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).

Strojek K, Liebl A, Mumbaikar NN, Søgaard SB, Kehlet Watt S, Philis-Tsimikas A

Diabetes, obesity & metabolism1 Jul 2026Cited by 1 (Europe PMC)

PMID42387310PMCIDPMC13449048DOI10.1111/dom.71049PepBankPUB-42387310

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with type 2 diabetes on once-weekly icodec, adding semaglutide lowered mean HbA1c by an estimated 1.23 percentage points from week 26 to week 52.
In plain wordsIn adults with type 2 diabetes on weekly insulin icodec, adding semaglutide lowered HbA1c over 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from week 26 to week 52
Study
n = 94
Comparator
Baseline (week 26, on icodec)
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−1.23 %-points
week 26 to week 52
Source sentences
Summary
From baseline to Week 52, mean HbA1c decreased from 7.88% (observed) to 6.66% (estimated), with an estimated mean change of -1.23%-points (95% confidence interval: -1.39, -1.07%-points; p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731001
02HumanNon-randomized trialEfficacy outcome
In adults with type 2 diabetes on once-weekly icodec, adding semaglutide significantly lowered the 7-point self-measured blood glucose profile.
In plain wordsIn adults with type 2 diabetes on weekly insulin icodec, adding semaglutide lowered daily blood sugar readings.
Peptide
Semaglutide
Outcome
Decrease7-point self-measured blood glucose profile
Study
n = 94
Comparator
Baseline (week 26, on icodec)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
7-point SMBG change
−1.72 mmol/L
week 52 vs baseline
Source sentences
Summary
Statistically significant changes from baseline to Week 52 were observed in 7-point self-measured blood glucose profile (-1.72 mmol/L), postprandial glucose increment (-1.31 mmol/L) and body weight (-3.85 kg) (all p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731002
03HumanNon-randomized trialEfficacy outcome
In adults with type 2 diabetes on once-weekly icodec, adding semaglutide significantly lowered the postprandial glucose increment.
In plain wordsIn adults with type 2 diabetes on weekly insulin icodec, adding semaglutide reduced the blood sugar rise after meals.
Peptide
Semaglutide
Outcome
DecreasePostprandial glucose increment
Study
n = 94
Comparator
Baseline (week 26, on icodec)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
Postprandial glucose increment change
−1.31 mmol/L
week 52 vs baseline
Source sentences
Summary
Statistically significant changes from baseline to Week 52 were observed in 7-point self-measured blood glucose profile (-1.72 mmol/L), postprandial glucose increment (-1.31 mmol/L) and body weight (-3.85 kg) (all p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731003
04HumanNon-randomized trialEfficacy outcome
In adults with type 2 diabetes on once-weekly icodec, adding semaglutide significantly reduced body weight.
In plain wordsIn adults with type 2 diabetes on weekly insulin icodec, adding semaglutide led to weight loss.
Peptide
Semaglutide
Outcome
DecreaseBody weight
Study
n = 94
Comparator
Baseline (week 26, on icodec)
Outcome group
Body weight · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
Body weight change
−3.85 kg
week 52 vs baseline
Source sentences
Summary
Statistically significant changes from baseline to Week 52 were observed in 7-point self-measured blood glucose profile (-1.72 mmol/L), postprandial glucose increment (-1.31 mmol/L) and body weight (-3.85 kg) (all p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731004
05HumanNon-randomized trialEfficacy outcome
In adults with type 2 diabetes who added semaglutide, mean weekly icodec dose fell by 24% from week 25 to week 52.
In plain wordsIn adults with type 2 diabetes who added semaglutide, the weekly icodec insulin dose was reduced by 24%.
Peptide
Semaglutide
Outcome
DecreaseWeekly icodec dose change
Study
n = 94
Comparator
Week 25 icodec dose
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
Relative decrease in icodec dose
24%
week 25 to week 52
Participants with icodec dose reduced by 20%
69.1%
week 26
Source sentences
Summary
The relative decrease in mean weekly icodec dose from Week 25 to Week 52 was 24% (69.1% of participants had their icodec dose reduced by 20% at Week 26, per protocol).
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731005
06HumanNon-randomized trialSafety outcome
In adults with type 2 diabetes who added semaglutide to icodec, combined clinically significant or severe hypoglycaemia occurred at 0.24 episodes per person-year of exposure.
In plain wordsIn adults with type 2 diabetes who added semaglutide to weekly insulin, serious low blood sugar was rare, at 0.24 episodes per person-year.
Peptide
Semaglutide
Outcome
Not applicableClinically significant or severe hypoglycaemia
Study
n = 94
Outcome group
Adverse events · Metabolic and weight
Studied dose
up to 1.0 mg · 26 weeksAs given in this study (human).
Measurements
Hypoglycaemia rate
0.24 episodes per person-year
baseline to week 57
Source sentences
Summary
From baseline to Week 57 (end of trial), the rate of combined clinically significant or severe hypoglycaemia was 0.24 episodes per person-year of exposure.
2 context sentences(design, population, supporting numbers)
Summary · context
ONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period.
Summary · context
Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist.
Report a problemFND-4238731006

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05813912

A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Novo Nordisk A/Sn = 14822 Sept 2023 to 16 May 2025

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 3 Jun 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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