Health Condition 1: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: Icodec: once weekly icodec subcutaneous Injection with Insulin Aspart.
59 weeks, consisting of a 2-week screening period, followed by an initial 26-week randomised treatment period, a
Sponsors
Novo Nordisk ASNovo All
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 forthe trial. 2. Male or female aged >=18 years at the time of signing informed consent. 3. Diagnosed with type 1 diabetes mellitus >= 1 year prior to the day of screening. 4. Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) >= 1year prior to the day of screening. 5. HbA1c <10% at screening visit measured by central laboratory.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to trial products or related products. 2. Previous participation in this trial. Participation is defined as signed informed consent. 3. 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). 4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screeninga. 5. Any disorder, except for conditions associated with T1D which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol.Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, orcorticosteroids). 7. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. 8. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. 9. Planned coronary, carotid or peripheral artery revascularisation. 10. Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of 11. Impaired liver function, defined as Alanine Aminotransferase (ALT) >=2.5 times or Bilirubin >1.5 times upper normal limit at screening measured by central laboratory. 12. Known hypoglycaemic unawareness as indicated by the investigator according to Clarkeâ??s questionnaire question 8.17 13. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 14. Inadequately treated blood pressure defined as systolic >=180 mmHg or diastolic >=110 mmHg at screening.15. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 16. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening. 17. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1cTimepoint: From baseline (week 0) to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfactionFrom baseline (week 0) to week 26Score 0-36 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatmentTimepoint: From baseline week 0 (V2) to week 26 (V28);Change in fasting plasma glucose (FPG)Timepoint: From baseline week 0 (V2) to week 26 (V28);Change in HbA1c From baseline (week 0) to week 52%-pointTimepoint: From baseline week 0 (V2) to week 52 (V54);Number of clinically significant hypoglycaemic episodes (level 2)(less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)Timepoint: From baseline week 0 (V2) to week 26 (V28);Time in range 3.9-10.0 mmol/L (70-180 mg/dL)Timepoint: From week 22 to week 26 % of readings | — |
Countries
Austria, Canada, Germany, India, Italy, Japan, Netherlands, Russian Federation, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Ltd
Outcome results
None listed