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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: 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
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
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014