Diabetes Clinical Trial
— onset® 1Official title:
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
| Verified date | May 2019 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1290 |
| Est. completion date | June 11, 2015 |
| Est. primary completion date | May 12, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novo Nordisk Investigational Site | Bonheiden | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Edegem | |
| Belgium | Novo Nordisk Investigational Site | Gent | |
| Belgium | Novo Nordisk Investigational Site | Leuven | |
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Hamilton | Ontario |
| Canada | Novo Nordisk Investigational Site | London | Ontario |
| Canada | Novo Nordisk Investigational Site | London | Ontario |
| Canada | Novo Nordisk Investigational Site | Mississauga | Ontario |
| Canada | Novo Nordisk Investigational Site | Montreal | Quebec |
| Canada | Novo Nordisk Investigational Site | Quebec | |
| Canada | Novo Nordisk Investigational Site | Sherbrooke | Quebec |
| Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
| Canada | Novo Nordisk Investigational Site | Victoria | British Columbia |
| Canada | Novo Nordisk Investigational Site | Winnipeg | Manitoba |
| Czechia | Novo Nordisk Investigational Site | Brno | |
| Czechia | Novo Nordisk Investigational Site | Hradec Kralove | |
| Czechia | Novo Nordisk Investigational Site | Prague 4 | |
| Czechia | Novo Nordisk Investigational Site | Praha | |
| Czechia | Novo Nordisk Investigational Site | Praha 10 | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kerava | |
| Finland | Novo Nordisk Investigational Site | Lappeenranta | |
| Finland | Novo Nordisk Investigational Site | Raisio | |
| Finland | Novo Nordisk Investigational Site | Tampere | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| Germany | Novo Nordisk Investigational Site | Bad Mergentheim | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Damme | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Elsterwerda | |
| Germany | Novo Nordisk Investigational Site | Falkensee | |
| Germany | Novo Nordisk Investigational Site | Friedrichsthal | |
| Germany | Novo Nordisk Investigational Site | Fulda | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hohenmölsen | |
| Germany | Novo Nordisk Investigational Site | Lingen | |
| Germany | Novo Nordisk Investigational Site | Ludwigshafen | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Neuwied | |
| Germany | Novo Nordisk Investigational Site | Oldenburg | |
| Germany | Novo Nordisk Investigational Site | Rehburg-Loccum | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Rostock | |
| Germany | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | |
| Germany | Novo Nordisk Investigational Site | Schweinfurt | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| Germany | Novo Nordisk Investigational Site | Zwenkau | |
| Hungary | Novo Nordisk Investigational Site | Budapest | |
| Hungary | Novo Nordisk Investigational Site | Budapest | |
| Hungary | Novo Nordisk Investigational Site | Debrecen | |
| Hungary | Novo Nordisk Investigational Site | Kaposvár | |
| Hungary | Novo Nordisk Investigational Site | Szeged | |
| Hungary | Novo Nordisk Investigational Site | Szombathely | |
| Poland | Novo Nordisk Investigational Site | Bialystok | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Gillingham | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Inverness | |
| United Kingdom | Novo Nordisk Investigational Site | Inverness | |
| United Kingdom | Novo Nordisk Investigational Site | Ipswich | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Portsmouth | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Amarillo | Texas |
| United States | Novo Nordisk Investigational Site | Anaheim | California |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Beaumont | Texas |
| United States | Novo Nordisk Investigational Site | Boca Raton | Florida |
| United States | Novo Nordisk Investigational Site | Butte | Montana |
| United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Concord | California |
| United States | Novo Nordisk Investigational Site | Coral Gables | Florida |
| United States | Novo Nordisk Investigational Site | Crystal Lake | Illinois |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Dunwoody | Georgia |
| United States | Novo Nordisk Investigational Site | Eagan | Minnesota |
| United States | Novo Nordisk Investigational Site | Escondido | California |
| United States | Novo Nordisk Investigational Site | Fleming Island | Florida |
| United States | Novo Nordisk Investigational Site | Fort Lauderdale | Florida |
| United States | Novo Nordisk Investigational Site | Fort Lauderdale | Florida |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Fullerton | California |
| United States | Novo Nordisk Investigational Site | Greenville | North Carolina |
| United States | Novo Nordisk Investigational Site | Greenville | South Carolina |
| United States | Novo Nordisk Investigational Site | Henderson | Nevada |
| United States | Novo Nordisk Investigational Site | Hoboken | New Jersey |
| United States | Novo Nordisk Investigational Site | Honolulu | Hawaii |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jenkintown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Jersey City | New Jersey |
| United States | Novo Nordisk Investigational Site | Kalamazoo | Michigan |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | La Mesa | California |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
| United States | Novo Nordisk Investigational Site | Lawrenceville | Georgia |
| United States | Novo Nordisk Investigational Site | Lenexa | Kansas |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Lubbock | Texas |
| United States | Novo Nordisk Investigational Site | Magna | Utah |
| United States | Novo Nordisk Investigational Site | Mentor | Ohio |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Minneapolis | Minnesota |
| United States | Novo Nordisk Investigational Site | Mobile | Alabama |
| United States | Novo Nordisk Investigational Site | Morehead City | North Carolina |
| United States | Novo Nordisk Investigational Site | Muncie | Indiana |
| United States | Novo Nordisk Investigational Site | Nampa | Idaho |
| United States | Novo Nordisk Investigational Site | Nashua | New Hampshire |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | Newark | Delaware |
| United States | Novo Nordisk Investigational Site | North Hollywood | California |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Portland | Maine |
| United States | Novo Nordisk Investigational Site | Poway | California |
| United States | Novo Nordisk Investigational Site | Renton | Washington |
| United States | Novo Nordisk Investigational Site | Rochester | New York |
| United States | Novo Nordisk Investigational Site | Rockville | Maryland |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Round Rock | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Sanford | Florida |
| United States | Novo Nordisk Investigational Site | Santa Barbara | California |
| United States | Novo Nordisk Investigational Site | Santa Barbara | California |
| United States | Novo Nordisk Investigational Site | Smithtown | New York |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Springfield | Missouri |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | Staten Island | New York |
| United States | Novo Nordisk Investigational Site | Staten Island | New York |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Ventura | California |
| United States | Novo Nordisk Investigational Site | Ventura | California |
| United States | Novo Nordisk Investigational Site | Walnut Creek | California |
| United States | Novo Nordisk Investigational Site | Waltham | Massachusetts |
| United States | Novo Nordisk Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Belgium, Canada, Czechia, Finland, Germany, Hungary, Poland, United Kingdom,
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. — View Citation
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 — View Citation
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 Subje — View Citation
Mathieu C, Bode BW, Franek E, Philis-Tsimikas A, Rose L, Graungaard T, Birk Østerskov 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-tar — View Citation
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. — View Citation
Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Østerskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of randomised treatment. | Week 0, week 26 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of randomised treatment. | Week 0, week 26 | |
| Secondary | 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 | |
| Secondary | Change in HbA1c | Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. | Week 0, week 52 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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