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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin icodec
* Drug: Insulin Glargine 100U/mL
* Drug: Insulin Degludec
* Drug: Insulin Glargine 300U/mL


Participation Criteria
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Eligibility Criteria
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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 injectable GLP-1-receptor agonists Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator. Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products. Previous participation in this trial. Participation is defined as signed informed consent. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening) Any disorder which in the investigator's opinion might jeopardise subject's safety
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin icodec with DoseGuide<br>Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration. | Drug: Insulin icodec<br>* Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.<br>|
| Active Comparator: Once daily basal insulin analogues<br>Participants randomised to basal insulin analogue injections once daily | Drug: Insulin Glargine 100U/mL<br>* Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.<br>Drug: Insulin Degludec<br>* Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.<br>Drug: Insulin Glargine 300U/mL<br>* Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycated haemoglobin) | %-point | From baseline week 0 (V2) to week 52 (V6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from baseline to treatment discontinuation or intensification | Days | From baseline week 0 (V2) to week 52 (V6) | 
| Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction | Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment. | From baseline week 0 (V2) to week 52 (V6) | 
| Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain | Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance. | At end of treatment week 52 (V6) | 
| Number of severe hypoglycaemic episodes (level 3) | Number of episodes | From baseline week 0 (V2) to week 57 (V8) | 
| Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) | Number of episodes | From baseline week 0 (V2) to week 57 (V8) | 
| Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) | Number of episodes | From baseline week 0 (V2) to week 57 (V8) |