Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Type-1 Diabetes in Adults
Conditions
Interventions
Intervention1: Faster aspart insulin
: Dose: Subjects will be switched from marketed product to trial products by unit-to-unit method
Frequency: 3 times a day
Route of administration: Subcutaneously
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
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 >= 18 years (for Japan and Taiwan: age >=20 years) at the time of signing informed consent Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) >=12 months prior to screening "Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1)" Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory Body Mass Index "Ability and willingness to adhere to the protocol including performing of self-measured plasma glucose profiles and meal test" Ability and willingness to take at least three mealtime boluses a day every day during the trial "Not currently using real time continuous glucose monitoring system and/or willing not to use a real time continuous glucose monitoring system during the trial"
Exclusion criteria
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 adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)." Receipt of any investigational medicinal product within four weeks before screening (Visit 1) Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial "Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack" Subjects presently classified as being in New York Heart Association Class IV Currently planned coronary, carotid or peripheral artery revascularisation "Inadequately treated blood pressure as defined as Class 2 hypertension or higher (Systolic>=160 mmHg or diastolic >=100 mmHg)" Impaired liver function, defined as alanine aminotransferase >=2.5 times upper limit of normal "Renal impairment estimated glomerular filtration rate central laboratory" "Anticipated initiation or change in concomitant medications in excess of two weeks known to affect weight or glucose metabolism, such as weight loss/modifying (e.g. sibutramine, orlistat, thyroid hormones, corticosteroids)" "Proliferative retinopathy or maculopathy requiring acute treatment as verified by fundus photography or dilated fundoscopy performed within three months before screening (Visit 1)" "Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1)" "Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)" "Diagnosis of malignant neoplasms within the last five years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas) prior to screening (Visit 1)" "Any condition which, in the opinion of the Investigator might jeopardise subjectâ??s safety or compliance with the protocol" Anticipated initiation in use of real time continuous glucose monitoring system during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c after 26 weeks of treatment Timepoint: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 1,5-anhydroglucitol after 26 weeks of treatment Timepoint: 26 weeks;Change from baseline in 1-hour post prandial glucose increment after 26 weeks of treatment (meal test) Timepoint: 26 weeks | — |
Countries
Austria, Bulgaria, Canada, Germany, India, Israel, Italy, Japan, Russian Federation, Serbia, Taiwan, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed