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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873639
• Other study ID #: INS-3721
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: October 13, 2016
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin aspart
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
• insulin detemir
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

Locations

Country	Name	City	State
Romania	Novo Nordisk Investigational Site	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		at 24 weeks from baseline	No
Secondary	Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%		at 12 weeks and 24 weeks of treatment	No
Secondary	Change in FPG (glucose variability)		at 12 weeks and 24 weeks of treatment	No
Secondary	Change in PPG (postprandial control)		at 12 weeks and 24 weeks of treatment	No
Secondary	Change in insulin dose and number of injections		at 12 weeks and 24 weeks of treatment	No
Secondary	Change in body weight		at 12 weeks and 24 weeks of treatment	No
Secondary	Change in number of hypoglycaemic events		at 12 weeks and 24 weeks of treatment	Yes
Secondary	Number of adverse drug reactions (ADR)		at 12 weeks and 24 weeks of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk