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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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16 December 2017 |
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Main ID: |
NCT01467323 |
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Date of registration:
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04/11/2011 |
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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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Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
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Scientific title:
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An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects |
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Date of first enrolment:
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April 1998 |
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Target sample size:
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303 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01467323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Germany
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Ireland
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Switzerland
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United Kingdom
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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:
- Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
- Current treatment with human insulin (either premix of short and long/intermediate
acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at
least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m^2
- HbA1c below or equal to 11.0%
Exclusion Criteria:
- Total daily insulin dose at least 1.4 IU/kg
- Treatment with oral hypoglycaemic agents within the month prior to inclusion
- Recurrent severe hypoglycaemia (as judged by the investigator)
- Active proliferative retinopathy
- Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
- History of pancreatitis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes
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Diabetes Mellitus, Type 1
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: biphasic insulin aspart
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Drug: biphasic human insulin
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Primary Outcome(s)
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HbA1c (glycosylated haemoglobin A1c)
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Secondary Outcome(s)
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8-point blood glucose profiles
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Occurrence of adverse events
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Incidence of hypoglycaemic episodes
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Secondary ID(s)
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ANA/DCD/038
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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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