Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

Novo Nordisk A/S417 enrolled

Overview

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.

Study Type

OBSERVATIONAL

Enrollment

417

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin aspartDRUG

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

insulin detemirDRUG

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen Exclusion Criteria: * Subjects currently being treated with insulin aspart and insulin detemir * Subjects who were previously enrolled in this study * Subjects with a hypersensitivity to insulin aspart or to any of the excipients * Subjects with a hypersensitivity to insulin detemir or to any of the excipients * Women who are pregnant or have the intention of becoming pregnant within next 6 months

Locations (1)

Novo Nordisk Investigational Site

Bucharest, Romania

Outcomes

Primary Outcomes

Change in HbA1c

Time frame: at 24 weeks from baseline