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An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00696995
First received: June 11, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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


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: An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The number of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of all hypoglycaemic events [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at 12 weeks and 26 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose at visits [ Time Frame: at 12 weeks and 26 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Venous blood samples drawn as part of routine clinical evaluation


Enrollment: 509
Study Start Date: January 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 as well as dose alterations to be determined by the physician according to normal clinical evaluation
Other Name: NovoMix® 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with type 2 diabetes.

Criteria

Inclusion Criteria:

  • Patients with Type 2 diabetes
  • Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria:

  • Patients who are unlikely to comply with the protocol
  • Pregnancy or breastfeeding or intention of becoming pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696995

Locations
Finland
Lahti, Finland, 15110
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Tero Saukkonen Novo Nordisk Farma Oy
  More Information

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00696995     History of Changes
Other Study ID Numbers: BIASP-1917
Study First Received: June 11, 2008
Last Updated: June 15, 2012
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on June 18, 2013