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A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 5)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin icodec
Insulin Glargine 100U/mL
Insulin Degludec
Insulin Glargine 300U/mL
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
  • HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
  • Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists
  • Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
  • Any disorder which in the investigator's opinion might jeopardise subject's safety

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin icodec with DoseGuide

Once daily basal insulin analogues

Arm Description

Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.

Participants randomised to basal insulin analogue injections once daily

Outcomes

Primary Outcome Measures

Change in HbA1c (glycated haemoglobin)
%-point

Secondary Outcome Measures

Time from baseline to treatment discontinuation or intensification
Days
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction
Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain
Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Number of episodes

Full Information

First Posted
February 17, 2021
Last Updated
August 10, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04760626
Brief Title
A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
Acronym
ONWARDS 5
Official Title
Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares insulin icodec to different daily insulins in people with type 2 diabetes. The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App. The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1085 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin icodec with DoseGuide
Arm Type
Experimental
Arm Description
Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
Arm Title
Once daily basal insulin analogues
Arm Type
Active Comparator
Arm Description
Participants randomised to basal insulin analogue injections once daily
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Intervention Description
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine 100U/mL
Intervention Description
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine 300U/mL
Intervention Description
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Primary Outcome Measure Information:
Title
Change in HbA1c (glycated haemoglobin)
Description
%-point
Time Frame
From baseline week 0 (V2) to week 52 (V6)
Secondary Outcome Measure Information:
Title
Time from baseline to treatment discontinuation or intensification
Description
Days
Time Frame
From baseline week 0 (V2) to week 52 (V6)
Title
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction
Description
Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
Time Frame
From baseline week 0 (V2) to week 52 (V6)
Title
Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain
Description
Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.
Time Frame
At end of treatment week 52 (V6)
Title
Number of severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V8)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V8)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V8)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female. Age above or equal to 18 years at the time of signing informed consent. Diagnosed with T2D greater than or equal to 180 days prior to the day of screening. HbA1c above 7.0% (53 mmol/mol) as measured by central lab. Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator. Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products. Previous participation in this trial. Participation is defined as signed informed consent. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening) Any disorder which in the investigator's opinion might jeopardise subject's safety
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
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
Hawthorne
State/Province
California
ZIP/Postal Code
90250
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
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
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
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
West Hills
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-3609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
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
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
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
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
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
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
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3020
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
03060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
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
West Seneca
State/Province
New York
ZIP/Postal Code
14224
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
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681-1538
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
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
Austin
State/Province
Texas
ZIP/Postal Code
78749
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
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 7L3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
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
Nepean
State/Province
Ontario
ZIP/Postal Code
K2J 0V2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 1M1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G4T3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Stoney Creek
State/Province
Ontario
ZIP/Postal Code
L8J 0B6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brossard
State/Province
Quebec
ZIP/Postal Code
J4Z 2K9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saint-Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
St-Marc-des-Carrières
State/Province
Quebec
ZIP/Postal Code
G0A 4B0
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
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
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Falkensee
ZIP/Postal Code
14612
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
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Riesa
ZIP/Postal Code
01587
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
Stuttgart
ZIP/Postal Code
70378
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-115 27
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11526
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-17562
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Larissa
ZIP/Postal Code
GR-41110
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54635
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54636
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54643
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57010
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Komárom
State/Province
Komárom-Esztergom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1132
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4025
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-6725
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-132
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
91-473
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-834
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Staszow
State/Province
Świętokrzyskie
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01000
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Gaziantep
ZIP/Postal Code
27070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Hatay
ZIP/Postal Code
31060
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34760
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Citations:
PubMed Identifier
36106652
Citation
Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.
Results Reference
result

Learn more about this trial

A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

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