Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart Drug: insulin NPH Drug: insulin aspart	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin aspart Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 4 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

8-point blood glucose profile [ Designated as safety issue: No ]
incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
safety profiles [ Designated as safety issue: No ]
changes in body weight and vital signs [ Designated as safety issue: No ]

Estimated Enrollment:	395
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600626

Locations


Croatia

	Zagreb, Croatia, 10 000

France

	LILLE, France, 59037

Germany

	Neuss, Germany, 41460

Hong Kong

	Hong Kong, Hong Kong

Malaysia, Kuala Lumpur

	Cheras, Kuala Lumpur, Malaysia, 56000

Netherlands

	Beverwijk, Netherlands, 1942 LE

Poland

	Lodz, Poland, 90-030

Romania

	Timisoara, Romania, 300736

Russian Federation, Russia

	St. Petersburg, Russia, Russian Federation, 194354

Singapore

	Singapore, Singapore, 119074

Spain

	Sevilla, Spain, 41009

Sweden

	Lund, Sweden, 221 85

United Kingdom

	York, United Kingdom, YO3 7HE

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Plamen Kozlovski	Novo Nordisk A/S

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1486
First Received:	January 14, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00600626
Health Authority:	Croatia: Ministry of Health and Social Care; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hong Kong: Department of Health; Malaysia: Ministry of Health; Netherlands: Dutch Health Care Inspectorate; Poland: The Office for Reg. of Medicinal Products, Medical Devices; Romania: State Institute for Drug Control; Russia: Federal Service for Control of Health Care and Social Developme; Singapore: Health Sciences Authority; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency