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Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes (Start)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01486875
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

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: Week 26 ] [ Designated as safety issue: No ]
  • Incidence of major hypoglycaemic events [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic events [ Time Frame: In the 4 weeks prior to week 12 and week 26, respectively ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Enrollment: 1155
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BIAsp 30 Drug: biphasic insulin aspart 30
Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486875

Locations
Sweden
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Kerstin Magnusson Novo Nordisk
  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: NCT01486875     History of Changes
Other Study ID Numbers: BIASP-1721
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin aspart
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013