Health Condition 1: null- Type 1 diabetes in children and adolescents Health Condition 2: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: Faster-acting insulin aspart
: ||Pre-meal arm: subcutaneous injection 0-2 minutes before each meal, titrated based on pre-defined algorithm or carbohydrate counts, 26 weeks
||Post-meal arm: subcutaneous injection, 20 minutes after the start of the meal, titrated based on pre-defined algorithm or carbohydrate counts, 26 weeks.
Control Intervention1: Insulin aspart
: subc
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: "Informed consent and child assent, as age-appropriate, 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. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according to local requirements Male or female, 1 Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) Ongoing daily treatment with a basal-bolus insulin regimen using a basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit Ability and willingness to take at least 3 daily meal-time related bolus insulin injections throughout the trial (Subject and LAR(s) should be evaluated as a unit) Total daily dose of insulin HbA1c Willingness to NOT use real time CGM during the trial"
Exclusion criteria
Exclusion criteria: Known or suspected hypersensitivity to trial products 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) For EU only: Adequate contraceptive measures are implants, injectable, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner. For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives. Participation in another clinical trial within 28 days before the screening visit Note: Clinical trials do not include non-interventional studies Anticipated initiation or change in concomitant medication in excess of 14 days known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) Any condition, which, in the opinion of the Investigator, might jeopardise the Subjects safety or compliance with the protocol (Subject and LAR(s) should be evaluated as a unit) Diagnosis of malignant neoplasms within the last five years prior to the screening visit Known hypoglycaemic unawareness or recurrent severe hypoglycaemic episodes as judged by the Investigator More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1cTimepoint: 26 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Supportive secondary efficacy endpoints a.Change from baseline in 8-point self-measured plasma glucose (SMPG) profile (8-point profile) b.Change from baseline in fasting plasma glucose (FPG) c.Change from baseline in 1,5-anhydroglucitol d.Percentage of Subjects reaching HbA1c target (HbA1c7.5 %) according to ISPAD guidelinesTimepoint: 26 weeks after randomisation ;2. Supportive secondary efficacy endpoints a.Percentage of Subjects reaching HbA1c target (HbA1c7.5 %) according to ISPAD guidelines, without severe hypoglycaemia b.Insulin dose (Units/day and Units/kg/day; total basal, total bolus and individual meal insulin dose)Timepoint: 26 weeks after randomisation;3. Supportive secondary safety endpoints a.Number of treatment emergent hypoglycaemic episodes b.Number of treatment emergent adverse events (AEs) c.Number of treatment emergent injection site reactions d.Change from baseline in clinical evaluations (physical examination and vital signs) Timepoint: 26 weeks after randomisation ;4. Supportive secondary safety endpoints a.Change from baseline in body weight, height, body mass index and SD score of body weight and body mass index (z score) b.Change from baseline in laboratory assessments (haematology, biochemistry and lipid profile) c.Change from baseline in anti-insulin aspart (specific and cross-reacting with human insulin and total of these) antibody development Timepoint: 26 weeks after randomisation | — |
Countries
Bulgaria, Czech Republic, Estonia, Finland, Germany, India, Israel, Italy, Japan, Latvia, Lithuania, Poland, Russian Federation, Serbia, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed