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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-IT
Date of registration:	24/10/2005
Prospective Registration:	No
Primary sponsor:	AVENTIS PHARMA S.P.A.
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 STUDY: Opposing Step-by-step Insulin Reinforcement to Intensified Strategy.
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 STUDY: Opposing Step-by-step Insulin Reinforcement to Intensified Strategy.
Date of first enrolment:	14/07/2005
Target sample size:
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: no Placebo: no Other: yes Other specify the comparator: Insulin glulisine + glargine + OADs
Phase:

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

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
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:

Age minimum:
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Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus.
MedDRA version: 6.1 Level: HLT Classification code 10012602

Intervention(s)

Trade Name: APIDRA
Pharmaceutical Form: Solution for injection
Current Sponsor code: HMR 1964
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 100-

Trade Name: LANTUS*SC 5CAR3ML100UI/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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Secondary Outcome(s)

Secondary ID(s)

2004-002036-25-GB

HMR 1964A/3506

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
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