Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00771680

Purpose

This study is conducted in Europe and Asian

The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in type 2 diabetes patients that have not used insulin previously under normal clinical practice conditions.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: at baseline visit and during 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Serious adverse drug reactions including major hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious adverse drug reactions [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: During 4 weeks prior to each study visit ] [ Designated as safety issue: No ]
Weight (BMI) change [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]
Variability in fasting blood glucose values and average (mean) fasting blood glucose level [ Time Frame: At baseline visit and after 6 and 12 months treatment ] [ Designated as safety issue: No ]
Average post-prandial blood glucose level (2h after dinner) [ Time Frame: At baseline visit and after 6 and 12 months treatment ] [ Designated as safety issue: No ]
Quality of Life (QoL) as assessed by patient questionnaire [ Time Frame: At baseline and the end of 6 and 12 months treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10000
Study Start Date:	October 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir Start dose and freqency at the discretion of the physician following clinical practice Drug: biphasic insulin aspart 30 Start dose and freqency at the discretion of the physician following clinical practice Drug: insulin aspart Start dose and freqency at the discretion of the physician following clinical practice

Eligibility

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

Study Population

Patients from both genders, who in practice settings,have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria:

In accordance with approved label

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771680

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Russian Federation
	Recruiting
Moscow, Russian Federation, 119330
Ukraine
	Recruiting
Kiev, Ukraine, 252030

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Anna Makarenko, Veterinary Dr	Novo Nordisk
Study Director:	Akeel Ballan, RN,MSc,BAcom	Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	INS-3655
Study First Received:	October 9, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00771680 History of Changes
Health Authority:	Russia: Federal Service for quality Control of Medical Products; Ukraine: Not required for observational study

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009