Clinical Trial Details

Overview

Research Study Summary

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

Purpose

To confirm the effect of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec using a non-inferiority approach in children and adolescents with type 1 diabetes.

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CW ID: 216183
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
1 to 18 Years
Overall Status
Recruiting
Lead Sponsor
NovoNordisk
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Diagnosed with type 1 diabetes mellitus
  • Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
  • HbA1c ≤ 9.5% (80 mmol/mol)
Exclusion Criteria:
  • More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit
  • 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

Contact

Danielle Henson
University of South Florida -Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: 813-396-9574

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