Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin (Mix2Mix)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00775736
First received: October 17, 2008
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 50
Drug: biphasic insulin aspart 70

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)

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 episodes, reported during the study period. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic episodes. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]
  • Number of all adverse drug reactions. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Weight changes [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 611
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Other Name: BIAsp
Drug: biphasic insulin aspart 50
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Drug: biphasic insulin aspart 70
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.

Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • Known or suspected allergy to study product or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775736

Locations
Belgium
Brussels, Belgium, 1070
Luxembourg
Luxembourg, Luxembourg
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Dirk D'Hooge, MD sa Novo Nordisk Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00775736     History of Changes
Other Study ID Numbers: BIASP-3665
Study First Received: October 17, 2008
Last Updated: June 15, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Luxembourg: Villa Louvigny - Pharmacy and Pharmaceuticals Division

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 April 17, 2014