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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT05813912 (opens ClinicalTrials.gov in a new tab)Other idNN1436-4910Other id2022-002847-24Other idU1111-1281-4752
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
148 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
5 countries

Czechia, Malaysia, Poland, Serbia, Thailand

Start
22 Sept 2023
Primary completion
14 Apr 2025
Completion
16 May 2025
First posted
14 Apr 2023
Last update posted
3 Jun 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    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

    NCT05813912

    22 Sept 2023 to 16 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Interventions

  • Insulin IcodecDrug
  • SemaglutideDrug

Arms1

  • Experimental

    Insulin Icodec + Semaglutide

    Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame · Baseline (Week 26), Week 52

    Registry description

    Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.

Secondary outcomes(8)

  1. Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles

    Time frame · Baseline (Week 26), Week 52

    Registry description

    Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.

  2. Change in Mean Post-prandial Glucose Increment (Over All Meals)

    Time frame · Baseline (Week 26), Week 52

    Registry description

    Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame · Baseline (Week 26), Week 52

    Registry description

    Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.

  4. Number of Severe Hypoglycaemic Episodes (Level 3)

    Time frame · From baseline (week 26) to week 57

    Registry description

    Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).

  5. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter)

    Time frame · From baseline (week 26) to week 57

    Registry description

    Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).

  6. 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)

    Time frame · From baseline (week 26) to week 57

    Registry description

    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) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).

  7. Change in Body Weight

    Time frame · Baseline (Week 26), Week 52

    Registry description

    Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).

  8. Relative Change in Weekly Insulin Icodec Dose

    Time frame · From week 25 to week 52

    Registry description

    Relative change in weekly insulin icodec dose from week 25 to week 52 is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (Week 26), Week 52

Change in Glycated Haemoglobin (HbA1c)

GroupValue (Percentage (%) of HbA1c)Spread
Insulin Icodec + Semaglutide-1.230.86
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Week 26), Week 52

Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles

GroupValue (millimoles per liter (mmol/L))Spread
Insulin Icodec + Semaglutide-1.692.42
Secondary outcomeMean· Baseline (Week 26), Week 52

Change in Mean Post-prandial Glucose Increment (Over All Meals)

GroupValue (mmol/L)Spread
Insulin Icodec + Semaglutide-1.272.17
Secondary outcomeMean· Baseline (Week 26), Week 52

Change in Fasting Plasma Glucose (FPG)

GroupValue (mmol/L)Spread
Insulin Icodec + Semaglutide-1.292.24
Secondary outcomeNumber· From baseline (week 26) to week 57

Number of Severe Hypoglycaemic Episodes (Level 3)

GroupValue (Episodes)
Insulin Icodec + Semaglutide0
Secondary outcomeNumber· From baseline (week 26) to week 57

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter)

GroupValue (Episodes)
Insulin Icodec + Semaglutide13
Secondary outcomeNumber· From baseline (week 26) to week 57

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)

GroupValue (Episodes)
Insulin Icodec + Semaglutide13
Secondary outcomeMean· Baseline (Week 26), Week 52

Change in Body Weight

GroupValue (Kilograms (Kg))Spread
Insulin Icodec + Semaglutide-3.853.98

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Icodec: Run-in PeriodParticipants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization.1 / 1487 / 14814 / 148
Insulin Icodec + Semaglutide: Treatment PeriodParticipants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.0 / 943 / 9450 / 94

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

6 results

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 et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42387310PMC13449048DOI 10.1111/dom.71049PUB-42387310

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days prior to the day of screening * HbA1c from 7.5%-10.5% (58-91 millimoles per mole \[mmol/mol\]) (both inclusive) * Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) \>= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses \>= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs) Exclusion Criteria: * Presence or history of pancreatitis (acute or chronic) within 180 days before screening * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening * Planned coronary, carotid or peripheral artery revascularization * 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 initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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