ONWARDS 2: A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04770532
Collaborator
(none)
520
Enrollment
72
Locations
2
Arms
12.2
Anticipated Duration (Months)
7.2
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 degludec (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 degludec 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 degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.

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 degludec
  • Drug: Insulin Icodec
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
520 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 Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin
Actual Study Start Date :
Mar 5, 2021
Anticipated Primary Completion Date :
Jan 27, 2022
Anticipated Study Completion Date :
Mar 10, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Insulin icodec

Insulin icodeg + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.

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

Active Comparator: Insulin degludec

Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.

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

Outcome Measures

Primary Outcome Measures

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

    %-point

Secondary Outcome Measures

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

    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)]

    % of readings

  3. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [From baseline week 0 (V2) to week 26 (V28)]

    Score 0-36 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment

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

    Number of episodes

  6. 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

  7. 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)]

    % of readings

  8. 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)]

    % of readings

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

    U

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

    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 T2D greater than or equal to 180 days prior to the day of screening.

  • 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 or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): 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 SiteBuena ParkCaliforniaUnited States90620
2Novo Nordisk Investigational SiteFresnoCaliforniaUnited States93720
3Novo Nordisk Investigational SiteLa JollaCaliforniaUnited States92037
4Novo Nordisk Investigational SiteLincolnCaliforniaUnited States95648
5Novo Nordisk Investigational SiteNorthridgeCaliforniaUnited States91325
6Novo Nordisk Investigational SitePalm SpringsCaliforniaUnited States92262
7Novo Nordisk Investigational SiteWalnut CreekCaliforniaUnited States94598
8Novo Nordisk Investigational SiteOcalaFloridaUnited States34470
9Novo Nordisk Investigational SitePembroke PinesFloridaUnited States33027
10Novo Nordisk Investigational SiteRoswellGeorgiaUnited States30076
11Novo Nordisk Investigational SiteValparaisoIndianaUnited States46383
12Novo Nordisk Investigational SiteNew OrleansLouisianaUnited States70119
13Novo Nordisk Investigational SiteSlidellLouisianaUnited States70461-4231
14Novo Nordisk Investigational SiteRockvilleMarylandUnited States20852
15Novo Nordisk Investigational SiteWalthamMassachusettsUnited States02453
16Novo Nordisk Investigational SiteAlbanyNew YorkUnited States12203
17Novo Nordisk Investigational SiteGreensboroNorth CarolinaUnited States27408
18Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
19Novo Nordisk Investigational SiteAmarilloTexasUnited States79106
20Novo Nordisk Investigational SiteDallasTexasUnited States75230
21Novo Nordisk Investigational SiteFort WorthTexasUnited States76132
22Novo Nordisk Investigational SiteHoustonTexasUnited States77079
23Novo Nordisk Investigational SiteSan AntonioTexasUnited States78215
24Novo Nordisk Investigational SiteSugar LandTexasUnited States77478
25Novo Nordisk Investigational SiteWacoTexasUnited States76708
26Novo Nordisk Investigational SiteOlympiaWashingtonUnited States98502
27Novo Nordisk Investigational SiteKyustendilBulgaria2500
28Novo Nordisk Investigational SitePlovdivBulgaria4002
29Novo Nordisk Investigational SiteRuseBulgaria7002
30Novo Nordisk Investigational SiteSofiaBulgaria1606
31Novo Nordisk Investigational SiteEssenGermany45136
32Novo Nordisk Investigational SiteHamburgGermany22607
33Novo Nordisk Investigational SiteHohenmölsenGermany06679
34Novo Nordisk Investigational SiteMünsterGermany48145
35Novo Nordisk Investigational SiteRehlingen-SiersburgGermany66780
36Novo Nordisk Investigational SiteStuttgartGermany70199
37Novo Nordisk Investigational SiteStuttgartGermany70378
38Novo Nordisk Investigational SiteChibaJapan261-0004
39Novo Nordisk Investigational SiteChigasaki-shi, KanagawaJapan253-0044
40Novo Nordisk Investigational SiteFukuoka-shi, FukuokaJapan819-0006
41Novo Nordisk Investigational SiteIbarakiJapan311-0113
42Novo Nordisk Investigational SiteMiyazakiJapan880-0034
43Novo Nordisk Investigational SiteSapporo-shi, HokkaidoJapan060-0001
44Novo Nordisk Investigational SiteTochigiJapan323-0022
45Novo Nordisk Investigational SiteTokyoJapan113-8431
46Novo Nordisk Investigational SiteUshiku-shi, IbarakiJapan300-1207
47Novo Nordisk Investigational SiteGyeonggi-doKorea, Republic of13620
48Novo Nordisk Investigational SiteSeoulKorea, Republic of02841
49Novo Nordisk Investigational SiteSeoulKorea, Republic of03080
50Novo Nordisk Investigational SiteSeoulKorea, Republic of03181
51Novo Nordisk Investigational SiteSeoulKorea, Republic of03722
52Novo Nordisk Investigational SiteSeoulKorea, Republic of139-827
53Novo Nordisk Investigational SiteSuwon-si, Gyeonggi-doKorea, Republic of16247
54Novo Nordisk Investigational SiteLodzPoland90-242
55Novo Nordisk Investigational SitePoznanPoland60-821
56Novo Nordisk Investigational SiteWarszawaPoland02-507
57Novo Nordisk Investigational SiteAlmadaPortugal2805-267
58Novo Nordisk Investigational SiteLisboaPortugal1349-019
59Novo Nordisk Investigational SiteMatosinhosPortugal4464-513
60Novo Nordisk Investigational SitePortoPortugal4099-001
61Novo Nordisk Investigational SitePortoPortugal4200-319
62Novo Nordisk Investigational SiteVila Nova de GaiaPortugal4400-346
63Novo Nordisk Investigational SitePort ElizabethEastern CapeSouth Africa6045
64Novo Nordisk Investigational SiteBloemfonteinFree StateSouth Africa9301
65Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa1827
66Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa2013
67Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa2198
68Novo Nordisk Investigational SiteDurbanKwaZulu-NatalSouth Africa4092
69Novo Nordisk Investigational SiteDniproUkraine49038
70Novo Nordisk Investigational SiteKyivUkraine04053
71Novo Nordisk Investigational SiteKyivUkraine04114
72Novo Nordisk Investigational SiteTernopilUkraine46001

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:
NCT04770532
Other Study ID Numbers:
  • NN1436-4478
  • U1111-1247-4945
  • 2020-000454-10
First Posted:
Feb 25, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 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 Nov 16, 2021