Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00671008
First received: April 30, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glycaemic control as measured by HbA1c [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects to reach HbA1c below 7.0% and =6.5% [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30 [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by FPG [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by PG profile [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30
B Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

  Eligibility

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

Type 1 and Type 2 Diabetes Mellitus

Criteria

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed
  • Age: Levemir® above 6 years
  • Age: Novomix® above 18 years

Exclusion Criteria:

  • Current treatment with NovoMix® 30 or Levemir®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671008

Locations
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Enisa Secerovic Walton, MD Novo Nordisk A/S, Bosnia & Herzegov (RO)
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00671008     History of Changes
Other Study ID Numbers: NN304-1964
Study First Received: April 30, 2008
Last Updated: July 24, 2012
Health Authority: Bosnia and Herzegovina: Federal Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014