Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00671008
NCT00671008
Completed
Not Applicable

Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

Novo Nordisk A/S0 sites400 target enrollmentStarted: December 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Interventionsbiphasic insulin aspart 30insulin detemir
Drugsbiphasic insulin aspart 30insulin detemir

Overview

Phase
Not Applicable
Status
Completed
Enrollment
400
Primary Endpoint
Glycaemic control as measured by HbA1c
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & 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

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with Type 1 or Type 2 diabetes, including newly diagnosed
  • •Age: Levemir® above 6 years
  • •Age: Novomix® above 18 years

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

Glycaemic control as measured by HbA1c

Time Frame: After 24 weeks

Secondary Outcomes

  • Percentage of subjects to reach HbA1c below 7.0% and =6.5%(After 24 weeks)
  • Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30(After 24 weeks)
  • The effect on glycamic control as measured by FPG(After 24 weeks)
  • The effect on glycamic control as measured by PG profile(After 24 weeks)
  • Change in body weight(After 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Phase 3
Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT00184574Novo Nordisk A/S603
Completed
Not Applicable
Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin TreatmentDiabetesDiabetes Mellitus, Type 2
NCT00865397Novo Nordisk A/S1,032
Completed
Not Applicable
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2
NCT00687284Novo Nordisk A/S2,188
Completed
Not Applicable
Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern InsulinDiabetesDiabetes Mellitus, Type 2
NCT00670722Novo Nordisk A/S6,500
Completed
Phase 4
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT01697631Novo Nordisk A/S131