Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00280046

Purpose

This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-measured 7-point capillary plasma glucose profile [ Designated as safety issue: No ]
Change in body weight [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes and adverse events [ Designated as safety issue: No ]
Quality of Life [ Designated as safety issue: No ]

Enrollment:	307
Study Start Date:	November 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
HbA1c: At least 8.0%

Exclusion Criteria:

Impaired hepatic, renal or cardiac function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280046

Locations

Russian Federation

Vladivostok, Russian Federation

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Ninella Starkova, MD, PhD

Novo Nordisk Russia

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-1554
Study First Received:	January 19, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00280046
Health Authority:	Russia: Federal Service for control in Health and Social development

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009