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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01650129

Enrollment

Registered

2012-07-26

Start date

2000-12-13

Completion date

2001-10-18

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief 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.

Interventions

DRUGbiphasic insulin aspart 50

Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner

DRUGbiphasic human insulin 50

Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Glycosylated haemoglobin A1c (HbA1c)	—

Secondary

Measure	Time frame
Occurrence of adverse event(s)	—
Blood glucose	—
Incidence of hypoglycaemic episodes	—
Change from baseline in insulin antibodies	—
Insulin doses	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026