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

Sponsor
Novo Nordisk A/S
Study ID
NCT06288412
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin icodec — DRUG
    Participants will receive insulin icodec subcutaneous (s.c.) once weekly.
  • Insulin degludec — DRUG
    Participants will receive insulin degludec s.c. once daily.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Jun 2026
Primary completion
Mar 10, 2025
Completion
Apr 14, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin icodec
    Participants 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.

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 ]

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