MedTrace Logo

Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

NCT01831765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1290

Last updated 2019-06-12

Study results available
· View outcomes & findings →

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Conditions

Interventions

DRUG

Faster-acting insulin aspart

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.

DRUG

insulin detemir

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.

DRUG

insulin aspart

Injected subcutaneously (s.c., under the skin), dose individually adjusted.

DRUG

Faster-acting insulin aspart

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-26
Primary Completion
2015-05-12
Completion
2015-06-11

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Poland
  • United Kingdom

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 NCT01831765 on ClinicalTrials.gov