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

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ClinicalTrials.gov Identifier: NCT00755833
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 50

Study Type : Observational
Actual Enrollment : 270 participants
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
Study Start Date : September 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving target HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]
  2. Change in FPG (fasting plasma glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  3. Change in PPG (postprandial glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  4. Change in number of hypoglycaemic events [ Time Frame: At 0, 3, 6, 9, 12 months ]
  5. Change in insulin presentation [ Time Frame: At 0, 3, 6, 9, 12 months ]
  6. Dose and number of injections [ Time Frame: At 0, 3, 6, 9, 12 months ]
  7. Number of ADRs (adverse drug reaction) [ Time Frame: At 0, 3, 6, 9, 12 months ]


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00755833


Locations
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00755833     History of Changes
Other Study ID Numbers: BIASP-3674
First Posted: September 19, 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
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs