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A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04880850
Collaborator
(none)
578
Enrollment
83
Locations
2
Arms
13.1
Actual Duration (Months)
7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily.

Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants will get is decided by chance. Participants will also get a mealtime insulin.The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

The study will last for about 8 months. participants will have 17 clinic visits and 13 phone calls with the study doctor.At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin icodec
  • Drug: Insulin glargine
  • Drug: Insulin aspart
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
578 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen
Actual Study Start Date :
May 14, 2021
Actual Primary Completion Date :
Jun 16, 2022
Actual Study Completion Date :
Jun 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: insulin icodec + insulin aspart

Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart

Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

Drug: Insulin aspart
Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks
Active Comparator: Insulin glargine + insulin aspart

Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart

Drug: Insulin glargine
Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks

Drug: Insulin aspart
Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks

Outcome Measures

Primary Outcome Measures

  1. Change in Glycated haemoglobin (HbA1c) [From baseline week 0 (V2) to week 26 (V28)]

    Measured in %-point

Secondary Outcome Measures

  1. Change in fasting plasma glucose (FPG) [From baseline week 0 (V2) to week 26 (V28)]

    Measured in mmol/L

  2. Time in target-range 3.9-10.0 mmol/L (70-180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6) [From week 22 (V24) to week 26 (V28)]

    Measured in % of readings

  3. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 31 (V30)]

    Number of episodes

  4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline week 0 (V2) to week 31 (V30)]

    Number of episodes

  5. 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) [From baseline week 0 (V2) to week 31 (V30)]

    Number of episodes

  6. Time spent below 3.0 mmol/L (54 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6 ) [From week 22 (V24) to week 26 (V28)]

    Measured in % of readings

  7. Time spent above 10 mmol/L (180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6) [From week 22 (V24) to week 26 (V28)]

    Measured in % of readings

  8. Mean weekly insulin dose [From week 24 (V26) to week 26 (V28)]

    Measured in U

  9. Change in body weight [From baseline week 0 (V2) to week 26 (V28)]

    Measured in kg

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female aged above or equal to 18 years at the time of signing informed consent.

  • Diagnosed with type 2 diabetes mellitus (T2D) greater than or equal to 180 days prior to the day of screening.

  • Glycated haemoglobin (HbA1c) from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.

  • Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:

Metformin / Sulfonylureas / Meglitinides (glinides) / DPP-4 inhibitors / SGLT2 inhibitors / Thiazolidinediones / Alpha-glucosidase inhibitors / Oral combination products (for the allowed individual oral anti-diabetic drugs) / Oral or injectable GLP-1-receptor agonists

  • Body mass index (BMI) below or equal to 40.0 kg/m^2.
Exclusion Criteria:

  • Any episodes (as declared by the subject or in the medical records.) of diabetic ketoacidosis within 90 days prior to the day of screening.

  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.

  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.

  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Concord California United States 94520
2 Novo Nordisk Investigational Site Fresno California United States 93720
3 Novo Nordisk Investigational Site Northridge California United States 91325
4 Novo Nordisk Investigational Site Sacramento California United States 95821
5 Novo Nordisk Investigational Site Tustin California United States 92780
6 Novo Nordisk Investigational Site Ventura California United States 93003
7 Novo Nordisk Investigational Site Walnut Creek California United States 94598
8 Novo Nordisk Investigational Site Washington District of Columbia United States 20010
9 Novo Nordisk Investigational Site West Palm Beach Florida United States 33401
10 Novo Nordisk Investigational Site Lawrenceville Georgia United States 30046
11 Novo Nordisk Investigational Site Nampa Idaho United States 83686-6011
12 Novo Nordisk Investigational Site Jefferson City Missouri United States 65109
13 Novo Nordisk Investigational Site Omaha Nebraska United States 68114
14 Novo Nordisk Investigational Site Syracuse New York United States 13210
15 Novo Nordisk Investigational Site West Seneca New York United States 14224
16 Novo Nordisk Investigational Site Greenville North Carolina United States 27834
17 Novo Nordisk Investigational Site Bartlett Tennessee United States 38133
18 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
19 Novo Nordisk Investigational Site Nashville Tennessee United States 37212
20 Novo Nordisk Investigational Site Amarillo Texas United States 79106
21 Novo Nordisk Investigational Site Austin Texas United States 78731
22 Novo Nordisk Investigational Site Austin Texas United States 78749
23 Novo Nordisk Investigational Site Corpus Christi Texas United States 78414
24 Novo Nordisk Investigational Site Dallas Texas United States 75230
25 Novo Nordisk Investigational Site Dallas Texas United States 75231
26 Novo Nordisk Investigational Site Dallas Texas United States 75390-9302
27 Novo Nordisk Investigational Site Longview Texas United States 75605
28 Novo Nordisk Investigational Site Olympia Washington United States 98502
29 Novo Nordisk Investigational Site Bonheiden Belgium 2820
30 Novo Nordisk Investigational Site Boussu Belgium 7300
31 Novo Nordisk Investigational Site Bruxelles Belgium 1200
32 Novo Nordisk Investigational Site Edegem Belgium 2650
33 Novo Nordisk Investigational Site Leuven Belgium 3000
34 Novo Nordisk Investigational Site Bangalore Karnataka India 560 017
35 Novo Nordisk Investigational Site Bangalore Karnataka India 560034
36 Novo Nordisk Investigational Site Bangalore Karnataka India 560043
37 Novo Nordisk Investigational Site Bangalore Karnataka India 560092
38 Novo Nordisk Investigational Site Kochi Kerala India 682025
39 Novo Nordisk Investigational Site Mumbai Maharashtra India 400010
40 Novo Nordisk Investigational Site Mumbai Maharashtra India 400058
41 Novo Nordisk Investigational Site Pune Maharashtra India 411001
42 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
43 Novo Nordisk Investigational Site Jaipur Rajasthan India 302006
44 Novo Nordisk Investigational Site Bologna Italy 40138
45 Novo Nordisk Investigational Site Catanzaro Italy 88100
46 Novo Nordisk Investigational Site Chieti Italy 66100
47 Novo Nordisk Investigational Site Milano Italy 20132
48 Novo Nordisk Investigational Site Napoli Italy 80138
49 Novo Nordisk Investigational Site Roma Italy 00161
50 Novo Nordisk Investigational Site Fukuoka-shi, Fukuoka Japan 819-0006
51 Novo Nordisk Investigational Site Hokkaido Japan 062-0007
52 Novo Nordisk Investigational Site Ibaraki Japan 311-0113
53 Novo Nordisk Investigational Site Kitakyusyu-shi, Fukuoka Japan 800-0222
54 Novo Nordisk Investigational Site Saitama Japan 336-0967
55 Novo Nordisk Investigational Site Tochigi Japan 323-0022
56 Novo Nordisk Investigational Site Tokyo Japan 105-8471
57 Novo Nordisk Investigational Site Ushiku-shi, Ibaraki Japan 300-1207
58 Novo Nordisk Investigational Site Zapopan Jalisco Mexico 45116
59 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64460
60 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
61 Novo Nordisk Investigational Site Arnhem Netherlands 6815 AD
62 Novo Nordisk Investigational Site Eindhoven Netherlands 5631 BM
63 Novo Nordisk Investigational Site Hoogeveen Netherlands 7909 AA
64 Novo Nordisk Investigational Site Maastricht Netherlands 6229 HX
65 Novo Nordisk Investigational Site Rotterdam Netherlands 3083 AN
66 Novo Nordisk Investigational Site Utrecht Netherlands 3584 CX
67 Novo Nordisk Investigational Site Targoviste Dambovita Romania 130086
68 Novo Nordisk Investigational Site Targu Mures Mures Romania 540142
69 Novo Nordisk Investigational Site Brasov Romania 500101
70 Novo Nordisk Investigational Site Bucharest Romania 020475
71 Novo Nordisk Investigational Site Buzau Romania 120203
72 Novo Nordisk Investigational Site Galati Romania 800578
73 Novo Nordisk Investigational Site Arkhangelsk Russian Federation 163045
74 Novo Nordisk Investigational Site Barnaul Russian Federation 656045
75 Novo Nordisk Investigational Site Kazan Russian Federation 420010
76 Novo Nordisk Investigational Site Kirov Russian Federation 610014
77 Novo Nordisk Investigational Site Kursk Russian Federation 305016
78 Novo Nordisk Investigational Site Moscow Russian Federation 123182
79 Novo Nordisk Investigational Site Moscow Russian Federation 125008
80 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630099
81 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191119
82 Novo Nordisk Investigational Site Saratov Russian Federation 410039
83 Novo Nordisk Investigational Site Tumen Russian Federation 625023

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04880850
Other Study ID Numbers:
  • NN1436-4480
  • U1111-1247-5269
  • 2020-000474-16
First Posted:
May 11, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart

Study Results

No Results Posted as of Jul 11, 2022