ArticleDiabetes, obesity & metabolism2023
Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes.
Article in Diabetes, obesity & metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
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
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
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.
Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen
Effects of Different Insulin Icodec Initiation Strategies and a Day-4 Supplemental Dosing Decision on Early Fasting Blood Glucose Target Attainment in Type 2 Diabetes: A Multicenter, Randomized, Open-Label, 3x2 Factorial Trial
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Efficacy and safety of once-weekly basal insulin analogs versus daily basal insulin analogs in adults with type 2 diabetes: a systematic review and meta-analysis.Current diabetes reports · 2026Pooled it
- Efficacy and safety of once-weekly insulin versus once-daily insulin in patients with type 1 and type 2 diabetes mellitus: an updated meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2024Pooled it
- Simplified Switching to Once-Weekly Insulin Icodec Without an Initial One-Time Additional Dose Versus Once-Daily Insulin Glargine U100 in Basal Insulin-Treated Type 2 Diabetes (ONWARDS 10): A Randomised Controlled Trial.Diabetes, obesity & metabolism · 2026Trial
- Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8).Diabetes, obesity & metabolism · 2026Trial
- Efficacy and hypoglycaemia outcomes of once-weekly insulin icodec versus once-daily basal insulin comparators across baseline HbA1c, BMI and duration of type 2 diabetes subgroups: A post hoc analysis of ONWARDS 1-5.Diabetes, obesity & metabolism · 2026Trial
- Efficacy and Hypoglycemia Profile of Once-weekly Insulin Icodec vs Once-daily Comparators Across Demographic Subgroups.The Journal of clinical endocrinology and metabolism · 2025Trial
- Adherence to app-based dose guidance for once-weekly insulin icodec in insulin-naive individuals with type 2 diabetes: Post hoc analysis of ONWARDS 5.Diabetes, obesity & metabolism · 2025Trial
- The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5.Diabetologia · 2025Trial
- Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant-level analysis of the ONWARDS 1-5 trials.Diabetes, obesity & metabolism · 2025Trial
- Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus.Clinical drug investigation · 2024 · on this mapTrial
- Trial
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- Type 2 diabetes mellitus.Nature reviews. Disease primers · 2026Review
- Preferences for basal insulin treatments in adults with type 2 diabetes: A discrete choice experiment in France and Spain.Diabetes, obesity & metabolism · 2026Article
- Once-weekly insulin icodec versus once-daily insulin degludec for type 2 diabetes in China: A cost-utility and budget impact analysis.Diabetes, obesity & metabolism · 2026Article
- Glycemic efficacy of insulin icodec and risk factors for hypoglycemia in patients with type 2 diabetes mellitus: a real-world study.Frontiers in physiology · 2026Article
- Quantifying Patient Preferences for Basal Insulin Treatments in Adults Living with Type 2 Diabetes: A Discrete Choice Experiment in Canada, Spain, France, and Japan.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Review
- Emerging Insulin Analogues: A Glimpse into How Insulin Analogues May Look in the near Future.Pharmaceutics · 2025Review
- Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 5 countries.
Funding
Abstract
aimTo describe the phase 3a ONWARDS clinical development programme investigating insulin icodec (icodec), a once-weekly basal insulin, including the design and rationale for each of the ONWARDS 1-6 trials. MATERIALS AND
methodsSix randomized controlled trials have been initiated in adults with type 2 diabetes (T2D) (insulin-naive: ONWARDS 1, 3 and 5; previously insulin-treated: ONWARDS 2 and 4) and type 1 diabetes (T1D) (ONWARDS 6). Each trial will investigate icodec use in a unique clinical scenario, with consideration of long-term safety and varied comparator treatments (insulin glargine U100 or U300 or insulin degludec). ONWARDS 5 will incorporate real-world elements and a digital dose titration solution to guide icodec dosing. The primary objective for each of the trials is to compare the change in HbA1c from baseline to week 26 or week 52 between icodec and comparator arms. Secondary objectives include investigating other glycaemic control and safety parameters, such as fasting glucose, time in glycaemic range and hypoglycaemia. Patient-reported outcomes will assess treatment satisfaction.
conclusionsThe ONWARDS 1-6 trials will evaluate the efficacy and safety of once-weekly icodec compared with currently available daily basal insulin analogues in T2D and T1D. These trials will generate comprehensive evidence of icodec use in diverse populations across the spectrum of diabetes progression and treatment experience.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.