Clinical trial NCT01467323: Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes:
measure: 8-point blood glucose profiles
measure: Incidence of hypoglycaemic episodes
measure: Occurrence of adverse events
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Anklam
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Cottbus
country: Germany
facility: Novo Nordisk Investigational Site
city: Erkner
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Jena
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Neunkirchen
country: Germany
facility: Novo Nordisk Investigational Site
city: Quakenbrück
country: Germany
facility: Novo Nordisk Investigational Site
city: Rostock
country: Germany
facility: Novo Nordisk Investigational Site
city: Saarlouis
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwedt
country: Germany
facility: Novo Nordisk Investigational Site
city: Ulm
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Cork
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin 9
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Bern
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Ayr
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bolton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Kettering
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Livingstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Newcastle
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Paisley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Whiston
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1046/j.1464-5491.2002.00733.x.
citation: Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam 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. doi: 10.2337/diacare.25.5.876.