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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00518427 |
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Date of registration:
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17/08/2007 |
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Primary sponsor: |
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Public title:
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Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine
QoL |
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Scientific title:
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A Multicenter Clinical Trial to Evaluate Quality of Life in Patients With Type 2 Diabetes Before and After Changing Therapy to a Combination of Insulin Glargine and Oral Antidiabetic Drugs in a Real Life Situation |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00518427 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Margareta Olsson-Birgersson |
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Address:
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Telephone:
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Email:
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Affiliation:
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sanofi-aventis, Sweden |
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Key inclusion & exclusion criteria
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lists of inclusion and exclusion criteria:
Inclusion Criteria:
- Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH
insulin for more than three months
- Stable OAD therapy for at least three months, according to the following specified
daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimeperid >2mg, metformin>1000
mg, acarbose >150 mg
- HbA1c > 7,0%
- Ability to perform QoL assessment
- Body Mass Indes: women <30 and men <32
Exlusion criteria:
- Autoimmune diabetes, as defined by WHO
- Ongoing treatment with tiasolidindion drug
- Retinopathy with surgical treatment during preceding three months of study entry or
requiring treatment within three months after study entry
- Drug abuse
- Hypersensitivity to insulin glagine excipients
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Type 2
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Intervention(s)
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Drug: Insulin Glargine
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Primary Outcome(s)
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12 - Item Well-Being Questionnaaire (WBQ12)
[Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.]
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Glycaemic controll will be asessed by HbA1c values
[Time Frame: week 12 and week 40]
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The fear of hypoglycaemia scale (HFS)
[Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.]
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Secondary Outcome(s)
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Incidence of symptomatic hypoglycemia and severe hypoglycemia
[Time Frame: sreening to follow-up phases]
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Secondary ID(s)
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Eudract #: 2005-000959-15
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HOE901_4057
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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