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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000959-15-SE
Enrollment
Unknown
Registered
2005-03-21
Start date
2005-05-17
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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-

Sponsors

sanofi-aventis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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]): =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 ;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—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026