E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study population will consist of insufficiently controlled patients with type 2 diabetes with renal failure requiring dialysis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 |
This study will investigate the effect of pioglitazone vs. placebo treatment on insulin requirements and insulin resistance when given in addition to standard insulin care in patients with type 2 diabetes and kidney failure. Primary efficacy variable will be the total daily insulin dose |
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of pioglitazone vs. placebo when given in combination with insulin on several laboratory parameters of renal function, metabolic control, insulin resistance, vascular function, and macrovascular risk |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Type 2 diabetes mellitus 2. Age 30-80 years 3. BMI < 36 kg/m² 4. HbA1c > 6.5 % (HbA1c-values determined maximal 2 weeks prior to screening visit are acceptable to fulfil this inclusion criterion) 5. Patient is on hemo-dialysis with or without residual excretion 6. Insulin dose > 20 IE/day 7. Written informed consent |
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E.4 | Principal exclusion criteria |
1. History of type-1-diabetes 2. Acute infections 3. History of hypersensitivity to the study drugs or to drugs with similar chemical structures 4. History of severe or multiple allergies 5. Treatment with any other investigational drug within 3 months before trial entry. 6. Treatment with steroids within 3 months before trial entry. 7. Progressive fatal disease other than kidney failure 8. History of drug or alcohol abuse within the last 5 years 9. A history of significant cardiovascular (e.g. CHF NYHA stage III – IV), respiratory, gastrointestinal, hepatic (e.g. ALAT > 2.5 times the normal reference range), haematological disease 10. History of primary hyperaldosteronism 11. Pregnancy or breast feeding 12. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. 13. Treatment with thiazolidinediones within the past 3 months 14. Acute myocardial infarct, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable of the study is the change of the total daily insulin dose after 24 weeks of treatment (visit V7) as compared to baseline (visit V2) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | No |
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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Last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |