Clinical trial NCT00624364: Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes
Official title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With 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: 2008-02-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
* Body mass index (BMI) below 40.0 kg/m2
* HbA1c between 7.5-13.0%

Exclusion Criteria:

* History of drug or alcohol dependence
* Mental incapacity, unwillingness or language barriers precluding adequate
* Subjects previously screened to participation or having already participated 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
timeFrame: after 24 weeks of treatment
Secondary outcomes:
measure: Plasma glucose profiles
measure: Cardiovascular risk factors
measure: Incidence of hypoglycaemic episodes
measure: Adverse events
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Pietermaritzburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Benoni
country: South Africa
facility: Novo Nordisk Investigational Site
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
city: Kimberley
country: South Africa
facility: Novo Nordisk Investigational Site
city: Richards Bay
country: South Africa
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Naiker P, Makan HA, Kedijang T, Kong LLL, Omar MAK & the BIAsp-1579 Study Group. Effects of Once-Daily Biphasic Insulin Aspart 30 with Metformin versus Twice-Daily Biphasic Insulin Aspart 30 in South African Type 2 Diabetes Subjects. Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA); Country: South Africa City: Bloemfontein
citation: Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Effect of biphasic insulin aspart 30/70 (BIAsp30) in combination with metformin on glycaemic control in subjects with type 2 diabetes not optimally controlled on oral antidiabetic agents. EASD 2006 2006; 49(Suppl 1): 599
citation: Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Efficacy of biphasic insulin aspart 30/70 with metformin on glycaemic control in poorly-controlled type 2 diabetes. IDF 2006 2006; 23(Suppl 4): 339 (P940)