Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix® 30 - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00675493

Purpose

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

Condition	Intervention
Diabetes Mellitus	Drug: biphasic insulin aspart 30

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Glycaemic Control of NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c from baseline [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% [ Time Frame: after 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in FPG (glucose variability) [ Time Frame: after 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in PPG (postprandial control) [ Time Frame: after 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in insulin dose and number of injections [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in oral antidiabetic drug therapy [ Time Frame: after 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
Change in number of hypoglycaemic events [ Time Frame: during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Number of adverse drug reactions (ADR) [ Time Frame: after 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: biphasic insulin aspart 30 Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Eligibility

Ages Eligible for Study:	10 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type 1 and type 2 diabetes patients inadequately controlled on human premixes

Criteria

Inclusion Criteria:

Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria:

Subjects currently being treated with biphasic insulin aspart 30
Subjects who were previously enrolled in this study
Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
Women who are pregnant or have the intention of becoming pregnant within next 6 months
Children below 10 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675493

Locations

Romania

Bucharest, Romania, 010031

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Emiliana Corina Mocan

Novo Nordisk Farma

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-3567
Study First Received:	May 7, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00675493
Health Authority:	Romania: National Medicines Agency

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 16, 2009