Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00665093
NCT00665093
Completed
Not Applicable

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Novo Nordisk A/S1 site in 1 country1,569 target enrollmentStarted: May 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Interventionsbiphasic insulin aspart 30insulin detemir

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1,569
Locations
1
Primary Endpoint
HbA1c
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Levemir® above 6 yrs
  • •NovoMix® 30 above 18 yrs
  • •Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria

  • •Current treatment with NovoMix® 30 or Levemir®

Arms & Interventions

A

Intervention: biphasic insulin aspart 30 (Drug)

B

Intervention: insulin detemir (Drug)

Outcomes

Primary Outcomes

HbA1c

Time Frame: at 24 weeks

Secondary Outcomes

  • FPG, PG profile, weight, % of subjects on target(at 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
NCT00675493Novo Nordisk A/S942
Completed
Not Applicable
Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin AnaloguesDiabetesDiabetes Mellitus, Type 1
NCT00873639Novo Nordisk A/S417
Completed
Not Applicable
Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT01288326Novo Nordisk A/S254
Completed
Not Applicable
Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 MonthsDiabetesDiabetes Mellitus, Type 2
NCT00755833Novo Nordisk A/S270
Completed
Phase 3
Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With DiabetesDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
NCT01520818Novo Nordisk A/S666