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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT00755833 |
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Date of registration:
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18/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
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Scientific title:
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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 |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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270 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00755833 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: biphasic insulin aspart 50
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Primary Outcome(s)
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Change in HbA1c
[Time Frame: At 0, 3, 6, 9, 12 months]
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Secondary Outcome(s)
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Change in insulin presentation
[Time Frame: At 0, 3, 6, 9, 12 months]
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Change in FPG (fasting plasma glucose)
[Time Frame: At 0, 3, 6, 9, 12 months]
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Percentage of subjects achieving target HbA1c
[Time Frame: At 0, 3, 6, 9, 12 months]
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Change in number of hypoglycaemic events
[Time Frame: At 0, 3, 6, 9, 12 months]
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Change in PPG (postprandial glucose)
[Time Frame: At 0, 3, 6, 9, 12 months]
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Dose and number of injections
[Time Frame: At 0, 3, 6, 9, 12 months]
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Number of ADRs (adverse drug reaction)
[Time Frame: At 0, 3, 6, 9, 12 months]
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Secondary ID(s)
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BIASP-3674
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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