Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin NPH; Drug: human soluble insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707134

ANA/DCD/050

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Enrollment: 753 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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753 participants in 2 patient groups

insulin aspart

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin NPH

human insulin

Active Comparator group

Treatment:

Drug: human soluble insulin

Drug: insulin NPH