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

A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00617565
Enrollment
219
Registered
2008-02-18
Start date
2003-07-08
Completion date
2003-11-26
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 1, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

Interventions

DRUGbiphasic insulin aspart

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Type 1 or 2 diabetes for at least 3 months * Stabilised on current treatment with premixed human insulin for at least 4 weeks * Body mass index (BMI) between 18-40 kg/m2 * HbA1c below 13.0% * Able and willing to perform self-blood glucose monitoring

Exclusion criteria

* The receipt of any investigational drug within the last three months prior to this trial * Has a history of drug abuse or alcohol dependence within the last 5 years * Active proliferative retinopathy requiring laser or surgical intervention within the last year * Recurrent major hypoglycaemia as judged by the Investigator * Known or suspected allergy to trial product or related product

Design outcomes

Primary

MeasureTime frame
2-hr postprandial plasma glucose (PPPG) excursionafter 12 weeks of treatment

Secondary

MeasureTime frame
HbA1c
Fasting plasma glucose

Countries

China

Outcome results

None listed

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