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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. |
Register:
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EUCTR |
Last refreshed on:
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29 October 2012 |
Main ID: |
EUCTR2004-002036-25-SE |
Date of registration:
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30/01/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS
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Scientific title:
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Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS |
Date of first enrolment:
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28/03/2006 |
Target sample size:
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776 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002036-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Greece
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Hungary
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Italy
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Lithuania
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: - Type 2 diabetic men or women - Aged 18 to 75 years - BMI =40 kg/m2 - HbA1c > 7% - Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at any dosage) and metformin (at the maximum tolerated dosage), for more than 6 months
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Type 1 diabetes mellitus - Treatment with OADs only - Treatment with thiazolidinediones - Treatment with an insulin other than basal insulin - Active proliferative diabetic retinopathy - Pregnancy - Breast-feeding - History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine - Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration - Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine - Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2) - Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult - Impaired hepatic function at study entry - Impaired renal function at study entry
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes mellitus MedDRA version: 8.1
Level: LLT
Classification code 10045242
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Intervention(s)
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Trade Name: Apidra 100 U/ml, solution for injection in cartridge Product Name: Apidra 100 U/ml, solution for injection in cartridge Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin glulisine Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: Lantus 100U/ml, solution for injection in a cartridge Product Name: Lantus 100 U/ml, solution for injection in a cartridge Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin glargine Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): HbA1c
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Secondary Objective: To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c = 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.
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Main Objective: To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
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Secondary ID(s)
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HMR1964A/3506
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2004-002036-25-GB
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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