Medical University of Graz
Graz, 8010, Austria
NCT Number: NCT06288412
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Graz, 8010, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive insulin icodec subcutaneous (s.c.) once weekly.
Participants will receive insulin degludec s.c. once daily.
Time frame: 0-24 hours after start of exercise at Day 38
Measured in percentage of readings.
Time frame: 0-24 hours after start of exercise at Day 38
Measured in percentage of readings.
Time frame: 0-24 hours after start of exercise at Day 38
Measured in percentage of readings.
Time frame: 0-24 hours after start of exercise at Day 38
Measured in percentage of readings.
Time frame: 0-40 minutes after start of exercise at Day 38
Measured as number of episodes.
Time frame: 0-40 minutes after start of exercise at Day 38
Measured in gram (g).
Time frame: 0-90 minutes before start of exercise at Day 38
Measured in g.
Time frame: 0-140 minutes after start of exercise at Day 38
Measured in g.
Time frame: 0-24 hours after start of exercise at Day 38
Measured as number of episodes.
Time frame: 43-67 hours after dosing at Day 29
Measured as number of episodes.
Time frame: 0-18 hours after start of fasting at Day 44
Measured in percentage of readings.
Time frame: 0-18 hours after start of fasting at Day 44
Measured in percentage of readings.
Time frame: 0-18 hours after start of fasting at Day 44
Measured in percentage of readings.
Time frame: 0-18 hours after start of fasting at Day 44
Measured in percentage of readings.
Time frame: 0-18 hours after start of fasting at Day 44
Measured as number of episodes.
Time frame: 0-18 hours after start of fasting at Day 44
Measured in g.
Time frame: 0-18 hours after start of fasting at Day 44
Measured as number of episodes.
Time frame: 26-44 hours after dosing at Day 29
Measured as number of episodes.
Novo Nordisk A/S
Industry
Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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