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NCT00600626 Clinical Trial

Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00600626
Other study ID # BIASP-1486
Secondary ID
Status Completed
Phase Phase 3
First received January 14, 2008
Last updated January 5, 2017
Start date January 2004
Est. completion date July 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Croatia: Ministry of Health and Social CareFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthMalaysia: Ministry of HealthNetherlands: Dutch Health Care InspectoratePoland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical TrialsRomania: State Institute for Drug ControlRussia: Federal Service for Control of Health Care and Social DevelopmentSingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 394
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs

- HbA1c between 8.0-10.5%

- Body mass index (BMI) below 35.0 kg/m2

- Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

- Total daily insulin dose of 1.80 IU/kg or more

- Known or suspected allergy to trial product or related products

- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

• insulin NPH

• insulin aspart

Locations
Country Name City State
Croatia Novo Nordisk Investigational Site Zagreb
France Novo Nordisk Investigational Site Lille
France Novo Nordisk Investigational Site NEVERS cedex
France Novo Nordisk Investigational Site Rennes
France Novo Nordisk Investigational Site Venissieux
Germany Novo Nordisk Investigational Site Bad Heilbrunn
Germany Novo Nordisk Investigational Site Neuss
Germany Novo Nordisk Investigational Site Schaafheim
Germany Novo Nordisk Investigational Site Schwedt
Germany Novo Nordisk Investigational Site St. Ingbert
Germany Novo Nordisk Investigational Site Völklingen
Germany Novo Nordisk Investigational Site Wiesbaden
Germany Novo Nordisk Investigational Site Würzburg
Hong Kong Novo Nordisk Investigational Site Shatin, New Territories
Malaysia Novo Nordisk Investigational Site Cheras
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Netherlands Novo Nordisk Investigational Site Beverwijk
Netherlands Novo Nordisk Investigational Site Delft
Netherlands Novo Nordisk Investigational Site Eindhoven
Netherlands Novo Nordisk Investigational Site Rotterdam
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Szczecin
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Zabrze
Romania Novo Nordisk Investigational Site Cluj Napoca Cluj
Romania Novo Nordisk Investigational Site Constanta
Romania Novo Nordisk Investigational Site Iasi
Romania Novo Nordisk Investigational Site Timisoara
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Singapore Novo Nordisk Investigational Site Singapore
Spain Novo Nordisk Investigational Site Córdoba
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Orihuela
Spain Novo Nordisk Investigational Site Sabadell
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Valladolid
Sweden Novo Nordisk Investigational Site Falun
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Linköping
Sweden Novo Nordisk Investigational Site Lund
Sweden Novo Nordisk Investigational Site Mölndal
Sweden Novo Nordisk Investigational Site Uppsala
United Kingdom Novo Nordisk Investigational Site Bradford
United Kingdom Novo Nordisk Investigational Site Brighton
United Kingdom Novo Nordisk Investigational Site Coventry
United Kingdom Novo Nordisk Investigational Site Edinburgh
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Northampton
United Kingdom Novo Nordisk Investigational Site Plymouth
United Kingdom Novo Nordisk Investigational Site York

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

Countries where clinical trial is conducted

Croatia,  France,  Germany,  Hong Kong,  Malaysia,  Netherlands,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel grou — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 4 months of treatment No
Secondary 8-point blood glucose profile No
Secondary incidence of hypoglycaemic episodes No
Secondary safety profiles No
Secondary changes in body weight and vital signs No
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