Clinical trial NCT01487798: Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: A Double-blind, Randomised, Crossover Study to Investigate the Difference in Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 Compared to Biphasic Human Insulin 30 in Patients With Well-controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Treated with insulin 1-3 injections daily for at least 6 months
* Body Mass Index (BMI) below 40 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening

Exclusion Criteria:

* Total insulin dosage more than 1.8 IU/kg
* Impaired hepatic or renal function or significant cardiac problems

Primary outcomes:
measure: Frequency of hypoglycaemic episodes
Secondary outcomes:
measure: Frequency of reported severe hypoglycaemic episodes
measure: Overall frequency of nocturnal hypoglycaemia
measure: HbA1c (glycosylated haemoglobin A1c)
measure: Diabetes Treatment Satisfaction Questionaire
Other outcomes:
Locations:
city: Bolton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cardiff
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Exeter
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Galway
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Newcastle
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Upton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: York
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: McNally PG, Dean JD, Morris AD, Wilkinson PD, Compion G, Heller SR. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care. 2007 May;30(5):1044-8. doi: 10.2337/dc06-1328. Epub 2007 Feb 2.