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Insulin

Insulin icodec for Type 2 Diabetes (ONWARDS 4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 24 (v26) to week 26 (v28)
Awards & highlights

ONWARDS 4 Trial Summary

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)

Eligible Conditions
  • Type 2 Diabetes

ONWARDS 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 24 (v26) to week 26 (v28)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 24 (v26) to week 26 (v28) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycated haemoglobin (HbA1c)
Secondary outcome measures
Change in body weight
Change in fasting plasma glucose (FPG)
Mean weekly insulin dose
+6 more

Side effects data

From 2020 Phase 2 trial • 247 Patients • NCT03751657
11%
Headache
8%
Nasopharyngitis
6%
Upper respiratory tract infection
1%
Lower limb fracture
1%
Metrorrhagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin 287
Insulin Glargine

ONWARDS 4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: insulin icodec + insulin aspartExperimental Treatment2 Interventions
Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart
Group II: Insulin glargine + insulin aspartActive Control2 Interventions
Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin icodec
2021
Completed Phase 3
~4140
Insulin aspart
2011
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,486 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,538 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880850.
~149 spots leftby Apr 2025
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