Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00755833
First received: September 18, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects achieving target HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in FPG (fasting plasma glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in insulin presentation [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Dose and number of injections [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Number of ADRs (adverse drug reaction) [ Time Frame: At 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
Other Name: NovoMix® 50

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

  • Type 2 diabetes treated with biphasic human insulin with or without metformin
  • Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
  • Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
  • Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 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: NCT00755833

Locations
Slovenia
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Petra Sencar Bozic, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00755833     History of Changes
Other Study ID Numbers: BIASP-3674
Study First Received: September 18, 2008
Last Updated: August 12, 2014
Health Authority: Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014