A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Dai… (NCT04760626) | Clinical Trial Compass
CompletedPhase 3
A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
United States, Bulgaria, Canada1,085 participantsStarted 2021-03-01
Plain-language summary
This study compares insulin icodec to different daily insulins in people with type 2 diabetes.
The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.
The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.
Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.
The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Who can participate
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 trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female.
* Age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
* HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
* Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectab…
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.
1Since this trial compared a once-weekly insulin called icodec to daily insulins for people with type 2 diabetes who are just starting insulin, could it be an option worth exploring for me given that a weekly injection might be easier to manage than daily ones?
2This was a Phase 3 trial that has already completed — does that mean there's enough safety and effectiveness data on insulin icodec for my doctor to feel confident discussing it as a realistic option for me?
3The trial used something called the DoseGuide app alongside the weekly insulin — is that kind of digital support tool something my doctor thinks would actually help me manage dosing safely, and would I have access to it?
4The main thing this study measured was change in HbA1c — based on what's known from this trial, how does the blood sugar control from once-weekly icodec compare to the daily insulins I might otherwise be prescribed?
5Before considering a newer weekly insulin like the one in this trial, should I try a standard daily insulin regimen first, or does my current situation make it reasonable to discuss the weekly option right away?
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.