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CompletedNCT06340854Updated Aug 11, 2026Results posted

A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

A Phase 3 interventional study of Insulin icodec and Insulin glargine in Diabetes, Type 2, sponsored by Novo Nordisk A/S. Completed at 83 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
412
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

02

Conditions studied

  • Diabetes, Type 2
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 412 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.
  • HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
  • Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
  • Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).

Exclusion criteria

Exclusion Criteria:

  • Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
  • 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
412 participants (actual)

Study arms

  • Experimental
    Insulin icodec

    Participants will receive Insulin icodec subcutaneously once weekly.

    Drug: Insulin icodec · Drug: Insulin glargine

  • Active comparator
    Insulin glargine U100

    Participants will receive Insulin glargine subcutaneously once daily.

    Drug: Insulin icodec · Drug: Insulin glargine

Interventions

  • DrugInsulin icodec

    Insulin Icodec will be administered subcutaneously.

  • DrugInsulin glargine

    Insulin glargine will be administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

    Change in HbA1c from week 0 to week 26 in percentage point is presented.

    Time frame: Week 0, Week 26

Secondary outcomes

  1. Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))

    Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.

    Time frame: week -4-0, week 22-26

  2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction

    Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

    Time frame: week 0 to week 26

  3. Number of Severe Hypoglycaemic Episodes (Level 3)

    Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

    Time frame: From baseline (week 0) to week 31

  4. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

    Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented.

    Time frame: From baseline (week 0) to week 31

  5. 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)

    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) from baseline (week 0) to week 31 is presented.

    Time frame: From baseline (week 0) to week 31

  6. Time Spent < 3.0 mmol/L (54 mg/dL)

    Time spent \< 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.

    Time frame: Week 22-26

  7. Change in Time Spent > 10.0 mmol/L (180 mg/dL)

    Change in time spent \> 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.

    Time frame: Week -4-0, Week 22-26

  8. Mean Weekly Insulin Dose

    Mean weekly insulin dose from week 24 to week 26 is presented.

    Time frame: From week 24 to week 26

  9. Change in Body Weight

    Change in body weight from baseline (week 0) to (week 26) is presented.

    Time frame: Week 0, Week 26

07

Results

Posted Jul 2, 2026

Participant flow

The trial was conducted at 66 sites in 8 countries.

Participant flow — Overall Study
MilestoneInsulin IcodecInsulin Glargine
Started206206
Full analysis set206206
Safety analysis set206206
Completed206203
Not completed03
Withdrew: Withdrawal by subject03

Outcome measures

PrimaryChange in Glycated Haemoglobin (HbA1c)

Change in HbA1c from week 0 to week 26 in percentage point is presented.

Time frame:
Week 0, Week 26
Reported as:
Mean · Percentage (%) point
Change in Glycated Haemoglobin (HbA1c)
Percentage (%) pointInsulin IcodecInsulin Glargine
Change in Glycated Haemoglobin (HbA1c)-0.84 ± 0.83-0.58 ± 0.89
Statistical analysis
  • Insulin Icodec vs Insulin Glargine · ANCOVA · p = <0.0001 · Treatment difference: -0.21 · 95% CI -0.36 to -0.07
SecondaryChange in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))

Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.

Time frame:
week -4-0, week 22-26
Reported as:
Mean · Percentage (%) of time
Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))
Percentage (%) of timeInsulin IcodecInsulin Glargine
Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))19.94 ± 20.4911.04 ± 19.43
SecondaryChange in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction

Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

Time frame:
week 0 to week 26
Reported as:
Mean · Score on a scale
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction
Score on a scaleInsulin IcodecInsulin Glargine
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction3.94 ± 6.962.20 ± 5.94
SecondaryNumber of Severe Hypoglycaemic Episodes (Level 3)

Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

Time frame:
From baseline (week 0) to week 31
Reported as:
Number · Episodes
Number of Severe Hypoglycaemic Episodes (Level 3)
EpisodesInsulin IcodecInsulin Glargine
Number of Severe Hypoglycaemic Episodes (Level 3)21
SecondaryNumber of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented.

Time frame:
From baseline (week 0) to week 31
Reported as:
Number · Episodes
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
EpisodesInsulin IcodecInsulin Glargine
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)5370
SecondaryNumber of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

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) from baseline (week 0) to week 31 is presented.

Time frame:
From baseline (week 0) to week 31
Reported as:
Number · Episodes
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)
EpisodesInsulin IcodecInsulin Glargine
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)5571
SecondaryTime Spent < 3.0 mmol/L (54 mg/dL)

Time spent \< 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.

Time frame:
Week 22-26
Reported as:
Mean · % of time
Time Spent < 3.0 mmol/L (54 mg/dL)
% of timeInsulin IcodecInsulin Glargine
Time Spent < 3.0 mmol/L (54 mg/dL)0.27 ± 0.480.23 ± 0.54
SecondaryChange in Time Spent > 10.0 mmol/L (180 mg/dL)

Change in time spent \> 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.

Time frame:
Week -4-0, Week 22-26
Reported as:
Mean · % of time
Change in Time Spent > 10.0 mmol/L (180 mg/dL)
% of timeInsulin IcodecInsulin Glargine
Change in Time Spent > 10.0 mmol/L (180 mg/dL)-20.54 ± 21.10-11.19 ± 19.94
SecondaryMean Weekly Insulin Dose

Mean weekly insulin dose from week 24 to week 26 is presented.

Time frame:
From week 24 to week 26
Reported as:
Geometric mean · Units of insulin/week
Mean Weekly Insulin Dose
Units of insulin/weekInsulin IcodecInsulin Glargine
Mean Weekly Insulin Dose278.45 ± 71.44270.19 ± 62.45
SecondaryChange in Body Weight

Change in body weight from baseline (week 0) to (week 26) is presented.

Time frame:
Week 0, Week 26
Reported as:
Mean · Kilogram (kg)
Change in Body Weight
Kilogram (kg)Insulin IcodecInsulin Glargine
Change in Body Weight2.04 ± 2.870.55 ± 3.16

Adverse events

Collected over From week 1 to week 31. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Insulin Icodec0/206 (0%)16/206 (7.8%)42/206 (20.4%)
Insulin Glargine0/206 (0%)12/206 (5.8%)30/206 (14.6%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventInsulin IcodecInsulin Glargine
Acute kidney injuryRenal and urinary disorders0/2062/206
PneumoniaInfections and infestations2/2062/206
Acquired oesophageal webGastrointestinal disorders0/2061/206
Alanine aminotransferase increasedInvestigations0/2061/206
Angina unstableCardiac disorders1/2060/206
Arthritis bacterialInfections and infestations0/2061/206
Aspartate aminotransferase increasedInvestigations0/2061/206
Atrial flutterCardiac disorders1/2060/206
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2060/206
Bronchitis bacterialInfections and infestations1/2060/206
Most frequent other events
Most frequent other events
EventInsulin IcodecInsulin Glargine
NasopharyngitisInfections and infestations28/20616/206
Diabetic retinopathyEye disorders6/20615/206
DiarrhoeaGastrointestinal disorders11/2064/206

Baseline characteristics

Full analysis set included all randomised participants.

Age, Continuous
Age, Continuous(Years)Insulin IcodecInsulin GlargineTotal
Mean62.41 ± 9.9162.52 ± 9.6562.47 ± 9.77
Sex: Female, Male
Sex: Female, Male(Participants)Insulin IcodecInsulin GlargineTotal
Female8490174
Male122116238
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Insulin IcodecInsulin GlargineTotal
Hispanic or Latino262753
Not Hispanic or Latino178175353
Unknown or Not Reported246
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Insulin IcodecInsulin GlargineTotal
American Indian or Alaska Native101
Asian6974143
Black or African American8816
White127122249
American Indian or Alaska Native, White011
Not reported112
08

Study locations

83 sites
  • Valley Research
    Fresno, California 93720, United States
  • Advanced Investigative Medicine, Inc.
    Hawthorne, California 90250, United States
  • Scripps Whittier Diabetes Inst
    La Jolla, California 92037, United States
  • Headlands Research CTR Lincoln
    Lincoln, California 95648, United States
  • Northeast Research Institute of Florida
    Fleming Island, Florida 32003, United States
  • South Broward Research LLC
    Miramar, Florida 33027, United States
  • Endo Res Solutions Inc
    Roswell, Georgia 30076, United States
  • Rocky Mountain Diab&Osteo Ctr
    Idaho Falls, Idaho 83404-7596, United States
  • Velocity Clinical_Valparaiso
    Valparaiso, Indiana 46383, United States
  • Iowa Diab & Endo Res Center
    West Des Moines, Iowa 50266, United States
  • Cotton-Oneill Diabetes and End
    Topeka, Kansas 66606-2806, United States
  • International Diabetes Center
    Minneapolis, Minnesota 55416, United States
  • Jefferson City Medical Group, PC
    Jefferson City, Missouri 65109, United States
  • Univ of Nebraska Medical CTR
    Omaha, Nebraska 68198-3020, United States
  • Palm Research Center Inc-Vegas
    Las Vegas, Nevada 89148, United States
  • Southern NH Diabetes and Endo_Nashua
    Nashua, New Hampshire 03060, United States
  • PharmQuest Life Sciences LLC
    Greensboro, North Carolina 27408, United States
  • Accellacare Wilmington
    Wilmington, North Carolina 28401, United States
  • Trial Management Associates
    Myrtle Beach, South Carolina 29572, United States
  • Amarillo Medical Specialists
    Amarillo, Texas 79124, United States
  • Velocity Clinical Res-Dallas
    Dallas, Texas 75230, United States
  • Diabetes and Thyroid Ctr of FW
    Fort Worth, Texas 76132, United States
  • Victorium Clinical Research
    Houston, Texas 77024, United States
  • PlanIt Research, PLLC
    Houston, Texas 77079, United States
  • Chrysalis Clinical Research
    St. George, Utah 84790, United States
  • Capital Clin Res Ctr,LLC
    Olympia, Washington 98502, United States
  • Rainier Clin Res Ctr Inc
    Renton, Washington 98057, United States
  • Medical Center Viva Feniks OOD
    Dobrich, 9300, Bulgaria
  • MHAT Knyaginya Klementina - Sofia EAD
    Sofia, 1233, Bulgaria
  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
    Sofia, 1431, Bulgaria
  • Medical Institute of Ministry of interior
    Sofia, 1606, Bulgaria
  • Medical Centre - Clinic Nova EOOD
    Varna, 9000, Bulgaria
  • MC Berbatov EOOD, Beli Drin
    Yambol, 8600, Bulgaria
  • InnoDiab Forschung GmbH
    Essen, 45136, Germany
  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
    Münster, 48145, Germany
  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
    Münster, 48153, Germany
  • RED-Institut für medizinische Forschung und Fortbildung GmbH
    Oldenburg in Holstein, 23758, Germany
  • Institut für Diabetesforschung Osnabrück
    Osnabrück, 49080, Germany
  • Zentrum für klinische Studien Allgäu Oberschwaben
    Wangen, 88239, Germany
  • Swasthya Diabetes Care
    Ahmedabad, Gujarat 390013, India
  • Lifecare Hospital and Research Centre
    Bangalore, Karnataka 560092, India
  • Belgaum Diabetes Centre
    Belagavi, Karnataka 590001, India
  • Manipal Hospital, Old Airport Road, Bengaluru
    Bengaluru, Karnataka 560017, India
  • Amrita Institute Of Medical Sciences & Research Centre
    Kochi, Kerala 682041, India
  • TOTALL Diabetes Hormone Institute
    Indore, Madhya Pradesh 452010, India
  • Seth GS Medical College & KEM Hospital
    Mumbai, Maharashtra 400012, India
  • Grant Medical Foundation Ruby Hall Clinic
    Pune, Maharashtra 411001, India
  • Chellaram Diabetes Institute
    Pune, Maharashtra 411021, India
  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
    Puducherry, Tamil Nadu 605006, India
  • Gandhi Hospital & Medical college
    Hyderabad, Telangana 500003, India
  • Malla Reddy Narayana Multispeciality Hospital
    Hyderabad, Telangana 500055, India
  • FS Endocrine and diabetes Center
    Saidābād, Telangana 500059, India
  • Government Institute of Medical Sciences
    Noida, Uttar Pradesh 201310, India
  • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
    Chandigarh, 160012, India
  • Christian Medical College and Hospital
    Ludhiana, 141008, India
  • Heiwadai Hospital_Internal Medicine
    Miyazaki, Miyazaki 880-0034, Japan
  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
    Shinjuku-ku, Tokyo, Tokyo 160-0023, Japan
  • Futata Tetsuhiro Clinic Meinohama_Internal medicine
    Fukuoka-shi, Fukuoka, 819-0006, Japan
  • Oyama East Clinic_Internal Medicine
    Tochigi, 323-0022, Japan
  • Noritake Clinic
    Ushiku-shi, Ibaraki, 300-1207, Japan
  • Uniwersytecki Szpital Kliniczny w Opolu
    Opole, Opole Voivodeship 45-401, Poland
  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
    Bialystok, Podlaskie Voivodeship 15-435, Poland
  • NZOZ Vita-Diabetica Malgorzata Buraczyk
    Bialystok, Podlaskie Voivodeship 15-879, Poland
  • Centrum Medyczne Pratia Gdynia
    Gdynia, Pomeranian Voivodeship 81-338, Poland
  • NZOZ Euromedica Sp. z o.o.
    Grudziądz, 86-300, Poland
  • Centrum Medyczne Pratia Katowice
    Katowice, 40-081, Poland
  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
    Warsaw, 02-507, Poland
  • Trialmed CRS
    Piotrkow Trybunalski, Łódź Voivodeship 97-300, Poland
  • Advanced Clinical Research LLC
    Bayamón, 00959, Puerto Rico
  • Manati Ctr For Clin Research
    Manati, 00674, Puerto Rico
  • Medi-Clinic Bloemfontein
    Bloemfontein, Free State 9301, South Africa
  • Hemant Makan
    Johannesburg, Gauteng 1827, South Africa
  • Centre for Diabetes
    Johannesburg, Gauteng 2198, South Africa
  • Dr Moosa's Rooms
    Lenasia, Gauteng 1827, South Africa
  • Botho ke Bontle Health Services
    Pretoria, Gauteng 0184, South Africa
  • Dr A Amod
    Durban, KwaZulu-Natal 4092, South Africa
  • Dr MB Moosa's Practice
    Durban, KwaZulu-Natal 4092, South Africa
  • Dr Mahesh Duki Research And Trial Site
    Durban, KwaZulu-Natal 4339, South Africa
  • Hospital de Basurto
    Bilbao, Vizcaya 48013, Spain
  • Hospital Clinic i Provincial
    Barcelona, 08036, Spain
  • ABS La Roca CAP Vicenç_Endocrino
    La Roca Del Vallés, 08430, Spain
  • H. Clinico Univ. Virgen de la Victoria
    Málaga, 29010, Spain
  • H.U. Quirónsalud Madrid
    Pozuelo de Alarcón, 28223, Spain
09

References and documents

Publications

  • Rosenstock J, Mathieu C, Feinberg JB, Rao P, Scavenius C, Cheng AYY. 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 Obes Metab. 2026 May 21. doi: 10.1111/dom.70813. Online ahead of print. PubMed 42168822 ↗

Study documents

  • Study protocol · Apr 2, 2024
  • Statistical analysis plan · Apr 11, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06340854
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 2, 2024
Start date
Apr 19, 2024
Primary completion
May 8, 2025
Completion
Jun 13, 2025
Results posted
Jul 2, 2026
Last update
Aug 11, 2026

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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