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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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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2004-002036-25-BE |
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Date of registration:
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27/07/2005 |
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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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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 |
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Date of first enrolment:
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14/07/2005 |
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Target sample size:
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776 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002036-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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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: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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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
- 7% < HbA1c £ 11%
- Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including a sulfonylurea (at a dosage ³ 50% of the maximum recommended 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 or glinides
- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
- Breast-feeding
- 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
- 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 as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
- Impaired renal function as shown by serum creatinine >135 µmol/l in men and > 110 µmol/l in women at study entry
- History of drug or alcohol abuse
Age minimum:
Age maximum:
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: 7.0
Level: LLT
Classification code 10012601
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Intervention(s)
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Trade Name: Apidra
Product Name: Apidra
Product Code: HMR1964
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glulisine
CAS Number: 207748-29-6
Current Sponsor code: HMR1964
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Lantus
Product Name: Lantus
Product Code: HOE901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
CAS Number: 160337-95-1
Current Sponsor code: HOE901
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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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 sulfonylurea 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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Primary end point(s): HbA1c
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Secondary ID(s)
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N/A
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2004-002036-25-GB
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HMR1964A/3506
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 14/07/2005
Contact:
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