Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00676741

Purpose

The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin aspart Drug: biphasic insulin aspart 30 Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Diabetes type 2

Criteria

Inclusion Criteria:

Patients with type 2 diabetes
Patients treated with human soluble insulin, NPH insulin or premixed human insulin
Patients willing to sign informed consent
Selection of study participants at the discretion of the physician

Exclusion Criteria:

Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
Subjects who were previously enrolled in this study
Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676741

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Slovakia
	Recruiting
Bratislava, Slovakia, 811 05

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jozef Lacka, M.D. CSc.

Novo Nordisk Slovakia, s.r.o

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-3516
Study First Received:	May 9, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00676741
Health Authority:	Slovakia: State Institute for Drug Control

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 14, 2009