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A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

NCT02034513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2019-01-02

Study results available
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Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Conditions

Interventions

DRUG

insulin degludec

Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

DRUG

insulin glargine

Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

DRUG

insulin aspart

Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-05
Primary Completion
2016-01-11
Completion
2016-01-11

Countries

  • United States
  • Poland
  • Puerto Rico

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 NCT02034513 on ClinicalTrials.gov