Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin aspart

• Registration Number: NCT01649570
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2011-11-25
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-24
• Last Update Submitted: 2012-07-24
• Study First Posted: 2012-07-25
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin aspart	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of hypoglycaemia

Secondary Outcome Measures

Name	Time	Method
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)