Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467323

Enrollment

303

Registered

2011-11-08

Start date

1998-04-30

Completion date

1998-09-30

Last updated

2017-01-04

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

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Interventions

DRUGbiphasic insulin aspart

Injected subcutaneously (under the skin) twice daily

DRUGbiphasic human insulin

Injected subcutaneously (under the skin) twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months * Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months * Body mass index (BMI) below or equal to 35.0 kg/m\^2 * HbA1c below or equal to 11.0%

Exclusion criteria

* Total daily insulin dose at least 1.4 IU/kg * Treatment with oral hypoglycaemic agents within the month prior to inclusion * Recurrent severe hypoglycaemia (as judged by the investigator) * Active proliferative retinopathy * Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl) * History of pancreatitis

Design outcomes

Primary

Measure	Time frame
HbA1c (glycosylated haemoglobin A1c)	—

Secondary

Measure	Time frame
8-point blood glucose profiles	—
Incidence of hypoglycaemic episodes	—
Occurrence of adverse events	—

Countries

Austria, Germany, Ireland, Switzerland, United Kingdom

Outcome results

None listed

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