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Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00593255
Enrollment
220
Registered
2008-01-14
Start date
2004-07-31
Completion date
2005-04-30
Last updated
2016-12-22

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 compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

Interventions

DRUGinsulin aspart
DRUGinsulin NPH

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 65 Years
Healthy volunteers
No

Inclusion criteria

* Type 1 or 2 diabetes for at least 4 weeks * Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks * HbA1c: 7.5-13.5% * Body Mass Index (BMI): 18-35 kg/m2

Exclusion criteria

* Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation * History of drug abuse or alcohol dependence

Design outcomes

Primary

MeasureTime frame
2-hours postprandial plasma glucose (PPPG)after 12 weeks of treatment

Secondary

MeasureTime frame
Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes

Countries

China

Outcome results

None listed

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