Diabetes Mellitus, Type 2 Clinical Trial
Official title:
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
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.
| Status | Completed |
| Enrollment | 303 |
| Est. completion date | September 1998 |
| Est. primary completion date | September 1998 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months - Body mass index (BMI) below or equal to 35.0 kg/m^2 - HbA1c below or equal to 11.0% 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Germany | Novo Nordisk Investigational Site | Anklam | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Cottbus | |
| Germany | Novo Nordisk Investigational Site | Erkner | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Jena | |
| Germany | Novo Nordisk Investigational Site | Leipzig | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Neunkirchen | |
| Germany | Novo Nordisk Investigational Site | Quakenbrück | |
| Germany | Novo Nordisk Investigational Site | Rostock | |
| Germany | Novo Nordisk Investigational Site | Saarlouis | |
| Germany | Novo Nordisk Investigational Site | Schwedt | |
| Germany | Novo Nordisk Investigational Site | Ulm | |
| Germany | Novo Nordisk Investigational Site | Würzburg | |
| Ireland | Novo Nordisk Investigational Site | Cork | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin 9 | |
| Switzerland | Novo Nordisk Investigational Site | Bern | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Blackburn | |
| United Kingdom | Novo Nordisk Investigational Site | Bolton | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Kettering | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | Newcastle | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Paisley | |
| United Kingdom | Novo Nordisk Investigational Site | Watford | |
| United Kingdom | Novo Nordisk Investigational Site | Whiston |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Germany, Ireland, Switzerland, United Kingdom,
Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. Erratum in: Diabet Med. 2002 Sep;19(9) — View Citation
Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Råstam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycosylated haemoglobin A1c) | No | ||
| Secondary | 8-point blood glucose profiles | No | ||
| Secondary | Incidence of hypoglycaemic episodes | No | ||
| Secondary | Occurrence of adverse events | No |
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