Insulin icodec
DrugParticipants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
NCT Number: NCT04760626
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.
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Interventional
Phase 3
UMHAT - Burgas AD, Burgas, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Time frame: Baseline (week 0), week 52
Change in HbA1c from baseline (week 0) to week 52 is presented.
Time frame: From baseline (week 0) to week 52
Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.
Time frame: Baseline (week 0), week 52
Change in DTSQs in total treatment satisfaction is presented. The DTSQs questionnaire was used to assess participants treatment satisfaction which contained 8 components (DTSQs Item 1-8 : how satisfied are you with your current treatment, how often have you felt that blood sugars have been unacceptably high, how often have you felt that blood sugars have been unacceptably low, how convenient have you been finding your treatment to be recently, how flexible have you been finding your treatment to be recently, how satisfied are you with your understanding of your diabetes, would you recommend treatment to someone else with your kind of diabetes, how satisfied would you be to continue with present form of treatment). The result presented is the treatment satisfaction summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Total scores for treatment satisfaction range from 0-36 with 0 being the lowest and 36 being the highest score in total treatment satisfaction.
Time frame: At end of treatment (week 52)
Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance domain at week 52 is presented. The TRIM-D questionnaire was developed to capture the impact of diabetes treatment on patients' functioning and well-being. The questionnaire was used to measure the compliance between the treatment groups. The total TRIM-D compliance score is computed by summing across the items and then transforming to a 0-100 scale with higher score indicating better compliance.
Time frame: From baseline (week 0) to week 57
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Time frame: From baseline (week 0) to week 57
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 millimoles per liter [mmol/L] (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Time frame: From baseline (week 0) to week 57
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) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Novo Nordisk A/S
Industry
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
Acronym: ONWARDS 5
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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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