Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729898
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

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

Study Type : Observational
Actual Enrollment : 243 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes
Study Start Date : March 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30

Primary Outcome Measures :
  1. Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: after 12 and 26 weeks ]

Secondary Outcome Measures :
  1. Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks ]
  2. Number of all adverse drug reactions [ Time Frame: after 12 and 26 weeks ]
  3. HbA1c [ Time Frame: at 12 and 26 weeks ]
  4. Variability in fasting plasma glucose (FPG) values and average FPG levels [ Time Frame: at visits at 12 and 26 weeks ]
  5. Weight changes [ Time Frame: at visits at 12 and 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population type 2 diabetes strated on NovoMix® 30

Inclusion Criteria:

  • Any patient with diabetes type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months

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 identifier (NCT number): NCT00729898

Novo Nordisk Investigational Site
Rud, Norway, 1309
Novo Nordisk Investigational Site
Farsta, Sweden, 123 47
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00729898     History of Changes
Other Study ID Numbers: BIASP-3512
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

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 Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs