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
Active, not recruiting
CT.gov ID
NCT04880850
Collaborator
(none)
578
Enrollment
81
Locations
2
Arms
12.2
Anticipated Duration (Months)
7.1
Patients Per Site
0.6
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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Primary Completion Date :
Mar 11, 2022
Anticipated Study Completion Date :
May 20, 2022

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteConcordCaliforniaUnited States94520
2Novo Nordisk Investigational SiteFresnoCaliforniaUnited States93720
3Novo Nordisk Investigational SiteNorthridgeCaliforniaUnited States91325
4Novo Nordisk Investigational SiteSacramentoCaliforniaUnited States95821
5Novo Nordisk Investigational SiteTustinCaliforniaUnited States92780
6Novo Nordisk Investigational SiteVenturaCaliforniaUnited States93003
7Novo Nordisk Investigational SiteWalnut CreekCaliforniaUnited States94598
8Novo Nordisk Investigational SiteWashingtonDistrict of ColumbiaUnited States20010
9Novo Nordisk Investigational SiteWest Palm BeachFloridaUnited States33401
10Novo Nordisk Investigational SiteLawrencevilleGeorgiaUnited States30046
11Novo Nordisk Investigational SiteNampaIdahoUnited States83686-6011
12Novo Nordisk Investigational SiteJefferson CityMissouriUnited States65109
13Novo Nordisk Investigational SiteOmahaNebraskaUnited States68114
14Novo Nordisk Investigational SiteSyracuseNew YorkUnited States13210
15Novo Nordisk Investigational SiteWest SenecaNew YorkUnited States14224
16Novo Nordisk Investigational SiteGreenvilleNorth CarolinaUnited States27834
17Novo Nordisk Investigational SiteBartlettTennesseeUnited States38133
18Novo Nordisk Investigational SiteKingsportTennesseeUnited States37660
19Novo Nordisk Investigational SiteNashvilleTennesseeUnited States37212
20Novo Nordisk Investigational SiteAmarilloTexasUnited States79106
21Novo Nordisk Investigational SiteAustinTexasUnited States78731
22Novo Nordisk Investigational SiteAustinTexasUnited States78749
23Novo Nordisk Investigational SiteCorpus ChristiTexasUnited States78414
24Novo Nordisk Investigational SiteDallasTexasUnited States75230
25Novo Nordisk Investigational SiteDallasTexasUnited States75231
26Novo Nordisk Investigational SiteDallasTexasUnited States75390-9302
27Novo Nordisk Investigational SiteLongviewTexasUnited States75605
28Novo Nordisk Investigational SiteOlympiaWashingtonUnited States98502
29Novo Nordisk Investigational SiteBonheidenBelgium2820
30Novo Nordisk Investigational SiteBoussuBelgium7300
31Novo Nordisk Investigational SiteBruxellesBelgium1200
32Novo Nordisk Investigational SiteEdegemBelgium2650
33Novo Nordisk Investigational SiteLeuvenBelgium3000
34Novo Nordisk Investigational SiteBangaloreKarnatakaIndia560 017
35Novo Nordisk Investigational SiteBangaloreKarnatakaIndia560034
36Novo Nordisk Investigational SiteBangaloreKarnatakaIndia560043
37Novo Nordisk Investigational SiteBangaloreKarnatakaIndia560092
38Novo Nordisk Investigational SiteKochiKeralaIndia682025
39Novo Nordisk Investigational SiteMumbaiMaharashtraIndia400010
40Novo Nordisk Investigational SiteMumbaiMaharashtraIndia400058
41Novo Nordisk Investigational SiteJaipurRajasthanIndia302006
42Novo Nordisk Investigational SiteBolognaItaly40138
43Novo Nordisk Investigational SiteCatanzaroItaly88100
44Novo Nordisk Investigational SiteChietiItaly66100
45Novo Nordisk Investigational SiteMilanoItaly20132
46Novo Nordisk Investigational SiteNapoliItaly80138
47Novo Nordisk Investigational SiteRomaItaly00161
48Novo Nordisk Investigational SiteFukuoka-shi, FukuokaJapan819-0006
49Novo Nordisk Investigational SiteHokkaidoJapan062-0007
50Novo Nordisk Investigational SiteIbarakiJapan311-0113
51Novo Nordisk Investigational SiteKitakyusyu-shi, FukuokaJapan800-0222
52Novo Nordisk Investigational SiteSaitamaJapan336-0967
53Novo Nordisk Investigational SiteTochigiJapan323-0022
54Novo Nordisk Investigational SiteTokyoJapan105-8471
55Novo Nordisk Investigational SiteUshiku-shi, IbarakiJapan300-1207
56Novo Nordisk Investigational SiteZapopanJaliscoMexico45116
57Novo Nordisk Investigational SiteMonterreyNuevo LeónMexico64460
58Novo Nordisk Investigational SiteApeldoornNetherlands7334 DZ
59Novo Nordisk Investigational SiteArnhemNetherlands6815 AD
60Novo Nordisk Investigational SiteEindhovenNetherlands5631 BM
61Novo Nordisk Investigational SiteHoogeveenNetherlands7909 AA
62Novo Nordisk Investigational SiteMaastrichtNetherlands6229 HX
63Novo Nordisk Investigational SiteRotterdamNetherlands3083 AN
64Novo Nordisk Investigational SiteUtrechtNetherlands3584 CX
65Novo Nordisk Investigational SiteTargovisteDambovitaRomania130086
66Novo Nordisk Investigational SiteTargu MuresMuresRomania540142
67Novo Nordisk Investigational SiteBrasovRomania500101
68Novo Nordisk Investigational SiteBucharestRomania020475
69Novo Nordisk Investigational SiteBuzauRomania120203
70Novo Nordisk Investigational SiteGalatiRomania800578
71Novo Nordisk Investigational SiteArkhangelskRussian Federation163045
72Novo Nordisk Investigational SiteBarnaulRussian Federation656045
73Novo Nordisk Investigational SiteKazanRussian Federation420010
74Novo Nordisk Investigational SiteKirovRussian Federation610014
75Novo Nordisk Investigational SiteKurskRussian Federation305016
76Novo Nordisk Investigational SiteMoscowRussian Federation123182
77Novo Nordisk Investigational SiteMoscowRussian Federation125008
78Novo Nordisk Investigational SiteNovosibirskRussian Federation630099
79Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation191119
80Novo Nordisk Investigational SiteSaratovRussian Federation410039
81Novo Nordisk Investigational SiteTumenRussian Federation625023

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:
Dec 2, 2021
Last Verified:
Dec 1, 2021
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:

Study Results

No Results Posted as of Dec 2, 2021