Diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Actos 15 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 2 2. HbA1c >= 6.5% = 25 6. 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 mellitus 2. Uncontrolled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >95mmHg), change of antihypertensive treatment within the last 2 weeks 3. Acute infections 4. NSAIDs (incl. low dose ASA) or Cox-2-inhibitors if therapy initiated within the last 4 weeks 5. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure 6. History of severe or multiple allergies 7. Treatment with any other investigational drug within 4 weeks before trial entry 8. History of drug or alcohol abuse in the past 5 years 9. A history of significant cardiovascular (NYHA stage I - IV; determined by anamnesis and clinical status), respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, GFR 5.5 mmol/L 13. History of primary hyperaldosteronism 14. Pregnancy or breast feeding 15. 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 16. Treatment with thiazolidinediones within the past 3 months 17. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous year 18. Any elective surgery during study participation 19. If statin therapy applicable: Change of medication within the last 4 weeks 20. Pre-treatment with gemfibrozil within the last 12 weeks 21. Pre-treatment with rifampicin within the last 12 weeks 22. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 months prior to screening visit 23. History of dehydration, precoma diabeticum or shock or diabetic ketoacidosis within the past year prior to screening visit 24. Acute or scheduled investigation with iodine containing radiopaque material 25. Uncontrolled unstable angina pectoris 26. Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm 27. Postmenopausal woman with present osteoporosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the effect of Pioglitazone in comparison to Metformin and the combination of both on MMP9 in patients with diabetes mellitus type 2 treated with insulin. ;Secondary Objective: Secondary objectives are • Circadian (7 point) blood glucose profile on 2 days in the week before V2.2, V4, and V6.2 • 24h blood pressure profile • IMT • Kidney function (24-hour urine, PGFa, albumin, creatinine, C/A-quotient) • NT-proBNP • HOMA S • Lipid profile (total cholesterol, LDL, HDL, triglycerides) • Metabolic markers (HbA1c, glucose, insulin, intact proinsulin, C-peptide, adiponectin, HMW adiponectin) • Inflammatory markers (hsCRP, fibrinogen, E-selectin, NF?B, PAI-1, nitrotyrosine) • Insulin consumption • Endothelial function measured by Laser-Doppler-Flowmetrie (O2C) • Laboratory safety variables including ALAT, ASAT,G-GT, GFR (Cockroft-Gault formula), AP, leucocytes, erythrocytes, haemoglobin, thrombocytes, CK, creatinine, capillary blood glucose, potassium • Side effects including body weight and ECG;Primary end point(s): Primary efficacy variable is the change of MMP9 after 6 months of treatment as compared to baseline. | — |
Countries
Austria, Germany
Outcome results
None listed