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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00873639

INS-3721

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

417 participants in 1 patient group

A

Treatment:

Drug: insulin detemir

Drug: insulin aspart