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Diabetes Mellitus, Type 2Phase 1NCT06288412

A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting

A Phase 1 study testing Insulin icodec and Insulin degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec and Insulin degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustria
Study dates
26 Feb 2024to 14 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female.
  • Age 18-75 years (both inclusive) at the time of signing the informed consent.
  • Body mass index between 18.0 and 38.0 kilogram per meter^2 (kg/m^2) (both inclusive).
  • Glycated hemoglobin (HbA1c) less than or equal to (<=) 9 percent (75 millimoles per mole [mmol/mol]) at screening.
  • Treated with basal insulin with or without any of the following anti-diabetic drugs/regimens with stable doses >= 90 days prior to the day of screening:
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  • Metformin,
  • Dipeptidyl peptidase 4 (DPP-4) inhibitors,
  • Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors
  • Oral combination products (for the allowed individual oral antidiabetic drugs), Injectable and oral glucagon-like peptide 1 (GLP-1) Receptor Agonists.
  • Physically active >= 300 metabolic equivalent of task (MET) minutes/week as determined by an International Physical Activity Questionnaire (IPAQ) at screening.
  • Mass-specific oxygen volume (VO2) peak greater than (>) 25 milliliters per kilogram per minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test at screening.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days prior to the day of screening.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz

    Graz, 8010

Other trials in Austria

About this study

Official title: Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Being tested
Insulin icodec, Insulin degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Participants will receive insulin icodec subcutaneous (s.c.) once weekly.

  • Insulin degludecDrug

    Participants will receive insulin degludec s.c. once daily.

Study groups in NCT06288412
Study groupRoleWhat they receive
Insulin icodecExperimentalParticipants will receive subcutaneous (s.c.) injections of insulin degludec once daily in the run-in period and insulin icodec once weekly in the treatment period.
Receives: Drug: Insulin icodec; Drug: Insulin degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe)

    Measured in percentage of readings.

    Measured: 0-24 hours after start of exercise at Day 38

Secondary outcomes (17)

  1. Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe)

    Measured in percentage of readings.

    Measured: 0-24 hours after start of exercise at Day 38

  2. Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe)

    Measured in percentage of readings.

    Measured: 0-24 hours after start of exercise at Day 38

  3. Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe)

    Measured in percentage of readings.

    Measured: 0-24 hours after start of exercise at Day 38

  4. Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe)

    Measured as number of episodes.

    Measured: 0-40 minutes after start of exercise at Day 38

  5. Amount of carbohydrate intake during exercise (CHOexe)

    Measured in gram (g).

    Measured: 0-40 minutes after start of exercise at Day 38

  6. Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe)

    Measured in g.

    Measured: 0-90 minutes before start of exercise at Day 38

  7. Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe)

    Measured in g.

    Measured: 0-140 minutes after start of exercise at Day 38

  8. Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe)

    Measured as number of episodes.

    Measured: 0-24 hours after start of exercise at Day 38

  9. Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref)

    Measured as number of episodes.

    Measured: 43-67 hours after dosing at Day 29

  10. Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast)

    Measured in percentage of readings.

    Measured: 0-18 hours after start of fasting at Day 44

  11. Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast)

    Measured in percentage of readings.

    Measured: 0-18 hours after start of fasting at Day 44

  12. Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast)

    Measured in percentage of readings.

    Measured: 0-18 hours after start of fasting at Day 44

  13. Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast)

    Measured in percentage of readings.

    Measured: 0-18 hours after start of fasting at Day 44

  14. Number of clinically significant hypoglycaemic episodes during fasting (Hypofast)

    Measured as number of episodes.

    Measured: 0-18 hours after start of fasting at Day 44

  15. Amount of carbohydrate administered intravenously during fasting (CHOfast)

    Measured in g.

    Measured: 0-18 hours after start of fasting at Day 44

  16. Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast)

    Measured as number of episodes.

    Measured: 0-18 hours after start of fasting at Day 44

  17. Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref)

    Measured as number of episodes.

    Measured: 26-44 hours after dosing at Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start26 Feb 2024
  3. Primary completion10 Mar 2025
  4. Study completion14 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288412
Sponsor's protocol ID
NN1436-7615
Other IDs
U1111-1285-1665, 2023-505012-38, 2023
Status last verified
Jun 2026
First submitted
23 Feb 2024
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Pieber TR, Bajaj HS, Fluhr G, Klein KR, Pagliaro Rocha TM, Sourij H, Svehlikova E, Udupa K, Watt SK, Willerslev-Olsen M, Ribel-Madsen R. Exercise or Fasting in Individuals With Type 2 Diabetes Receiving Once-Weekly Basal Insulin Icodec. Diabetes Obes Metab. 2026 Jul 1. doi: 10.1111/dom.71050. Online ahead of print.

    PubMed 42387301

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin icodec and Insulin degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe) (time frame: 0-24 hours after start of exercise at Day 38). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06288412, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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