A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes … (NCT06288412) | Clinical Trial Compass
CompletedPhase 1
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
Austria30 participantsStarted 2024-02-26
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
* 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.
Exclusion Criteria:
* 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 chi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically looked at how a new long-acting insulin behaves during exercise and prolonged fasting in people with Type 2 diabetes — given my own activity level and lifestyle, is that kind of stress-testing relevant to my situation, and what did the results suggest about low blood sugar risk during those activities?
2The trial's primary measurement was how often blood sugar dropped below a dangerously low level of 54 mg/dL in the 24 hours after exercise — does that tell us anything meaningful about how this new insulin might compare to my current or potential insulin options in terms of hypoglycemia risk?
3Since this was a Phase 1 study, which is mainly designed to understand how a drug works in the body rather than prove it's effective, how much should I read into these findings, and what would need to happen in later-phase trials before this insulin might be a real option for me?
4The trial is now completed — do you know if the results have been published or if follow-up studies are planned, and would that affect whether this new insulin could eventually be part of my treatment plan?
5Before considering any newer insulin being studied in trials like this one, should we make sure I've fully explored the long-acting insulins already approved and available, and how would we decide if one of those is a better starting point for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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)
Timeframe: 0-24 hours after start of exercise at Day 38