ONWARDS 1: A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04460885
Collaborator
(none)
984
Enrollment
150
Locations
2
Arms
24.1
Anticipated Duration (Months)
6.6
Patients Per Site
0.3
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 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 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 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 the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). 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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
984 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes
Actual Study Start Date :
Nov 25, 2020
Anticipated Primary Completion Date :
Apr 27, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Insulin icodec

Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic 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 78 weeks.

Active Comparator: Insulin glargine

Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period

Drug: Insulin glargine
Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [From baseline week 0 (V2) to week 52 (V46)]

    %-point

Secondary Outcome Measures

  1. Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

    % of readings

  2. Change in fasting plasma glucose (FPG) [From baseline week 0 (V2) to week 52 (V46)]

    mmol/L

  3. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 52 (V46)]

    Number of episodes

  4. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) [From baseline week 0 (V2) to week 52 (V46)]

    Number of episodes

  5. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 52 (V46)]

    Number of episodes

  6. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 83 (V63)]

    Number of episodes

  7. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) [From baseline week 0 (V2) to week 83 (V63)]

    Number of episodes

  8. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 83 (V63)]

    Number of episodes

  9. Mean weekly insulin dose [From week 50 (V44) to week 52 (V46)]

    U

  10. Change in body weight [From baseline week 0 (V2) to week 52 (V46)]

    kg

  11. Time spent < 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

    % of readings

  12. Time spent > 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

    % of readings

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) 180 days or more prior to the day of screening.

  • HbA1c 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) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose.

  1. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
  • Body mass index (BMI) equal to or below 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 SiteBirminghamAlabamaUnited States35294
2Novo Nordisk Investigational SiteGuntersvilleAlabamaUnited States35967
3Novo Nordisk Investigational SiteBuena ParkCaliforniaUnited States90620
4Novo Nordisk Investigational SiteFresnoCaliforniaUnited States93720
5Novo Nordisk Investigational SiteLancasterCaliforniaUnited States93534
6Novo Nordisk Investigational SitePalm SpringsCaliforniaUnited States92262
7Novo Nordisk Investigational SiteVenturaCaliforniaUnited States93003
8Novo Nordisk Investigational SiteWaterburyConnecticutUnited States06708
9Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32216
10Novo Nordisk Investigational SiteNew Port RicheyFloridaUnited States34652
11Novo Nordisk Investigational SiteOrlandoFloridaUnited States32825
12Novo Nordisk Investigational SitePalm HarborFloridaUnited States34684-3609
13Novo Nordisk Investigational SiteWest Palm BeachFloridaUnited States33401
14Novo Nordisk Investigational SiteWinter HavenFloridaUnited States33880
15Novo Nordisk Investigational SiteLawrencevilleGeorgiaUnited States30046
16Novo Nordisk Investigational SiteHonoluluHawaiiUnited States96814
17Novo Nordisk Investigational SiteChicagoIllinoisUnited States60607
18Novo Nordisk Investigational SiteGurneeIllinoisUnited States60031
19Novo Nordisk Investigational SiteWest Des MoinesIowaUnited States50265
20Novo Nordisk Investigational SiteTopekaKansasUnited States66606
21Novo Nordisk Investigational SitePaducahKentuckyUnited States42001
22Novo Nordisk Investigational SiteHyattsvilleMarylandUnited States20782
23Novo Nordisk Investigational SiteRockvilleMarylandUnited States20852
24Novo Nordisk Investigational SiteTroyMichiganUnited States48098
25Novo Nordisk Investigational SiteOmahaNebraskaUnited States68114
26Novo Nordisk Investigational SiteOmahaNebraskaUnited States68198-3020
27Novo Nordisk Investigational SiteNashuaNew HampshireUnited States03060
28Novo Nordisk Investigational SiteAlbuquerqueNew MexicoUnited States87102
29Novo Nordisk Investigational SiteBrooklynNew YorkUnited States11215
30Novo Nordisk Investigational SiteNew YorkNew YorkUnited States10016
31Novo Nordisk Investigational SiteWest SenecaNew YorkUnited States14224
32Novo Nordisk Investigational SiteGreenvilleNorth CarolinaUnited States27834
33Novo Nordisk Investigational SiteRaleighNorth CarolinaUnited States27609
34Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
35Novo Nordisk Investigational SiteFargoNorth DakotaUnited States58104
36Novo Nordisk Investigational SiteCantonOhioUnited States44718
37Novo Nordisk Investigational SiteDaytonOhioUnited States45439
38Novo Nordisk Investigational SiteFranklinOhioUnited States45005
39Novo Nordisk Investigational SiteNormanOklahomaUnited States73069
40Novo Nordisk Investigational SiteMurrells InletSouth CarolinaUnited States29576
41Novo Nordisk Investigational SiteSimpsonvilleSouth CarolinaUnited States29681-1538
42Novo Nordisk Investigational SiteKingsportTennesseeUnited States37660
43Novo Nordisk Investigational SiteAustinTexasUnited States78731
44Novo Nordisk Investigational SiteDallasTexasUnited States75230
45Novo Nordisk Investigational SiteDallasTexasUnited States75390-9302
46Novo Nordisk Investigational SiteHoustonTexasUnited States77024
47Novo Nordisk Investigational SiteHoustonTexasUnited States77074
48Novo Nordisk Investigational SiteLampasasTexasUnited States76550
49Novo Nordisk Investigational SiteLive OakTexasUnited States78233
50Novo Nordisk Investigational SiteRound RockTexasUnited States78681
51Novo Nordisk Investigational SiteSan AntonioTexasUnited States78229
52Novo Nordisk Investigational SiteSugar LandTexasUnited States77478
53Novo Nordisk Investigational SiteBountifulUtahUnited States84010
54Novo Nordisk Investigational SiteOgdenUtahUnited States84405
55Novo Nordisk Investigational SiteSaint GeorgeUtahUnited States84790
56Novo Nordisk Investigational SiteNewport NewsVirginiaUnited States23606
57Novo Nordisk Investigational SiteRentonWashingtonUnited States98057
58Novo Nordisk Investigational SiteKarlovacCroatia47000
59Novo Nordisk Investigational SiteOsijekCroatia31000
60Novo Nordisk Investigational SiteRijekaCroatia51000
61Novo Nordisk Investigational SiteVarazdinCroatia42 000
62Novo Nordisk Investigational SiteHyderabadAndhra PradeshIndia500072
63Novo Nordisk Investigational SiteRohtakHaryanaIndia124001
64Novo Nordisk Investigational SiteIndoreMadhya PradeshIndia452010
65Novo Nordisk Investigational SiteMumbaiMaharashtraIndia400008
66Novo Nordisk Investigational SitePuneMaharashtraIndia411021
67Novo Nordisk Investigational SiteNew DehliNew DelhiIndia110029
68Novo Nordisk Investigational SiteChennaiTamil NaduIndia600086
69Novo Nordisk Investigational SiteVelloreTamil NaduIndia632004
70Novo Nordisk Investigational SiteHyderabadTelenganaIndia500003
71Novo Nordisk Investigational SiteHyderbadTelenganaIndia500 012
72Novo Nordisk Investigational SiteHolonIsrael58100
73Novo Nordisk Investigational SiteJerusalemIsrael91120
74Novo Nordisk Investigational SiteKfar SabaIsrael44281
75Novo Nordisk Investigational SitePetach TikvaIsrael49100
76Novo Nordisk Investigational SiteRehovotIsrael76100
77Novo Nordisk Investigational SiteBergamoItaly24127
78Novo Nordisk Investigational SiteCatanzaroItaly88100
79Novo Nordisk Investigational SiteMilanoItaly20122
80Novo Nordisk Investigational SitePalermoItaly90127
81Novo Nordisk Investigational SiteRomaItaly00161
82Novo Nordisk Investigational SiteBunkyo-ku, TokyoJapan113-8655
83Novo Nordisk Investigational SiteChibaJapan261-0004
84Novo Nordisk Investigational SiteChigasaki-shi, KanagawaJapan253-0044
85Novo Nordisk Investigational SiteFukuoka-shi, FukuokaJapan819-0006
86Novo Nordisk Investigational SiteIbarakiJapan311-0113
87Novo Nordisk Investigational SiteKitakyusyu-shi, FukuokaJapan800-0222
88Novo Nordisk Investigational SiteMinato-ku, TokyoJapan105-8470
89Novo Nordisk Investigational SiteMiyagiJapan983-0039
90Novo Nordisk Investigational SiteMiyazakiJapan880-0034
91Novo Nordisk Investigational SiteSaitamaJapan336-0967
92Novo Nordisk Investigational SiteShimotsuke-shi, TochigiJapan329-0433
93Novo Nordisk Investigational SiteTochigiJapan323-0022
94Novo Nordisk Investigational SiteUshiku-shi, IbarakiJapan300-1207
95Novo Nordisk Investigational SiteGuadalajaraJaliscoMexico64460
96Novo Nordisk Investigational SiteMexico CityMéxico, D.F.Mexico06700
97Novo Nordisk Investigational SiteMonterreyNuevo LeónMexico64460
98Novo Nordisk Investigational SiteHermosilloSonoraMexico83280
99Novo Nordisk Investigational SiteBialystokPoland15-435
100Novo Nordisk Investigational SiteGorzow WielkopolskiPoland66-400
101Novo Nordisk Investigational SiteLublinPoland20-044
102Novo Nordisk Investigational SiteLublinPoland20-538
103Novo Nordisk Investigational SiteRadomPoland26-600
104Novo Nordisk Investigational SiteWarsawPoland00-465
105Novo Nordisk Investigational SiteWierzchoslawicePoland33-122
106Novo Nordisk Investigational SiteZabrzePoland41-800
107Novo Nordisk Investigational SiteBayamonPuerto Rico00961
108Novo Nordisk Investigational SiteManatiPuerto Rico00674
109Novo Nordisk Investigational SiteKemerovoRussian Federation650066
110Novo Nordisk Investigational SiteMoscowRussian Federation117036
111Novo Nordisk Investigational SiteMoscowRussian Federation119435
112Novo Nordisk Investigational SiteNovosibirskRussian Federation630099
113Novo Nordisk Investigational SiteNovosibirskRussian Federation630117
114Novo Nordisk Investigational SitePenzaRussian Federation440026
115Novo Nordisk Investigational SiteSaint PetersburgRussian Federation194291
116Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation194156
117Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation194356
118Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation197110
119Novo Nordisk Investigational SiteSaratovRussian Federation410039
120Novo Nordisk Investigational SiteTomskRussian Federation634050
121Novo Nordisk Investigational SiteVoronezhRussian Federation394018
122Novo Nordisk Investigational SiteYoshkar-OlaRussian Federation424004
123Novo Nordisk Investigational SiteBratislavaSlovakia821 02
124Novo Nordisk Investigational SiteBratislavaSlovakia84102
125Novo Nordisk Investigational SiteBratislavaSlovakia851 01
126Novo Nordisk Investigational SiteMalackySlovakia901 01
127Novo Nordisk Investigational SiteMalackySlovakia90101
128Novo Nordisk Investigational SiteMoldava nad BodvouSlovakia045 01
129Novo Nordisk Investigational SiteSahySlovakia93601
130Novo Nordisk Investigational SiteTrebisovSlovakia07501
131Novo Nordisk Investigational SiteLa CoruñaSpain15006
132Novo Nordisk Investigational SiteLa Roca del VallésSpain08430
133Novo Nordisk Investigational SiteMadridSpain28006
134Novo Nordisk Investigational SiteMadridSpain28020
135Novo Nordisk Investigational SitePozuelo de AlarconSpain28223
136Novo Nordisk Investigational SiteBlackpoolUnited KingdomFY3 7EN
137Novo Nordisk Investigational SiteBollingtonUnited KingdomSK10 5JH
138Novo Nordisk Investigational SiteBradford-on-AvonUnited KingdomBA15 1DQ
139Novo Nordisk Investigational SiteBristolUnited KingdomBS10 5NB
140Novo Nordisk Investigational SiteCambridgeUnited KingdomCB2 0QQ
141Novo Nordisk Investigational SiteChesterUnited KingdomCH2 1UL
142Novo Nordisk Investigational SiteDorsetUnited KingdomBH16 5PW
143Novo Nordisk Investigational SiteDundeeUnited KingdomDD1 9SY
144Novo Nordisk Investigational SiteEdinburghUnited KingdomEH4 2XU
145Novo Nordisk Investigational SiteHigh WycombeUnited KingdomHP11 2TT
146Novo Nordisk Investigational SiteHinckleyUnited KingdomLE10 2SE
147Novo Nordisk Investigational SiteSohamUnited KingdomCB7 5JD
148Novo Nordisk Investigational SiteSwanseaUnited KingdomSA2 8PP
149Novo Nordisk Investigational SiteTruroUnited KingdomTR1 3LJ
150Novo Nordisk Investigational SiteWellingboroughUnited KingdomNN8 4RW

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (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:
NCT04460885
Other Study ID Numbers:
  • NN1436-4477
  • U1111-1247-3878
  • 2020-000442-34
First Posted:
Jul 8, 2020
Last Update Posted:
Nov 30, 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 30, 2021