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Clinical Trials/NCT00873639
NCT00873639CompletedNot Applicable

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

Novo Nordisk A/S1 site in 1 country417 target enrollmentStarted: April 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
417
Locations
1
Primary Endpoint
Change in HbA1c
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Intervention: insulin aspart (Drug)

A

Intervention: insulin detemir (Drug)

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: at 24 weeks from baseline

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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