Clinical trial NCT01697631: Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
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: 2012-10-02
Enrollment: 131
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 this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
* HbA1c (glycosylated haemoglobin) equal to or below 12%
* Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

* History of drug or alcohol dependence
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Previous participation in this trial
* Receipt of any investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: 7-point blood glucose profile
measure: Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
measure: Incidence of adverse events
measure: Hypoglycaemic episodes (minor, major or nocturnal)
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bytom
country: Poland
facility: Novo Nordisk Investigational Site
city: Kamieniec Zabkowicki
country: Poland
facility: Novo Nordisk Investigational Site
city: Katowice
country: Poland
facility: Novo Nordisk Investigational Site
city: Krakow
country: Poland
facility: Novo Nordisk Investigational Site
city: Nysa
country: Poland
facility: Novo Nordisk Investigational Site
city: Otwock
country: Poland
facility: Novo Nordisk Investigational Site
city: Radom
country: Poland
facility: Novo Nordisk Investigational Site
city: Ruda Slaska
country: Poland
facility: Novo Nordisk Investigational Site
city: Sosnowiec
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: