NCT07160816
Recruiting
Not Applicable
A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes
InterventionsInsulin icodec
DrugsInsulin icodec
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 245
- Locations
- 82
- Primary Endpoint
- Change in glycated haemoglobin (HbA1c)
Overview
Brief Summary
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to the protocol).
- •The decision to initiate treatment with commercially available insulin icodec has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
- •Male or female, age greater than or equal to (≥) 18 years at the time of signing informed consent.
- •Diagnosed with T1D ≥ 1 year before signing informed consent.
- •Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent.
- •Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
- •Treatment naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).
Exclusion Criteria
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Treatment with any investigational drug within 30 days prior to enrolment into the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Arms & Interventions
Insulin icodec
Participants with T1D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
Intervention: Insulin icodec (Drug)
Outcomes
Primary Outcomes
Change in glycated haemoglobin (HbA1c)
Time Frame: Baseline (week 0), week 26
Measured as percentage (%) point of HbA1c.
Secondary Outcomes
- Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score(Baseline (week 0), end of study (week 22-30))
- Change in Adelphi Adherence Questionnaire (ADAQ) score(Baseline (week 0), end of study (week 22-30))
- Number of self-reported overall severe hypoglycaemia(From baseline (week 0) to end of study (week 22-30))
- Clinical success as perceived by the physician(From baseline (week 0) to end of study (week 22-30))
Investigators
Study Sites (82)
Loading locations...
Similar Trials
Completed
Phase 3
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT05813912Novo Nordisk A/S148
Completed
Phase 3
A Research Study to See How Switching from a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults with Type 2 Diabetes2023-506084-34-00Novo Nordisk A/S145
Completed
Not Applicable
Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With ExenatideDiabetes Mellitus Type 2NCT00569907HealthPartners Institute18
Completed
Phase 1
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)HypertensionNCT00871871Merck Sharp & Dohme LLC64
Completed
Not Applicable
ACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)?Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT01460446Hoffmann-La Roche218