Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650129
• Other study ID #: BIASP-1352
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: February 22, 2017
• Start date: December 13, 2000
• Est. completion date: October 18, 2001

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 18, 2001
• Est. primary completion date: October 18, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects with type 2 diabetes

• Subjects with insulin treated for at least 24 weeks

• HbA1c maximum 11.0%

• Body mass index (BMI) below 30.0 kg/m^2

• Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

• Recurrent severe hypoglycaemia

• Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year

• Impaired hepatic function

• Impaired renal function

• Cardiac diseases

• Uncontrolled hypertension

• Subjects with history of severe allergic or severe hypersensitive reactions

• Total daily insulin dose at least 100 IU

• Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
• biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated haemoglobin A1c (HbA1c)
Secondary	Occurrence of adverse event(s)
Secondary	Blood glucose
Secondary	Incidence of hypoglycaemic episodes
Secondary	Change from baseline in insulin antibodies
Secondary	Insulin doses

External Links

•   Clinical Trials at Novo Nordisk