Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in Combination with Insulin Degludec in Children and Adolescents with Type 1 Diabetes

Phase 3

Completed

• Conditions: Health Condition 1: null- Type 1 diabetes in children and adolescentsHealth Condition 2: E10- Type 1 diabetes mellitus

• Registration Number: CTRI/2017/03/007985
• Lead Sponsor: ovo Nordisk India Private Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

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 <= age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation

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 <= 2.0 U/kg prior to the screening visit

HbA1c <= 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Ability and willingness to adhere to the protocol, including performing self-measured plasma glucose profiles (Subject and LAR(s) should be evaluated as a unit)

Willingness to NOT use real time CGM during the trial

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1cTimepoint: 26 weeks after randomisation <br/ ><br>