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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: |
NCT00568984 |
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Date of registration:
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04/12/2007 |
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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 Repaglinide and Metformin Combined in Type 2 Diabetes
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Scientific title:
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Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus |
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Date of first enrolment:
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November 21, 2002 |
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Target sample size:
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324 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00568984 |
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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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China
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Malaysia
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Philippines
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Thailand
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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 3 months
- No previous treatment for diabetes
- HbA1c between 7.0-12.0%
- Body Mass Index (BMI) between 19.0-40.0 kg/m2
Exclusion Criteria:
- Type 1 diabetes
- Known unstable/untreated proliferative retinopathy
- Uncontrolled treated/untreated hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using
inadequate contraceptive measures
Age minimum:
18 Years
Age maximum:
99 Years
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 2
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Intervention(s)
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Drug: repaglinide
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Drug: metformin
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Drug: glicazide
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Primary Outcome(s)
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HbA1c
[Time Frame: after 16 weeks of treatment]
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Secondary Outcome(s)
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Glucose profiles
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Hypoglycaemic events
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Adverse events
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Quality of life assessment
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Treatment satisfaction
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Secondary ID(s)
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AGEE-3017
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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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