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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:	EUCTR
Last refreshed on:	7 August 2012
Main ID:	EUCTR2004-002036-25-LT
Date of registration:	27/07/2006
Prospective Registration:	Yes
Primary sponsor:	sanofi aventis groupe
Public title:	Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS
Scientific title:	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:	04/10/2006
Target sample size:	776
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002036-25
Study type:	Interventional clinical trial of medicinal product
Study design:	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
Phase:

Countries of recruitment
Belgium	Greece	Hungary	Italy	Lithuania	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

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-

Primary Outcome(s)

Primary end point(s): HbA1c

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.

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.

Secondary Outcome(s)

Secondary ID(s)

HMR1964A/3506

2004-002036-25-GB

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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