Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01649570

Enrollment

123

Registered

2012-07-25

Start date

2002-03-31

Completion date

2003-08-31

Last updated

2012-07-25

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 NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Interventions

DRUGinsulin aspart

Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks * HbA1c below or equal to 11.0% * BMI (body mass index) below 30 kg/m\^2

Design outcomes

Primary

Measure	Time frame
Incidence of hypoglycaemia	—

Secondary

Measure	Time frame
Incidence of adverse events (AEs)	—
Clinical laboratory tests: Haematology and biochemistry	—
Insulin antibodies	—
Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026