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

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ClinicalTrials.gov Identifier: NCT00696995
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Study Type : Observational
Actual Enrollment : 509 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




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

Secondary Outcome Measures :
  1. The number of all hypoglycaemic events [ Time Frame: at 26 weeks ]
  2. HbA1c [ Time Frame: at 12 weeks and 26 weeks ]
  3. 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


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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
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

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): 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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696995     History of Changes
Other Study ID Numbers: BIASP-1917
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 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
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs