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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00696995
First received: June 11, 2008
Last updated: January 6, 2017
Last verified: January 2017
  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:


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

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

Secondary Outcome Measures:
  • The number of all hypoglycaemic events [ Time Frame: at 26 weeks ]
  • HbA1c [ Time Frame: at 12 weeks and 26 weeks ]
  • Fasting plasma glucose at visits [ Time Frame: at 12 weeks and 26 weeks ]

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:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00696995

Locations
Finland
Novo Nordisk Investigational Site
Lahti, Finland, 15110
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696995     History of Changes
Other Study ID Numbers: BIASP-1917 
Study First Received: June 11, 2008
Last Updated: January 6, 2017

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

ClinicalTrials.gov processed this record on February 24, 2017