Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600366
• Other study ID #: BIASP-1566
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: January 5, 2017
• Start date: March 2004
• Est. completion date: January 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Medicines and Medical Devices Agency of Serbia
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Insulin naive diabetes

• Current treatment with OHA, secondary failure

• Body mass index (BMI) below 40 kg/m2

• HbA1c over 8.5%

• Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria:

• History of drug or alcohol abuse

• Receipt of the investigational drug within the last month prior to this trial

• Known or suspected allergy to trial products or related products

• Severe uncontrolled hypertension

• Any disease or condition, which the Investigator feels, would interfere with the trial

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart

Locations

Country	Name	City	State
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Belgrade
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Kragujevac
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Nis
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Former Serbia and Montenegro, 

References & Publications (1)

Lalic NM, Micic D, Antic S, Bajovic L, Pantelinac P, Jotic A, Kendereski A, Dimic D, Djukic A, Mitrovic M, Vujasin M. Effect of biphasic insulin aspart on glucose and lipid control in patients with Type 2 diabetes mellitus. Expert Opin Pharmacother. 2007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 12 weeks of treatment	No
Secondary	Blood glucose profiles			No
Secondary	Incidence of hypoglycaemic episodes			No
Secondary	Incidence of adverse events			No

External Links

•   Clinical Trials at Novo Nordisk