ONWARDS 5: A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins 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
NCT04760626
Collaborator
(none)
1,096
Enrollment
200
Locations
2
Arms
16.8
Anticipated Duration (Months)
5.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

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 100U/mL
  • Drug: Insulin Degludec
  • Drug: Insulin Glargine 300U/mL
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1096 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Jul 25, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Insulin icodec with DoseGuide

Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.

Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.

Active Comparator: Once daily basal insulin analogues

Participants randomised to basal insulin analogue injections once daily

Drug: Insulin Glargine 100U/mL
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Drug: Insulin Degludec
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Drug: Insulin Glargine 300U/mL
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c (glycated haemoglobin) [From baseline week 0 (V2) to week 52 (V6)]

    %-point

Secondary Outcome Measures

  1. Time from baseline to treatment discontinuation or intensification [From baseline week 0 (V2) to week 52 (V6)]

    Days

  2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [From baseline week 0 (V2) to week 52 (V6)]

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

  3. Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain [At end of treatment week 52 (V6)]

    Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.

  4. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 57 (V8)]

    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 57 (V8)]

    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 57 (V8)]

    Number of episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

  • Male or female.

  • Age 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 above 7.0% (53 mmol/mol) as measured by central lab.

  • 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 antidiabetic 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 non-insulin antidiabetic 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):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists

  • Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:
  • Known or suspected hypersensitivity to trial product(s) or related products.

  • Previous participation in this trial. Participation is defined as signed informed consent.

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).

  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)

  • Any disorder which in the investigator's opinion might jeopardise subject's safety

Contacts and Locations

Locations

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1Novo Nordisk Investigational SiteBirminghamAlabamaUnited States35233
2Novo Nordisk Investigational SiteGuntersvilleAlabamaUnited States35967
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149Novo Nordisk Investigational SiteThessalonikiGreeceGR-54636
150Novo Nordisk Investigational SiteThessalonikiGreeceGR-54642
151Novo Nordisk Investigational SiteThessalonikiGreeceGR-54643
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154Novo Nordisk Investigational SiteBudapestHungary1032
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159Novo Nordisk Investigational SiteBudapestHungary1132
160Novo Nordisk Investigational SiteBudapestHungary1134
161Novo Nordisk Investigational SiteDebrecenHungary4025
162Novo Nordisk Investigational SiteKaposvárHungary7400
163Novo Nordisk Investigational SiteKomaromHungary2900
164Novo Nordisk Investigational SiteSzegedHungaryH-6725
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166Novo Nordisk Investigational SiteZalaegerszegHungary8900
167Novo Nordisk Investigational SiteGdanskPoland80-858
168Novo Nordisk Investigational SiteGdyniaPoland81-338
169Novo Nordisk Investigational SiteKatowicePoland40-081
170Novo Nordisk Investigational SiteLodzPoland90-132
171Novo Nordisk Investigational SiteLodzPoland91-473
172Novo Nordisk Investigational SiteLublinPoland20-081
173Novo Nordisk Investigational SitePoznanPoland60-834
174Novo Nordisk Investigational SitePulawyPoland24-100
175Novo Nordisk Investigational SiteStaszowPoland28-200
176Novo Nordisk Investigational SiteSwidnikPoland21-040
177Novo Nordisk Investigational SiteWroclawPoland52-416
178Novo Nordisk Investigational SiteZabrzePoland41-800
179Novo Nordisk Investigational SiteBayamonPuerto Rico00961
180Novo Nordisk Investigational SiteManatiPuerto Rico00674
181Novo Nordisk Investigational SiteBelgradeSerbia11000
182Novo Nordisk Investigational SiteBelgradeSerbia11080
183Novo Nordisk Investigational SiteKragujevacSerbia34000
184Novo Nordisk Investigational SiteNovi SadSerbia21000
185Novo Nordisk Investigational SiteZajecarSerbia19000
186Novo Nordisk Investigational SiteAdanaTurkey01000
187Novo Nordisk Investigational SiteAdanaTurkey01250
188Novo Nordisk Investigational SiteAnkaraTurkey06100
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191Novo Nordisk Investigational SiteHatayTurkey31060
192Novo Nordisk Investigational SiteIstanbulTurkey34303
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194Novo Nordisk Investigational SiteIstanbulTurkey34390
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196Novo Nordisk Investigational SiteIstanbulTurkey34722
197Novo Nordisk Investigational SiteIstanbulTurkey34760
198Novo Nordisk Investigational SiteIstanbulTurkey34899
199Novo Nordisk Investigational SiteIzmirTurkey35340
200Novo Nordisk Investigational SiteKayseriTurkey38039

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:
NCT04760626
Other Study ID Numbers:
  • NN1436-4481
  • U1111-1247-5279
  • 2020-000476-38
First Posted:
Feb 18, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 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 Oct 15, 2021