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)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin icodec; Drug: Insulin Glargine 100U/mL; Drug: Insulin Degludec; Drug: Insulin Glargine 300U/mL

• Study Type: Interventional
• Enrollment (Actual): 1085
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1G 3Y8
    • Novo Nordisk Investigational Site
  • Quebec, Canada, G1V 4T3
    • Novo Nordisk Investigational Site
  • Quebec, Canada, G1W 4R4
    • Novo Nordisk Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
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    • Red Deer, Alberta, Canada, T4N 6V7
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  • British Columbia
    • Victoria, British Columbia, Canada, V8V 4A1
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  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 4W3
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    • Winnipeg, Manitoba, Canada, R3C 0N2
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  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
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  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
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  • Ontario
    • Barrie, Ontario, Canada, L4N 7L3
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    • Brampton, Ontario, Canada, L6S 0C6
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    • Concord, Ontario, Canada, L4K 4M2
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    • Etobicoke, Ontario, Canada, M9R 4E1
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    • Hamilton, Ontario, Canada, L8L 5G8
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    • Hamilton, Ontario, Canada, L8M 1K7
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    • London, Ontario, Canada, N5W 6A2
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    • London, Ontario, Canada, N6G 2M1
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    • Nepean, Ontario, Canada, K2J 0V2
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    • Oakville, Ontario, Canada, L6M 1M1
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    • Oshawa, Ontario, Canada, L1G4T3
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    • Sarnia, Ontario, Canada, N7T 4X3
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    • Stoney Creek, Ontario, Canada, L8J 0B6
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    • Toronto, Ontario, Canada, M4G 3E8
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    • Toronto, Ontario, Canada, M9V 4B4
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  • Quebec
    • Brossard, Quebec, Canada, J4Z 2K9
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    • Chicoutimi, Quebec, Canada, G7H 7K9
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    • Laval, Quebec, Canada, H7T 2P5
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    • Mirabel, Quebec, Canada, J7J 2K8
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    • Montreal, Quebec, Canada, H4T 1Z9
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    • Montreal, Quebec, Canada, H4A 3T2
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    • Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
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    • St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
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    • Victoriaville, Quebec, Canada, G6P 6P6
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• Germany
  • Bad Mergentheim, Germany, 97980
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  • Berlin, Germany, 13597
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  • Essen, Germany, 45136
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  • Falkensee, Germany, 14612
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  • Hamburg, Germany, 22607
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  • Hohenmölsen, Germany, 06679
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  • Münster, Germany, 48145
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  • Münster, Germany, 48153
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  • Oldenburg in Holstein, Germany, 23758
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  • Rehlingen-Siersburg, Germany, 66780
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  • Riesa, Germany, 01587
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  • Saint Ingbert-Oberwürzbach, Germany, 66386
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  • Stuttgart, Germany, 70378
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  • Wangen, Germany, 88239
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• Greece
  • Athens, Greece, GR-17562
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  • Athens, Greece, GR-11527
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  • Athens, Greece, 115 25
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  • Athens, Greece, GR-115 27
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  • Athens, Greece, GR-11526
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  • Larissa, Greece, GR-41110
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  • Thessaloniki, Greece, GR-54636
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  • Thessaloniki, Greece, GR-57010
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  • Thessaloniki, Greece, GR-57001
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  • Thessaloniki, Greece, GR-54635
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  • Thessaloniki, Greece, GR-54642
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  • Thessaloniki, Greece, GR-54643
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• Hungary
  • Budapest, Hungary, 1032
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  • Budapest, Hungary, 1036
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  • Budapest, Hungary, 1042
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  • Budapest, Hungary, 1089
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  • Budapest, Hungary, 1132
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  • Budapest, Hungary, 1134
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  • Budapest, Hungary, 1152
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  • Debrecen, Hungary, 4025
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  • Kaposvár, Hungary, 7400
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  • Szeged, Hungary, H-6725
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  • Szombathely, Hungary, H-9700
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  • Zalaegerszeg, Hungary, 8900
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  • Komárom-Esztergom
    • Komárom, Komárom-Esztergom, Hungary, 2900
      • Novo Nordisk Investigational Site
• Poland
  • Gdansk, Poland, 80-858
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  • Katowice, Poland, 40-081
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  • Lodz, Poland, 90-132
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  • Lodz, Poland, 91-473
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  • Lublin, Poland, 20-081
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  • Poznan, Poland, 60-834
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  • Pulawy, Poland, 24-100
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  • Swidnik, Poland, 21-040
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  • Zabrze, Poland, 41-800
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  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-338
      • Novo Nordisk Investigational Site
  • Świętokrzyskie
    • Staszow, Świętokrzyskie, Poland, 28-200
      • Novo Nordisk Investigational Site
• Puerto Rico
  • Manati, Puerto Rico, 00674
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• Turkey
  • Adana, Turkey, 01250
    • Novo Nordisk Investigational Site
  • Adana, Turkey, 01000
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  • Ankara, Turkey, 06100
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  • Gaziantep, Turkey, 27070
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  • Hatay, Turkey, 31060
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34722
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34390
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34303
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34718
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34371
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34760
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34899
    • Novo Nordisk Investigational Site
  • Izmir, Turkey, 35340
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  • Kayseri, Turkey, 38039
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Novo Nordisk Investigational Site
    • Guntersville, Alabama, United States, 35976
      • Novo Nordisk Investigational Site
  • California
    • Buena Park, California, United States, 90620
      • Novo Nordisk Investigational Site
    • Fresno, California, United States, 93720
      • Novo Nordisk Investigational Site
    • Hawthorne, California, United States, 90250
      • Novo Nordisk Investigational Site
    • Huntington Beach, California, United States, 92648
      • Novo Nordisk Investigational Site
    • La Jolla, California, United States, 92037
      • Novo Nordisk Investigational Site
    • Lancaster, California, United States, 93534
      • Novo Nordisk Investigational Site
    • Lomita, California, United States, 90717
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91325
      • Novo Nordisk Investigational Site
    • Palm Springs, California, United States, 92262
      • Novo Nordisk Investigational Site
    • Sacramento, California, United States, 95821
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92111
      • Novo Nordisk Investigational Site
    • San Ramon, California, United States, 94583
      • Novo Nordisk Investigational Site
    • Spring Valley, California, United States, 91978
      • Novo Nordisk Investigational Site
    • Ventura, California, United States, 93003
      • Novo Nordisk Investigational Site
    • West Hills, California, United States, 91304
      • Novo Nordisk Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
    • Mount Dora, Florida, United States, 32757
      • Novo Nordisk Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32825
      • Novo Nordisk Investigational Site
    • Palm Harbor, Florida, United States, 34684-3609
      • Novo Nordisk Investigational Site
    • Palm Harbor, Florida, United States, 34684
      • Novo Nordisk Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • Novo Nordisk Investigational Site
    • Winter Haven, Florida, United States, 33880
      • Novo Nordisk Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Novo Nordisk Investigational Site
    • Roswell, Georgia, United States, 30076
      • Novo Nordisk Investigational Site
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
    • Springfield, Illinois, United States, 62711
      • Novo Nordisk Investigational Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novo Nordisk Investigational Site
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Novo Nordisk Investigational Site
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Novo Nordisk Investigational Site
    • Troy, Michigan, United States, 48098
      • Novo Nordisk Investigational Site
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Novo Nordisk Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Novo Nordisk Investigational Site
    • Omaha, Nebraska, United States, 68198-3020
      • Novo Nordisk Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Novo Nordisk Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12203
      • Novo Nordisk Investigational Site
    • Brooklyn, New York, United States, 11215
      • Novo Nordisk Investigational Site
    • New Windsor, New York, United States, 12553
      • Novo Nordisk Investigational Site
    • Smithtown, New York, United States, 11787
      • Novo Nordisk Investigational Site
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • Novo Nordisk Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Novo Nordisk Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Novo Nordisk Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Novo Nordisk Investigational Site
    • Dayton, Ohio, United States, 45439
      • Novo Nordisk Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • Novo Nordisk Investigational Site
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • Novo Nordisk Investigational Site
    • Simpsonville, South Carolina, United States, 29681-1538
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • Novo Nordisk Investigational Site
    • Chattanooga, Tennessee, United States, 37404
      • Novo Nordisk Investigational Site
    • Chattanooga, Tennessee, United States, 37411
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    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
    • Morristown, Tennessee, United States, 37813
      • Novo Nordisk Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Novo Nordisk Investigational Site
    • Austin, Texas, United States, 78731
      • Novo Nordisk Investigational Site
    • Austin, Texas, United States, 78749
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-9302
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77024
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77074
      • Novo Nordisk Investigational Site
    • Hurst, Texas, United States, 76054
      • Novo Nordisk Investigational Site
    • Katy, Texas, United States, 77450
      • Novo Nordisk Investigational Site
    • Lampasas, Texas, United States, 76550
      • Novo Nordisk Investigational Site
    • Laredo, Texas, United States, 78041
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    • Live Oak, Texas, United States, 78233
      • Novo Nordisk Investigational Site
    • Round Rock, Texas, United States, 78681
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78229
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    • Sugar Land, Texas, United States, 77478
      • Novo Nordisk Investigational Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • Novo Nordisk Investigational Site
    • Saint George, Utah, United States, 84790
      • Novo Nordisk Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin icodec with DoseGuide; Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.	Drug: Insulin icodec; Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Active Comparator: Once daily basal insulin analogues; Participants randomised to basal insulin analogue injections once daily	Drug: Insulin Glargine 100U/mL; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.; Drug: Insulin Degludec; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.; Drug: Insulin Glargine 300U/mL; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (glycated haemoglobin)	%-point	From baseline week 0 (V2) to week 52 (V6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from baseline to treatment discontinuation or intensification	Days	From baseline week 0 (V2) to week 52 (V6)
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.	From baseline week 0 (V2) to week 52 (V6)
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.	At end of treatment week 52 (V6)
Number of severe hypoglycaemic episodes (level 3)	Number of episodes	From baseline week 0 (V2) to week 57 (V8)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)	Number of episodes	From baseline week 0 (V2) to week 57 (V8)
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	From baseline week 0 (V2) to week 57 (V8)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: NN1436-4481; U1111-1247-5279 (Other Identifier: World Health Organization (WHO)); 2020-000476-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No