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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: |
NCT00619697 |
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Date of registration:
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11/02/2008 |
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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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Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
EUROMIX |
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Scientific title:
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Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00619697 |
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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 4
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Countries of recruitment
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Austria
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Czech Republic
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Germany
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Hungary
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Poland
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Slovakia
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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 for at least 6 months
- Insulin naive. Short term insulin treatment (7 days or less within the last 6 months)
is allowed
- Previous treatment with oral antidiabetic drugs for at least 4 months
- Judged by the investigator to be eligible for an insulin analogue plus oral
antidiabetic drug treatment regimen
- BMI below 40 kg/m2
- HbA1c between 7-12%
- Able and willing to perform self-plasma glucose monitoring
Exclusion Criteria:
- The receipt of any other investigational drug within 4 weeks before screening
- A history of drug or alcohol abuse within the last 12 months
- Severe, uncontrolled hypertension
- Known or suspected allergy to trial products or related products
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 Mellitus, Type 2
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Diabetes
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Intervention(s)
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Drug: biphasic insulin aspart
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Drug: insulin glargine
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Drug: glimepiride
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Drug: metformin
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Primary Outcome(s)
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HbA1c
[Time Frame: after 26 weeks of treatment]
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Secondary Outcome(s)
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Incidence of hypoglycaemic episodes
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Safety profile
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Plasma glucose profiles
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Change in body mass index
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HbA1c
[Time Frame: after 16 weeks of treatment]
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Secondary ID(s)
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BIASP-1564
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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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