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 - Trial NCT06288412
Access comprehensive clinical trial information for NCT06288412 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novo Nordisk A/S and is currently Not yet recruiting. The study focuses on Diabetes Mellitus, Type 2. Target enrollment is 30 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Novo Nordisk A/S
Timeline & Enrollment
Phase 1
Feb 26, 2024
Nov 04, 2024
Primary Outcome
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)
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. 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06288412
Non-Device Trial