Observational Study of NovoMix� 50 for Treatment of Type 2 Diabetics for 12 Months
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 50 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Petra Sencar Bozic, MSc, Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in HbA1c
Secondary outcome: Percentage of subjects achieving target HbA1cChange in FPG (fasting plasma glucose) Change in PPG (postprandial glucose) Change in number of hypoglycaemic events Change in insulin presentation Dose and number of injections Number of ADRs (adverse drug reaction)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ljubljana SI-1000, Slovenia
Additional Information
Clinical Trials at Novo Nordisk
Starting date: September 2008
Last updated: August 12, 2014
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