The study population will consist of insufficiently controlled patients with type 2 diabetes with renal failure requiring dialysis MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Actos 30 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes mellitus 2. Age 30-80 years 3. BMI 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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) | — |
Countries
Germany
Outcome results
None listed