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

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ClinicalTrials.gov Identifier: NCT01542424
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 1889 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia
Study Start Date : March 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Prescribed at the discretion of the physician

IDet users Drug: insulin detemir
Prescribed at the discretion of the physician




Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Percentage of subjects reaching HbA1c target of maximum 7.0%
  2. Postprandial plasma glucose (PPG)
  3. Fasting plasma glucose (FPG)
  4. Change in body weight
  5. Incidence of adverse events


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Macedonian people with diabetes mellitus (Type 1 or Type 2)
Criteria

Inclusion Criteria:

  • Macedonian people with diabetes mellitus (Type 1 or Type 2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542424


Locations
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542424     History of Changes
Other Study ID Numbers: NN304-1763
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

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
Insulin Detemir
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs