A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04795531
Collaborator
(none)
574
Enrollment
98
Locations
2
Arms
14.9
Anticipated Duration (Months)
5.9
Patients Per Site
0.4
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 get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 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.

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: Placebo insulin icodec
  • Drug: Insulin degludec
  • Drug: Placebo insulin degludec
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
574 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.
Actual Study Start Date :
Mar 24, 2021
Anticipated Primary Completion Date :
May 17, 2022
Anticipated Study Completion Date :
Jun 21, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Once weekly insulin icodec + once daily placebo

Participants will get once daily and once weekly injections

Drug: Insulin icodec
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Drug: Placebo insulin degludec
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Experimental: Once weekly placebo and once daily insulin degludec

Participants will get once daily and once weekly injections

Drug: Placebo insulin icodec
You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Drug: Insulin degludec
You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

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

    Number of episodes

  3. 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

  4. 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

  5. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 26 (V28)]

    Number of episodes

  6. 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 26 (V28)]

    Number of episodes

  7. 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 26 (V28)]

    Number of episodes

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

    Kg

  9. Mean weekly insulin dose [From week 24 (P26) to week 26 (V28)]

    U

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 (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.

  • HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.

  • 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 anti-diabetic 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 oral anti-diabetic 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).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - 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 (NYHA) 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 SiteGuntersvilleAlabamaUnited States35967
2Novo Nordisk Investigational SiteBuena ParkCaliforniaUnited States90620
3Novo Nordisk Investigational SiteEscondidoCaliforniaUnited States92025
4Novo Nordisk Investigational SiteFresnoCaliforniaUnited States93720
5Novo Nordisk Investigational SiteLancasterCaliforniaUnited States93534
6Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32216
7Novo Nordisk Investigational SitePalm HarborFloridaUnited States34684-3609
8Novo Nordisk Investigational SiteWest Palm BeachFloridaUnited States33401
9Novo Nordisk Investigational SiteChicagoIllinoisUnited States60607
10Novo Nordisk Investigational SiteTopekaKansasUnited States66606-2806
11Novo Nordisk Investigational SiteTroyMichiganUnited States48098
12Novo Nordisk Investigational SiteOmahaNebraskaUnited States68198-3020
13Novo Nordisk Investigational SiteBrooklynNew YorkUnited States11215
14Novo Nordisk Investigational SiteWest SenecaNew YorkUnited States14224
15Novo Nordisk Investigational SiteGreenvilleNorth CarolinaUnited States27834
16Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
17Novo Nordisk Investigational SiteCantonOhioUnited States44718
18Novo Nordisk Investigational SiteDaytonOhioUnited States45439
19Novo Nordisk Investigational SiteFranklinOhioUnited States45005
20Novo Nordisk Investigational SiteNormanOklahomaUnited States73069
21Novo Nordisk Investigational SiteSimpsonvilleSouth CarolinaUnited States29681-1538
22Novo Nordisk Investigational SiteKingsportTennesseeUnited States37660
23Novo Nordisk Investigational SiteDallasTexasUnited States75230
24Novo Nordisk Investigational SiteDallasTexasUnited States75390-9302
25Novo Nordisk Investigational SiteHoustonTexasUnited States77024
26Novo Nordisk Investigational SiteRound RockTexasUnited States78681
27Novo Nordisk Investigational SiteSan AntonioTexasUnited States78229
28Novo Nordisk Investigational SiteSaint GeorgeUtahUnited States84790
29Novo Nordisk Investigational SiteRentonWashingtonUnited States98057
30Novo Nordisk Investigational SiteBuenos AiresArgentinaC1023AAB
31Novo Nordisk Investigational SiteCabaArgentinaC1060ABA
32Novo Nordisk Investigational SiteCabaArgentinaC1440AAD
33Novo Nordisk Investigational SiteMendozaArgentina5500
34Novo Nordisk Investigational SiteGrazAustria8036
35Novo Nordisk Investigational SiteLinzAustria4021
36Novo Nordisk Investigational SiteWienAustria1120
37Novo Nordisk Investigational SiteWienAustria1130
38Novo Nordisk Investigational SiteWienAustria1140
39Novo Nordisk Investigational SiteCuritibaParanaBrazil80045-170
40Novo Nordisk Investigational SiteCuritibaParanaBrazil80810-040
41Novo Nordisk Investigational SitePorto AlegreRio Grande Do SulBrazil90430-001
42Novo Nordisk Investigational SiteSão PauloSao PauloBrazil01228-000
43Novo Nordisk Investigational SiteWinnipegManitobaCanadaR3C 0N2
44Novo Nordisk Investigational SiteMount PearlNewfoundland and LabradorCanadaA1N 1W7
45Novo Nordisk Investigational SiteSt. JohnsNewfoundland and LabradorCanadaA1B 3V6
46Novo Nordisk Investigational SiteBarrieOntarioCanadaL4N 7L3
47Novo Nordisk Investigational SiteBramptonOntarioCanadaL6S 0C6
48Novo Nordisk Investigational SiteConcordOntarioCanadaL4K 4M2
49Novo Nordisk Investigational SiteEtobicokeOntarioCanadaM9R 4E1
50Novo Nordisk Investigational SiteLondonOntarioCanadaN6G 2M1
51Novo Nordisk Investigational SiteNepeanOntarioCanadaK2J 0V2
52Novo Nordisk Investigational SiteSarniaOntarioCanadaN7T 4X3
53Novo Nordisk Investigational SiteTorontoOntarioCanadaM4G 3E8
54Novo Nordisk Investigational SiteTorontoOntarioCanadaM9V 4B4
55Novo Nordisk Investigational SiteBrossardQuebecCanadaJ4Z 2K9
56Novo Nordisk Investigational SiteMontrealQuebecCanadaH1Y 3L1
57Novo Nordisk Investigational SiteMontrealQuebecCanadaH4T 1Z9
58Novo Nordisk Investigational SiteVictoriavilleQuebecCanadaG6P 6P6
59Novo Nordisk Investigational SiteBeijingBeijingChina100853
60Novo Nordisk Investigational SiteBeijingBeijingChina101200
61Novo Nordisk Investigational SiteChongQingChongqingChina404000
62Novo Nordisk Investigational SiteCangzhouHebeiChina061000
63Novo Nordisk Investigational SiteHengshuiHebeiChina053000
64Novo Nordisk Investigational SiteChangzhouJiangsuChina213003
65Novo Nordisk Investigational SiteNanjingJiangsuChina210011
66Novo Nordisk Investigational SiteNanjingJiangsuChina211106
67Novo Nordisk Investigational SiteZhenjiangJiangsuChina212001
68Novo Nordisk Investigational SiteJinanShandongChina250013
69Novo Nordisk Investigational SiteShanghaiShanghaiChina200072
70Novo Nordisk Investigational SiteShanghaiShanghaiChina200240
71Novo Nordisk Investigational SiteTianjinTianjinChina300052
72Novo Nordisk Investigational SiteKunmingYunnanChina650101
73Novo Nordisk Investigational SiteBroumovCzechia550 01
74Novo Nordisk Investigational SitePardubiceCzechia530 02
75Novo Nordisk Investigational SitePlzeňCzechia301 00
76Novo Nordisk Investigational SitePraha 1Czechia110 00
77Novo Nordisk Investigational SitePraha 5Czechia150 00
78Novo Nordisk Investigational SitePrahaCzechia160 00
79Novo Nordisk Investigational SiteAarhus NDenmark8200
80Novo Nordisk Investigational SiteEsbjergDenmark6700
81Novo Nordisk Investigational SiteHellerupDenmark2900
82Novo Nordisk Investigational SiteHvidovreDenmark2650
83Novo Nordisk Investigational SiteLe CoudrayFrance28630
84Novo Nordisk Investigational SiteLyonFrance69008
85Novo Nordisk Investigational SiteNarbonneFrance11100
86Novo Nordisk Investigational SiteParisFrance75877
87Novo Nordisk Investigational SitePessacFrance33600
88Novo Nordisk Investigational SitePierre BeniteFrance69310
89Novo Nordisk Investigational SiteTOULOUSE cedexFrance31054
90Novo Nordisk Investigational SiteVenissieuxFrance69200
91Novo Nordisk Investigational SiteGuadalajaraJaliscoMexico44650
92Novo Nordisk Investigational SiteHermosilloSonoraMexico83280
93Novo Nordisk Investigational SiteBayamonPuerto Rico00961
94Novo Nordisk Investigational SiteChanghua CityTaiwan500
95Novo Nordisk Investigational SiteTaichung CityTaiwan402
96Novo Nordisk Investigational SiteTaichungTaiwan407
97Novo Nordisk Investigational SiteTainan cityTaiwan710
98Novo Nordisk Investigational SiteTaipeiTaiwan112

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:
NCT04795531
Other Study ID Numbers:
  • NN1436-4479
  • U1111-1247-5218
  • 2020-000472-37
First Posted:
Mar 12, 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