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NCT01649570 Clinical Trial

Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01649570
Other study ID # ANA-1472
Secondary ID
Status Completed
Phase Phase 4
First received November 25, 2011
Last updated July 24, 2012
Start date March 2002
Est. completion date August 2003

Study information
Verified date July 2012
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date August 2003
Est. primary completion date August 2003
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hypoglycaemia No
Secondary Incidence of adverse events (AEs) No
Secondary Clinical laboratory tests: Haematology and biochemistry No
Secondary Insulin antibodies No
Secondary Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG) No
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