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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00771680
First received: October 9, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

This study is conducted in Europe and Asia. 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 subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 10408
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency at the discretion of the physician following clinical practice
Drug: biphasic insulin aspart 30
Start dose and frequency at the discretion of the physician following clinical practice
Drug: insulin aspart
Start dose and frequency 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 of 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

Locations
Russian Federation
Moscow, Russian Federation, 119330
Ukraine
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: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00771680     History of Changes
Other Study ID Numbers: INS-3655
Study First Received: October 9, 2008
Last Updated: July 12, 2012
Health Authority: Russia: Federal Service for quality Control of Medical Products
Ukraine: Not required for observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013