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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

NCT02670915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2019-06-05

Study results available
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Summary

This trial is conducted globally. The aim of the trial is to investigate 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.

Conditions

Interventions

DRUG

Faster-acting insulin aspart

For subcutaneous (s.c., under the skin) injection once daily.

DRUG

insulin aspart

For subcutaneous (s.c., under the skin) injection once daily.

DRUG

insulin degludec

For subcutaneous (s.c., under the skin) injection once daily.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-04
Primary Completion
2018-02-05
Completion
2018-03-03

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • Finland
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Poland
  • Puerto Rico
  • Russia
  • Serbia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670915 on ClinicalTrials.gov