E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |