59901

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin, 53144

  • Novo Nordisk Investigational Site

    Kerrville, Texas, 78028

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37909

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Lancaster, California, 93534

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89109

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89118

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89148

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey, 08648

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40502

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Lomita, California, 90717

  • Novo Nordisk Investigational Site

    Los Alamitos, California, 90720

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Marietta, Georgia, 30067

  • Novo Nordisk Investigational Site

    Maumee, Ohio, 43537

  • Novo Nordisk Investigational Site

    McMurray, Pennsylvania, 15317

  • Novo Nordisk Investigational Site

    Miami, Florida, 33175

  • Novo Nordisk Investigational Site

    Miami Springs, Florida, 33166

  • Novo Nordisk Investigational Site

    Midlothian, Virginia, 23114

  • Novo Nordisk Investigational Site

    Mishawaka, Indiana, 46544

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557-4346

  • Novo Nordisk Investigational Site

    Moreno Valley, California, 92555

  • Novo Nordisk Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • Novo Nordisk Investigational Site

    Murray, Utah, 84123

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37203

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37232

  • Novo Nordisk Investigational Site

    New Braunfels, Texas, 78130

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70119

  • Novo Nordisk Investigational Site

    New Port Richey, Florida, 34652

  • Novo Nordisk Investigational Site

    New Windsor, New York, 12553

  • Novo Nordisk Investigational Site

    New York, New York, 10016

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23510-2015

  • Novo Nordisk Investigational Site

    Norman, Oklahoma, 73069

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    Northridge, California, 91325

  • Novo Nordisk Investigational Site

    Ogden, Utah, 84405

  • Novo Nordisk Investigational Site

    Olympia, Washington, 98502

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68144

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32825

  • Novo Nordisk Investigational Site

    Ormond Beach, Florida, 32174

  • Novo Nordisk Investigational Site

    Paducah, Kentucky, 42001

  • Novo Nordisk Investigational Site

    Palm Harbor, Florida, 34684-3609

  • Novo Nordisk Investigational Site

    Palm Springs, California, 92262

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina, 29669

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33027

  • Novo Nordisk Investigational Site

    Peoria, Illinois, 61603

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85037

  • Novo Nordisk Investigational Site

    Plano, Texas, 75075

  • Novo Nordisk Investigational Site

    Pomona, California, 91766-2007

  • Novo Nordisk Investigational Site

    Port Charlotte, Florida, 33952

  • Novo Nordisk Investigational Site

    Poway, California, 92064

  • Novo Nordisk Investigational Site

    Richfield, Minnesota, 55432

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23219

  • Novo Nordisk Investigational Site

    Riverside, California, 92506

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roseville, California, 95661

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Sacramento, California, 95821

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78215

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78228-6205

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78249

  • Novo Nordisk Investigational Site

    San Mateo, California, 94401

  • Novo Nordisk Investigational Site

    San Ramon, California, 94583

  • Novo Nordisk Investigational Site

    Skokie, Illinois, 60077

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99201

  • Novo Nordisk Investigational Site

    Springfield, Illinois, 62711

  • Novo Nordisk Investigational Site

    Stanford, California, 94305

  • Novo Nordisk Investigational Site

    Statesville, North Carolina, 28625

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33606

  • Novo Nordisk Investigational Site

    Toledo, Ohio, 43614

  • Novo Nordisk Investigational Site

    Topeka, Kansas, 66606

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85741

  • Novo Nordisk Investigational Site

    Valparaiso, Indiana, 46383

  • Novo Nordisk Investigational Site

    Virginia Beach, Virginia, 23454

  • Novo Nordisk Investigational Site

    Vista, California, 92083

  • Novo Nordisk Investigational Site

    Waco, Texas, 76710

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut, 06708

  • Novo Nordisk Investigational Site

    Wauconda, Illinois, 60084

  • Novo Nordisk Investigational Site

    West Allis, Wisconsin, 53227

  • Novo Nordisk Investigational Site

    West Columbia, South Carolina, 29169

  • Novo Nordisk Investigational Site

    West Des Moines, Iowa, 50265

  • Novo Nordisk Investigational Site

    West Hills, California, 91304

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Germany12 sites

  • Novo Nordisk Investigational Site

    Bad Mergentheim, 97980

  • Novo Nordisk Investigational Site

    Berlin, 13597

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910

  • Novo Nordisk Investigational Site

    Essen, 45136

  • Novo Nordisk Investigational Site

    Essen, 45219

  • Novo Nordisk Investigational Site

    Falkensee, 14612

  • Novo Nordisk Investigational Site

    Friedrichsthal, 66299

  • Novo Nordisk Investigational Site

    Hamburg, 22041

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Lingen, 49808

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Canada9 sites

  • Novo Nordisk Investigational Site

    Brampton, Ontario, L6S 0C6

  • Novo Nordisk Investigational Site

    Calgary, Alberta, T2H 2G4

  • Novo Nordisk Investigational Site

    Etobicoke, Ontario, M9R 4E1

  • Novo Nordisk Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • Novo Nordisk Investigational Site

    Markham, Ontario, L3P 7P2

  • Novo Nordisk Investigational Site

    Mirabel, Quebec, J7J 2K8

  • Novo Nordisk Investigational Site

    Oakville, Ontario, L6M 1M1

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec, J1L 0H8

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Hungary9 sites

  • Novo Nordisk Investigational Site

    Budapest, 1089

  • Novo Nordisk Investigational Site

    Budapest, 1125

  • Novo Nordisk Investigational Site

    Budapest, 1131

  • Novo Nordisk Investigational Site

    Budapest, H-1083

  • Novo Nordisk Investigational Site

    Debrecen, 4043

  • Novo Nordisk Investigational Site

    Debrecen, H-4032

  • Novo Nordisk Investigational Site

    Kaposvár, 7400

  • Novo Nordisk Investigational Site

    Szeged, H-6725

  • Novo Nordisk Investigational Site

    Szombathely, H-9700

Other trials in Hungary

Poland9 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-445

  • Novo Nordisk Investigational Site

    Bytom, 41-902

  • Novo Nordisk Investigational Site

    Gdansk, 80-546

  • Novo Nordisk Investigational Site

    Gdansk, 80-858

  • Novo Nordisk Investigational Site

    Lublin, 20-362

  • Novo Nordisk Investigational Site

    Lublin, 20-538

  • Novo Nordisk Investigational Site

    Szczecin, 70-506

  • Novo Nordisk Investigational Site

    Warsaw, 00-465

  • Novo Nordisk Investigational Site

    Zabrze, 41-800

Other trials in Poland

Greece7 sites

  • Novo Nordisk Investigational Site

    Athens, GR-115 27

  • Novo Nordisk Investigational Site

    Athens, GR-11527

  • Novo Nordisk Investigational Site

    Larissa, GR-41110

  • Novo Nordisk Investigational Site

    Nikaia, GR-18454

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-54642

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57010

Other trials in Greece

Norway7 sites

  • Novo Nordisk Investigational Site

    Hamar, 2318

  • Novo Nordisk Investigational Site

    Hoenefoss, 3515

  • Novo Nordisk Investigational Site

    Oslo, 0176

  • Novo Nordisk Investigational Site

    Oslo, 0373

  • Novo Nordisk Investigational Site

    Oslo, 0424

  • Novo Nordisk Investigational Site

    Skedsmokorset, NO-2020

  • Novo Nordisk Investigational Site

    Trondheim, 7030

Other trials in Norway

Denmark6 sites

  • Novo Nordisk Investigational Site

    Aarhus N, 8200

  • Novo Nordisk Investigational Site

    Esbjerg, 6700

  • Novo Nordisk Investigational Site

    Hellerup, 2900

  • Novo Nordisk Investigational Site

    Hillerød, 3400

  • Novo Nordisk Investigational Site

    Hvidovre, 2650

  • Novo Nordisk Investigational Site

    Odense, 5000

Other trials in Denmark

Romania5 sites

  • Novo Nordisk Investigational Site

    Bucharest, 022441

  • Novo Nordisk Investigational Site

    Bucharest, 13682

  • Novo Nordisk Investigational Site

    Buzău, 120203

  • Novo Nordisk Investigational Site

    Galati, 800578

  • Novo Nordisk Investigational Site

    Oradea, Bihor County, 410469

Other trials in Romania

Estonia4 sites

  • Novo Nordisk Investigational Site

    Pärnu, 80018

  • Novo Nordisk Investigational Site

    Tallinn, 10138

  • Novo Nordisk Investigational Site

    Tallinn, 13419

  • Novo Nordisk Investigational Site

    Viljandi, 71024

Other trials in Estonia

Serbia3 sites

  • Novo Nordisk Investigational Site

    Belgrade, 11000

  • Novo Nordisk Investigational Site

    Belgrade, 11080

  • Novo Nordisk Investigational Site

    Niš, 18000

Other trials in Serbia

Puerto Rico2 sites

  • Novo Nordisk Investigational Site

    Manati, 00674

  • Novo Nordisk Investigational Site

    Ponce, 00716

Other trials in Puerto Rico

About this study

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.

Being tested
Insulin degludec, Insulin glargine
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin degludecDrug

    For subcutaneous (s.c., under the skin) injection once daily

  • Insulin glargineDrug

    For subcutaneous (s.c., under the skin) injection once daily

Study groups in NCT03078478
Study groupRoleWhat they receive
IDeg 200 U/mLExperimentalNot described
Receives: Drug: Insulin degludec
IGlar 300 U/mLActive comparatorNot described
Receives: Drug: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 Weeks

Secondary outcomes (15)

  1. 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).

    Measured: 88 weeks

  2. 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.

    Measured: 36 weeks

  3. 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.

    Measured: 36 weeks (maintenance 2)

  4. 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).

    Measured: Week 0, week 88

  5. 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).

    Measured: Week 0, week 88

  6. 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).

    Measured: At 88 weeks

  7. 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).

    Measured: At 88 weeks

  8. 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).

    Measured: End of Treatment (up to 88 Weeks)

  9. 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).

    Measured: At 88 weeks

  10. 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.

    Measured: Week 0, week 88

  11. 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.

    Measured: 88 weeks

  12. 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.

    Measured: 88 weeks

  13. 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.

    Measured: 88 weeks

  14. 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.

    Measured: 88 weeks

  15. 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).

    Measured: Week 0, week 88

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2017
  2. Study start13 Mar 2017
  3. Primary completion13 Feb 2019
  4. Study completion4 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078478
Sponsor's protocol ID
NN1250-4252
Other IDs
U1111-1184-8175, 2016-002801-20, 2016
Acronym
CONCLUDE
Status last verified
Jan 2022
First submitted
10 Mar 2017
Last updated
11 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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.

    PubMed 30974986

  • 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.

    PubMed 31984443

  • 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.

    PubMed 32306247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin degludec and Insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 229 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Germany, Canada, Hungary, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (time frame: 36 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03078478, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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