Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7348
Source ID: NCT00770653
Associated Drug: Pioglitazone And Metformin
Title: Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00770653/results
Conditions: Diabetes Mellitus|Dyslipidemias
Interventions: DRUG: Pioglitazone and Metformin|DRUG: Glimepiride and Metformin
Outcome Measures: Primary: The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol., The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline., Baseline and Week 24. | Secondary: Change From Baseline in High-Density Lipoprotein Cholesterol., The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline., Baseline and Week 24.|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio., The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline., Baseline and Week 24.|Change From Baseline in Triglycerides., The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline., Baseline and Week 24.|Change From Baseline in Low-Density Lipoprotein Subfractions., The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline., Baseline and Week 24.|Change From Baseline in Low-Density Lipoprotein Cholesterol., The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline., Baseline and Week 24.|Change From Baseline in Glycosylated Hemoglobin., The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline., Baseline and Week 24.|Change From Baseline in Fasting Intact Proinsulin., The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline., Baseline and Week 24.|Change From Baseline in Fasting Glucose., The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline., Baseline and Week 24.|Change From Baseline in Adiponectin., The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline., Baseline and Week 24.|Change From Baseline in High Sensitivity C-reactive Protein (Original)., The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline., Baseline and Week 24.|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L)., The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline., Baseline and Week 24.|Change From Baseline in Systolic Blood Pressure., The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline., Baseline and Week 24.|Change From Baseline in Diastolic Blood Pressure., The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline., Baseline and Week 24.|Intake of Study Medication Greater Than 80% and Less Than 120%., The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline., Baseline and Week 24.|Change From Baseline in Nitrotyrosine., The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline., Baseline and Week 24.|Change From Baseline in Soluble CD40 Ligand., The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline., Baseline and Week 24.|Change From Baseline in Matrix Metallo Proteinase-9., The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline., Baseline and Week 24.|Change From Baseline in Soluble Intracellular Adhesion Molecule., The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline., Baseline and Week 24.|Change From Baseline in Soluble Vascular Cell Adhesion Molecule., The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline., Baseline and Week 24.|Change From Baseline in Thromboxane B2., The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline., Baseline and Week 24.|Change From Baseline in Platelet Function., The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline., Baseline and Week 24.|Change From Baseline in E-Selectin., The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline., Baseline and Week 24.|Change From Baseline in Von-Willebrand Factor., The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (0.30%)., The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (0.60%), The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (1.20)., The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (3.00)., The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (6.00)., The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (12.00)., The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (30.00)., The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.|Change From Baseline in Erythrocyte Deformability (60.00)., The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline., Baseline and Week 24.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 305
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-04
Completion Date: 2009-05
Results First Posted: 2010-10-06
Last Update Posted: 2010-10-06
Locations: Bretten, Baden-Württemberg, Germany|Deggingen, Baden-Württemberg, Germany|Dettenheim, Baden-Württemberg, Germany|Künzelsau, Baden-Württemberg, Germany|Rottweil, Baden-Württemberg, Germany|Spaichingen, Baden-Württemberg, Germany|Stockach, Baden-Württemberg, Germany|Wangen, Baden-Württemberg, Germany|Augsburg, Bayern, Germany|Feldafing, Bayern, Germany|Furth im Wald, Bayern, Germany|Immenstadt, Bayern, Germany|Lichtenfels, Bayern, Germany|München, Bayern, Germany|Schweinfurt, Bayern, Germany|Waldkraiburg, Bayern, Germany|Wallerfing, Bayern, Germany|Weilersbach, Bayern, Germany|Würzburg, Bayern, Germany|Ketzin, Brandenburg, Germany|Rüdersdorf, Brandenburg, Germany|Bermerhaven, Bremen, Germany|Bensheim, Hessen, Germany|Ehrenberg, Hessen, Germany|Gersfeld, Hessen, Germany|Kassel, Hessen, Germany|Kelkheim, Hessen, Germany|Offenbach, Hessen, Germany|Schwerin, Mecklenburg-Vorpommern, Germany|Celle, Niedersachsen, Germany|Einbeck, Niedersachsen, Germany|Hannover, Niedersachsen, Germany|Hildesheim, Niedersachsen, Germany|Bad Berleburg, Nordrhein-Westfalen, Germany|Bad Laasphe, Nordrhein-Westfalen, Germany|Bad Oeynhausen, Nordrhein-Westfalen, Germany|Bocholt, Nordrhein-Westfalen, Germany|Dinslaken, Nordrhein-Westfalen, Germany|Dorsten, Nordrhein-Westfalen, Germany|Duisburg, Nordrhein-Westfalen, Germany|Essen, Nordrhein-Westfalen, Germany|Frechen, Nordrhein-Westfalen, Germany|Isselburg, Nordrhein-Westfalen, Germany|Kamen, Nordrhein-Westfalen, Germany|Köln, Nordrhein-Westfalen, Germany|Marl, Nordrhein-Westfalen, Germany|Menden, Nordrhein-Westfalen, Germany|Münster, Nordrhein-Westfalen, Germany|Siegen, Nordrhein-Westfalen, Germany|Diez, Rheinland-Pfalz, Germany|Mainz, Rheinland-Pfalz, Germany|Neuwied, Rheinland-Pfalz, Germany|Rodenbach, Rheinland-Pfalz, Germany|Simmern, Rheinland-Pfalz, Germany|Magdeburg, Sachsen-Anhalt, Germany|Borna, Sachsen, Germany|Dresden, Sachsen, Germany|Meißen, Sachsen, Germany|Mittweida, Sachsen, Germany|Reinfeld, Schleswig-Holstein, Germany|Altenburg, Thüringen, Germany|Blankenhain, Thüringen, Germany|Berlin, Germany|Hamburg, Germany
URL: https://clinicaltrials.gov/show/NCT00770653