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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:	19 March 2012
Main ID:	EUCTR2005-000959-15-SE
Date of registration:	21/03/2005
Prospective Registration:	Yes
Primary sponsor:	sanofi-aventis
Public title:	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
Scientific title:	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
Date of first enrolment:	17/05/2005
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000959-15
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Sweden

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
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Key inclusion & exclusion criteria

Inclusion criteria:
•Patients with Type 2 diabetes inadequately controlled on a combination of highest tolerable dose of OAD + NPH insulin for more than 3 months
•HbA1c >7.0 %
•Age >18 years
•Willingness to participate
•Ability to perform QoL assessment
•Body Mass Index (BMI = weight [kg] / height [m] x height [m]): < or equal to 35 kg/m2
•Has been given written and verbal information and has had opportunity to ask questions about the study
•Signed consent (written) to participate in the study

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:
•Autoimmune diabetes, as defined by the World Health Organization (WHO)
•Ongoing treatment with tiazolidindion (TZD) drug
•Inability to comply with study procedures
•Retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding 3 months of study entry or requiring treatment within 3 months after the study entry
•Drug abuse
•Hypersensitivity to insulin glargine or any excipients

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

Health Condition(s) or Problem(s) studied

Patients with Type 2 diabetes inadequately controlled on a combination of highest tolerable dose of oral antidiabetic drugs (OAD) + neutral protamine hagedorn (NPH) insulin for more than 3 months

Intervention(s)

Product Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargin
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): •Diabetes Treatment Satisfaction Questionnaire (DTSQ)
•The fear of hypoglycaemia scale (HFS)
•12-Item Well-Being Questionnaire (WBQ12)
Glycaemic control will be assessed by HbA1c values

Incidence of symptomatic hypoglycemia and severe hypoglycemia

Main Objective: To assess QoL changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of OAD + NPH insulin treatment that are switched to insulin glargine.

Secondary Objective: To determine:
•change in HbA1c
•comparison of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine
•change in weight
•change in insulin dose

Secondary Outcome(s)

Secondary ID(s)

HOE901/4057

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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