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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: January 10, 2017
Last verified: January 2017
  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. ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic episodes. [ Time Frame: At baseline, 12 and 26 weeks. ]
  • Number of all adverse drug reactions. [ Time Frame: At baseline, 12 and 26 weeks. ]
  • HbA1c [ Time Frame: at 12 and 26 weeks ]
  • Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels [ Time Frame: at 12 and 26 weeks ]
  • Weight changes [ Time Frame: at 12 and 26 weeks ]

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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: NCT00775736

Locations
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Luxembourg
Novo Nordisk Investigational Site
Luxembourg, Luxembourg
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: NCT00775736     History of Changes
Other Study ID Numbers: BIASP-3665
Study First Received: October 17, 2008
Last Updated: January 10, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017