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

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00873639

Enrollment

417

Registered

2009-04-01

Start date

2009-04-30

Completion date

2009-11-30

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

DRUGinsulin aspart

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

DRUGinsulin detemir

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	at 24 weeks from baseline

Secondary

Measure	Time frame
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%	at 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)	at 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)	at 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections	at 12 weeks and 24 weeks of treatment
Change in body weight	at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events	at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)	at 12 weeks and 24 weeks of treatment

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026