Text Size

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
ClinicalTrials.gov Identifier:
NCT00842894
First received: February 11, 2009
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions (SADRs) [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1462
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin detemir Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of the drug.
Other Names:
  • NN304
  • Levemir®
Biphasic insulin aspart 30 Drug: biphasic insulin aspart 30
Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842894

Locations
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ivica Smokovski Novo Nordisk Farma Dooel
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00842894     History of Changes
Other Study ID Numbers: NN304-3716
Study First Received: February 11, 2009
Last Updated: June 28, 2012
Health Authority: Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health

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 June 18, 2013