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Sponsored by: |
Takeda Pharma GmbH |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00770445 |
The purpose of this study is to determine the Anti-Inflammation Effects of Pioglitazone and Pioglitazone/Metformin Combination Therapy in Type 2 Diabetes Subjects Treated with Insulin.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: Pioglitazone and insulin Drug: Pioglitazone and metformin and insulin Drug: Metformin and insulin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact of Pioglitazone, Metformin and the Combination of Both on Cardiovascular Risk in Insulin-Treated Patients With Type 2 Diabetes - The PIOcomb Study |
Estimated Enrollment: | 132 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Pioglitazone and insulin
Pioglitazone 15 mg, tablets, orally, twice daily and metformin placebo-matching tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
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2: Experimental |
Drug: Pioglitazone and metformin and insulin
Pioglitazone 15 mg, tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
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3: Active Comparator |
Drug: Metformin and insulin
Pioglitazone placebo-matching tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
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It is established that matrix metalloproteinases play an essential role in the degradation of collagen and other extra cellular matrix macromolecules. In addition, matrix metalloproteinases are implicated in plaque rupture through their capacity to thin the protective cap of the plaque, thus rendering it more vulnerable. In fact, matrix metalloproteinase-9 levels are elevated in patients with unstable plaques and in patients with acute coronary syndrome. In patients with type 2 diabetes mellitus, matrix metalloproteinase-1 and matrix metalloproteinase-9 levels are usually elevated and the atherosclerotic plaques are more vulnerable compared to non-diabetic patients, confirming the role of this proteinase in the development of acute coronary syndrome. Therefore, therapeutic strategies that reduce blood glucose levels and attenuate inflammation and matrix metalloproteinases activity may be a tool for reducing cardiovascular risk in patients with diabetes.
The purpose of this trial is to investigate whether the anti-inflammatory effects of pioglitazone are maintained and sustained over a longer observation period when given in combination with insulin in comparison to the metformin plus insulin combination.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Contact: Study Manager | +49 800 8253325 |
Germany | |
Recruiting | |
Hamburg, Germany | |
Germany, Hessen | |
Recruiting | |
Kassel, Hessen, Germany | |
Recruiting | |
Wiesbaden, Hessen, Germany | |
Recruiting | |
Frankfurt, Hessen, Germany | |
Germany, Nordrhein-Westfalen | |
Recruiting | |
Wuppertal, Nordrhein-Westfalen, Germany | |
Germany, Rheinland-Pfalz | |
Recruiting | |
Mainz, Rheinland-Pfalz, Germany | |
Germany, Thüringen | |
Recruiting | |
Jena, Thüringen, Germany |
Study Director: | Medical Director | Takeda Pharma GmbH |
Responsible Party: | Takeda Pharma GmbH, Aachen (Germany) ( Medical Director ) |
Study ID Numbers: | ATS K028, 2007-006706-14, DE-PIO-028 |
Study First Received: | October 9, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00770445 |
Health Authority: | European Union: European Medicines Agency |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes |
Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy |
Metabolic Diseases Pioglitazone Metformin Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin Dyslipidemias |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |