Status:

COMPLETED

Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Eligibility Criteria

Inclusion

  • Type 2 diabetes for at least 6 months
  • Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
  • Previous treatment with oral antidiabetic drugs for at least 4 months
  • Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
  • BMI below 40 kg/m2
  • HbA1c between 7-12%
  • Able and willing to perform self-plasma glucose monitoring

Exclusion

  • The receipt of any other investigational drug within 4 weeks before screening
  • A history of drug or alcohol abuse within the last 12 months
  • Severe, uncontrolled hypertension
  • Known or suspected allergy to trial products or related products

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2005

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT00619697

Start Date

December 1 2003

End Date

March 1 2005

Last Update

January 6 2017

Active Locations (54)

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Page 1 of 14 (54 locations)

1

Novo Nordisk Investigational Site

Ebreichsdorf, Austria, 2483

2

Novo Nordisk Investigational Site

Feldkirch, Austria, 6807

3

Novo Nordisk Investigational Site

Graz, Austria, 8036

4

Novo Nordisk Investigational Site

Horn, Austria, A 3580