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 A/S
ClinicalTrials.gov Identifier:
NCT00771680
First received: October 9, 2008
Last updated: July 12, 2012
Last verified: July 2012

October 9, 2008
July 12, 2012
October 2008
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00771680 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
A
Interventions:
  • Drug: insulin detemir
  • Drug: biphasic insulin aspart 30
  • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10408
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Ukraine
 
NCT00771680
INS-3655
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Anna Makarenko, Veterinary Dr Novo Nordisk A/S
Study Director: Akeel Ballan, RN,MSc,BAcom Novo Nordisk A/S
Novo Nordisk A/S
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP