Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

Last updated: January 3, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT01467323
ANA/DCD/038
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months

  • Current treatment with human insulin (either premix of short and long/intermediateacting insulin) in a twice daily treatment regimen preparation and/or self-mix for atleast 12 months

  • Body mass index (BMI) below or equal to 35.0 kg/m^2

  • HbA1c below or equal to 11.0%

Exclusion

Exclusion Criteria:

  • Total daily insulin dose at least 1.4 IU/kg

  • Treatment with oral hypoglycaemic agents within the month prior to inclusion

  • Recurrent severe hypoglycaemia (as judged by the investigator)

  • Active proliferative retinopathy

  • Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)

  • History of pancreatitis

Study Design

Total Participants: 303
Study Start date:
April 01, 1998
Estimated Completion Date:
September 30, 1998

Connect with a study center

  • Novo Nordisk Investigational Site

    Graz, 8036
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, A 1080
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Anklam, 17389
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 10559
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Cottbus, 03048
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Erkner, 15537
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 20251
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Jena, 07743
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Leipzig, 04177
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    München, 80804
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Neunkirchen, 66538
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Quakenbrück, 49610
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rostock, 18057
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saarlouis, 66740
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Schwedt, 16303
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Würzburg, 97080
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Cork,
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Dublin, DUBLIN 8
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Dublin 9,
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bern, 3010
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Ayr, KA6 6DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Blackburn, BB3 3LR
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bolton, BL1 4QS
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Kettering, NN16 8UZ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Livingstone, EH54 6PP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Northampton, NN1 5BD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Paisley, PA2 9PL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Watford, WD18 0HB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Whiston, L35 5DR
    United Kingdom

    Site Not Available

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