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

Novo Nordisk A/S0 sites123 target enrollmentMarch 2002

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin aspart

Drugsinsulin aspart

Overview

Phase: Phase 4
Intervention: insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 123
Primary Endpoint: Incidence of hypoglycaemia
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

August 2003

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Eligibility Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

Insulin aspart

Intervention: insulin aspart

Outcomes

Primary Outcomes

Incidence of hypoglycaemia

Secondary Outcomes

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)