Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes (onset® 1)

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Faster-acting insulin aspart; Drug: insulin detemir; Drug: Faster-acting insulin aspart; Drug: insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 1290
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Novo Nordisk Investigational Site
  • Brussels, Belgium, 1070
    • Novo Nordisk Investigational Site
  • Edegem, Belgium, 2650
    • Novo Nordisk Investigational Site
  • Gent, Belgium, 9000
    • Novo Nordisk Investigational Site
  • Leuven, Belgium, 3000
    • Novo Nordisk Investigational Site
• Canada
  • Quebec, Canada, G1V 4G2
    • Novo Nordisk Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • Novo Nordisk Investigational Site
    • Edmonton, Alberta, Canada, T5J 3N4
      • Novo Nordisk Investigational Site
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 1J8
      • Novo Nordisk Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Novo Nordisk Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novo Nordisk Investigational Site
    • London, Ontario, Canada, N6G 2M1
      • Novo Nordisk Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • Novo Nordisk Investigational Site
    • Mississauga, Ontario, Canada, L5M 2V8
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M5T 3L9
      • Novo Nordisk Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Novo Nordisk Investigational Site
    • Sherbrooke, Quebec, Canada, J1G 5K2
      • Novo Nordisk Investigational Site
• Czechia
  • Brno, Czechia, 65691
    • Novo Nordisk Investigational Site
  • Hradec Kralove, Czechia, 50005
    • Novo Nordisk Investigational Site
  • Prague 4, Czechia, 140 21
    • Novo Nordisk Investigational Site
  • Praha, Czechia, 12808
    • Novo Nordisk Investigational Site
  • Praha 10, Czechia, 100 00
    • Novo Nordisk Investigational Site
• Finland
  • Helsinki, Finland, 00260
    • Novo Nordisk Investigational Site
  • Kerava, Finland, FI-04200
    • Novo Nordisk Investigational Site
  • Lappeenranta, Finland, 53130
    • Novo Nordisk Investigational Site
  • Raisio, Finland, 21200
    • Novo Nordisk Investigational Site
  • Tampere, Finland, 33900
    • Novo Nordisk Investigational Site
  • Turku, Finland, FI-20100
    • Novo Nordisk Investigational Site
• Germany
  • Bad Mergentheim, Germany, 97980
    • Novo Nordisk Investigational Site
  • Berlin, Germany, 13597
    • Novo Nordisk Investigational Site
  • Damme, Germany, 49401
    • Novo Nordisk Investigational Site
  • Dresden, Germany, 01219
    • Novo Nordisk Investigational Site
  • Dresden, Germany, 01307
    • Novo Nordisk Investigational Site
  • Elsterwerda, Germany, 04910
    • Novo Nordisk Investigational Site
  • Falkensee, Germany, 14612
    • Novo Nordisk Investigational Site
  • Friedrichsthal, Germany, 66299
    • Novo Nordisk Investigational Site
  • Fulda, Germany, 36037
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22607
    • Novo Nordisk Investigational Site
  • Hohenmölsen, Germany, 06679
    • Novo Nordisk Investigational Site
  • Lingen, Germany, 49808
    • Novo Nordisk Investigational Site
  • Ludwigshafen, Germany, 67059
    • Novo Nordisk Investigational Site
  • Münster, Germany, 48145
    • Novo Nordisk Investigational Site
  • Münster, Germany, 48143
    • Novo Nordisk Investigational Site
  • Neuwied, Germany, 56564
    • Novo Nordisk Investigational Site
  • Oldenburg, Germany, 23758
    • Novo Nordisk Investigational Site
  • Rehburg-Loccum, Germany, 31547
    • Novo Nordisk Investigational Site
  • Rehlingen-Siersburg, Germany, 66780
    • Novo Nordisk Investigational Site
  • Rostock, Germany, 18057
    • Novo Nordisk Investigational Site
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Novo Nordisk Investigational Site
  • Schweinfurt, Germany, 97421
    • Novo Nordisk Investigational Site
  • Völklingen, Germany, 66333
    • Novo Nordisk Investigational Site
  • Wangen, Germany, 88239
    • Novo Nordisk Investigational Site
  • Zwenkau, Germany, 04442
    • Novo Nordisk Investigational Site
• Hungary
  • Budapest, Hungary, 1089
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, 1076
    • Novo Nordisk Investigational Site
  • Debrecen, Hungary, 4043
    • Novo Nordisk Investigational Site
  • Kaposvár, Hungary, 7400
    • Novo Nordisk Investigational Site
  • Szeged, Hungary, H-6720
    • Novo Nordisk Investigational Site
  • Szombathely, Hungary, H-9700
    • Novo Nordisk Investigational Site
• Poland
  • Bialystok, Poland, 15-435
    • Novo Nordisk Investigational Site
  • Gdansk, Poland, 80-858
    • Novo Nordisk Investigational Site
  • Krakow, Poland, 31-261
    • Novo Nordisk Investigational Site
  • Lublin, Poland, 20-538
    • Novo Nordisk Investigational Site
  • Szczecin, Poland, 70-376
    • Novo Nordisk Investigational Site
  • Warszawa, Poland, 02-507
    • Novo Nordisk Investigational Site
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Novo Nordisk Investigational Site
  • Gillingham, United Kingdom, ME7 5NY
    • Novo Nordisk Investigational Site
  • Glasgow, United Kingdom, G21 3UW
    • Novo Nordisk Investigational Site
  • Guildford, United Kingdom, GU2 7XX
    • Novo Nordisk Investigational Site
  • Inverness, United Kingdom, IV2 3UJ
    • Novo Nordisk Investigational Site
  • Inverness, United Kingdom, IV2 3JH
    • Novo Nordisk Investigational Site
  • Ipswich, United Kingdom, IP4 5PD
    • Novo Nordisk Investigational Site
  • Nottingham, United Kingdom, NG7 2UH
    • Novo Nordisk Investigational Site
  • Portsmouth, United Kingdom, PO6 3LY
    • Novo Nordisk Investigational Site
  • Sheffield, United Kingdom, S5 7AU
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Novo Nordisk Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85714
      • Novo Nordisk Investigational Site
    • Tucson, Arizona, United States, 85724
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Concord, California, United States, 94520
      • Novo Nordisk Investigational Site
    • Escondido, California, United States, 92025
      • Novo Nordisk Investigational Site
    • Fresno, California, United States, 93720
      • Novo Nordisk Investigational Site
    • Fullerton, California, United States, 92835
      • Novo Nordisk Investigational Site
    • Inglewood, California, United States, 90301
      • Novo Nordisk Investigational Site
    • La Jolla, California, United States, 92037
      • Novo Nordisk Investigational Site
    • La Mesa, California, United States, 91942
      • Novo Nordisk Investigational Site
    • Long Beach, California, United States, 90807
      • Novo Nordisk Investigational Site
    • North Hollywood, California, United States, 91606
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91324
      • Novo Nordisk Investigational Site
    • Poway, California, United States, 92064
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92037
      • Novo Nordisk Investigational Site
    • Santa Barbara, California, United States, 93105
      • Novo Nordisk Investigational Site
    • Santa Barbara, California, United States, 93105-4321
      • Novo Nordisk Investigational Site
    • Ventura, California, United States, 93003
      • Novo Nordisk Investigational Site
    • Ventura, California, United States, 93003-2824
      • Novo Nordisk Investigational Site
    • Walnut Creek, California, United States, 94598
      • Novo Nordisk Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80209
      • Novo Nordisk Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Novo Nordisk Investigational Site
  • Florida
    • Boca Raton, Florida, United States, 33433
      • Novo Nordisk Investigational Site
    • Coral Gables, Florida, United States, 33134
      • Novo Nordisk Investigational Site
    • Fleming Island, Florida, United States, 32203
      • Novo Nordisk Investigational Site
    • Fort Lauderdale, Florida, United States, 33312
      • Novo Nordisk Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32204
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33156
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33174
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33136
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33173
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33015
      • Novo Nordisk Investigational Site
    • Sanford, Florida, United States, 32771
      • Novo Nordisk Investigational Site
    • Tampa, Florida, United States, 33614
      • Novo Nordisk Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Novo Nordisk Investigational Site
    • Atlanta, Georgia, United States, 30339
      • Novo Nordisk Investigational Site
    • Dunwoody, Georgia, United States, 30338
      • Novo Nordisk Investigational Site
    • Lawrenceville, Georgia, United States, 30046
      • Novo Nordisk Investigational Site
    • Roswell, Georgia, United States, 30076
      • Novo Nordisk Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Novo Nordisk Investigational Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404-7596
      • Novo Nordisk Investigational Site
    • Nampa, Idaho, United States, 83686-6011
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
    • Chicago, Illinois, United States, 60064
      • Novo Nordisk Investigational Site
    • Crystal Lake, Illinois, United States, 60012
      • Novo Nordisk Investigational Site
    • Springfield, Illinois, United States, 62711
      • Novo Nordisk Investigational Site
  • Indiana
    • Muncie, Indiana, United States, 47304
      • Novo Nordisk Investigational Site
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Novo Nordisk Investigational Site
    • 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
  • Maine
    • Portland, Maine, United States, 04101
      • Novo Nordisk Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Novo Nordisk Investigational Site
    • Baltimore, Maryland, United States, 21204
      • Novo Nordisk Investigational Site
    • Hyattsville, Maryland, United States, 20782
      • Novo Nordisk Investigational Site
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Novo Nordisk Investigational Site
    • Worcester, Massachusetts, United States, 01655
      • Novo Nordisk Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Novo Nordisk Investigational Site
  • Minnesota
    • Eagan, Minnesota, United States, 55123
      • Novo Nordisk Investigational Site
    • Minneapolis, Minnesota, United States, 55416
      • Novo Nordisk Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64106
      • Novo Nordisk Investigational Site
    • Springfield, Missouri, United States, 65807
      • Novo Nordisk Investigational Site
  • Montana
    • Butte, Montana, United States, 59701
      • Novo Nordisk Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Novo Nordisk Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052-2649
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89148
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89128
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Nashua, New Hampshire, United States, 03063
      • Novo Nordisk Investigational Site
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Novo Nordisk Investigational Site
    • Jersey City, New Jersey, United States, 07306
      • Novo Nordisk Investigational Site
    • Lawrenceville, New Jersey, United States, 08648
      • Novo Nordisk Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Novo Nordisk Investigational Site
    • Albuquerque, New Mexico, United States, 87109-2134
      • Novo Nordisk Investigational Site
    • Albuquerque, New Mexico, United States, 87131
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Novo Nordisk Investigational Site
    • New York, New York, United States, 10029
      • Novo Nordisk Investigational Site
    • Rochester, New York, United States, 14607
      • Novo Nordisk Investigational Site
    • Smithtown, New York, United States, 11787
      • Novo Nordisk Investigational Site
    • Staten Island, New York, United States, 10301
      • Novo Nordisk Investigational Site
    • Staten Island, New York, United States, 10301-3901
      • Novo Nordisk Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
    • Morehead City, North Carolina, United States, 28557
      • Novo Nordisk Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Novo Nordisk Investigational Site
    • Mentor, Ohio, United States, 44060
      • Novo Nordisk Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novo Nordisk Investigational Site
    • Portland, Oregon, United States, 97210
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046-3638
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140-5103
      • Novo Nordisk Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605-4254
      • Novo Nordisk Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Novo Nordisk Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Novo Nordisk Investigational Site
    • Austin, Texas, United States, 78731
      • Novo Nordisk Investigational Site
    • Beaumont, Texas, United States, 77701
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-9302
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75231
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77079
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77099
      • Novo Nordisk Investigational Site
    • Lubbock, Texas, United States, 79423
      • Novo Nordisk Investigational Site
    • Plano, Texas, United States, 75093
      • Novo Nordisk Investigational Site
    • Round Rock, Texas, United States, 78681
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Novo Nordisk Investigational Site
  • Utah
    • Magna, Utah, United States, 84044
      • Novo Nordisk Investigational Site
  • Washington
    • Olympia, Washington, United States, 98502
      • Novo Nordisk Investigational Site
    • Renton, Washington, United States, 98057
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99208
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99201
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99202
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99202-1334
      • Novo Nordisk Investigational Site
    • Spokane, Washington, United States, 99202-3649
      • 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: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Meal time FIAsp and insulin detemir	Drug: Faster-acting insulin aspart; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.; Drug: insulin detemir; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.; Drug: Faster-acting insulin aspart; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
ACTIVE_COMPARATOR: Meal time insulin aspart and insulin detemir	Drug: insulin detemir; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.; Drug: insulin aspart; Injected subcutaneously (s.c., under the skin), dose individually adjusted.
EXPERIMENTAL: Post meal FIAsp and insulin detemir	Drug: Faster-acting insulin aspart; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.; Drug: insulin detemir; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.; Drug: Faster-acting insulin aspart; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Change from baseline in HbA1c after 26 weeks of randomised treatment.	Week 0, week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)	Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).	Week 0, week 26
Change From Baseline in HbA1c (Post Meal Arm)	Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.	Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes	Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.	From baseline until week 26
Change From Baseline in Body Weight	Change from baseline in body weight after 26 weeks of randomised treatment.	Week 0, week 26
Frequency of Adverse Events	All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.	After 52 weeks of randomised treatment
Change in HbA1c	Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.	Week 0, week 52
Change in PPG (Postprandial Glucose)	Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.	Week 0, week 52

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. No abstract available.
• Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
• Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.
• Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Osterskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.
• Mathieu C, Bode BW, Franek E, Philis-Tsimikas A, Rose L, Graungaard T, Birk Osterskov A, Russell-Jones D. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018 May;20(5):1148-1155. doi: 10.1111/dom.13205. Epub 2018 Feb 4.
• Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2013
• Primary Completion (ACTUAL): May 12, 2015
• Study Completion (ACTUAL): June 11, 2015

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (ESTIMATE): April 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
• Other Study ID Numbers: NN1218-3852; 2010-024049-53 (EUDRACT_NUMBER); U1111-1118-2442 (OTHER: WHO)