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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Faster-acting insulin aspart
insulin detemir
insulin aspart
Faster-acting insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Meal time FIAsp and insulin detemir

Meal time insulin aspart and insulin detemir

Post meal FIAsp and insulin detemir

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of randomised treatment.

Secondary Outcome Measures

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).
Change From Baseline in HbA1c (Post Meal Arm)
Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.
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.
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of randomised treatment.
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.
Change in HbA1c
Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.
Change in PPG (Postprandial Glucose)
Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.

Full Information

First Posted
April 11, 2013
Last Updated
May 28, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01831765
Brief Title
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Acronym
onset® 1
Official Title
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2013 (Actual)
Primary Completion Date
May 12, 2015 (Actual)
Study Completion Date
June 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal time FIAsp and insulin detemir
Arm Type
Experimental
Arm Title
Meal time insulin aspart and insulin detemir
Arm Type
Active Comparator
Arm Title
Post meal FIAsp and insulin detemir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Intervention Description
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Description
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
Description
Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).
Time Frame
Week 0, week 26
Title
Change From Baseline in HbA1c (Post Meal Arm)
Description
Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.
Time Frame
Week 0, week 26
Title
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Description
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.
Time Frame
From baseline until week 26
Title
Change From Baseline in Body Weight
Description
Change from baseline in body weight after 26 weeks of randomised treatment.
Time Frame
Week 0, week 26
Title
Frequency of Adverse Events
Description
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.
Time Frame
After 52 weeks of randomised treatment
Title
Change in HbA1c
Description
Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.
Time Frame
Week 0, week 52
Title
Change in PPG (Postprandial Glucose)
Description
Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.
Time Frame
Week 0, week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105-4321
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003-2824
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686-6011
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052-2649
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07306
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109-2134
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301-3901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046-3638
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-5103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4254
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1334
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-3649
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3N4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 5K2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Prague 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kerava
ZIP/Postal Code
FI-04200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Raisio
ZIP/Postal Code
21200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Damme
ZIP/Postal Code
49401
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01219
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48143
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehburg-Loccum
ZIP/Postal Code
31547
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saint Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Zwenkau
ZIP/Postal Code
04442
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-261
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Szczecin
ZIP/Postal Code
70-376
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Inverness
ZIP/Postal Code
IV2 3JH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30949906
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.
Results Reference
background
PubMed Identifier
28356319
Citation
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.
Results Reference
result
PubMed Identifier
29316130
Citation
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.
Results Reference
result
PubMed Identifier
29463670
Citation
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.
Results Reference
result
PubMed Identifier
30402720
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 Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Results Reference
result
PubMed Identifier
30547388
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 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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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