Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842894
First received: February 11, 2009
Last updated: June 28, 2012
Last verified: June 2012

February 11, 2009
June 28, 2012
May 2009
October 2010   (final data collection date for primary outcome measure)
Incidence of serious adverse drug reactions (SADRs) [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00842894 on ClinicalTrials.gov Archive Site
  • Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ] [ Designated as safety issue: Yes ]
  • Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • The effect on glycaemic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ] [ Designated as safety issue: Yes ]
  • Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

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

Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Safety and effectiveness data collection in connection with the use of the drug.
    Other Names:
    • NN304
    • Levemir®
  • Drug: biphasic insulin aspart 30
    Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.
  • Insulin detemir
    Intervention: Drug: insulin detemir
  • Biphasic insulin aspart 30
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1462
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Macedonia, The Former Yugoslav Republic of
 
NCT00842894
NN304-3716
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Ivica Smokovski Novo Nordisk Farma Dooel
Novo Nordisk A/S
June 2012

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