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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin aspart; Drug: insulin detemir

• Registration Number: NCT00873639
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study Start: 2009-04
• Study First Posted: 2009-04-01
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin aspart	-
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	at 24 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
Change in FPG (glucose variability)	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
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 PPG (postprandial control)	at 12 weeks and 24 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇴 Bucharest, Romania