Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions
In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (ma...
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Veröffentlicht in: | Diabetes technology & therapeutics 2009-06, Vol.11 (6), p.379-383 |
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creator | Schöndorf, Thomas Karagiannis, Efstrathios Posseldt, Richard E K Forst, Thomas Pfützner, Andreas |
description | In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.
This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean +/- SD age was 60.8 +/- 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 +/- 4.7 years; body mass index [BMI], 31.0 +/- 5.2 kg/m(2)). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose [FBG]), blood pressure (BP), inflammation (high-sensitivity C-reactive protein [hsCRP]), and lipid metabolism (total cholesterol, high-density lipoprotein [HDL]-cholesterol, non-HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 +/- 15.1 vs. 134.4 +/- 12.0 mm Hg; diastolic BP, 83.1 +/- 8.9 vs. 80.5 +/- 7.5 mm Hg; HbA1c, 7.8 +/- 1.0% vs. 7.0 +/- 0.8%; FBG, 9.0 +/- 2.6 vs. 7.0 +/- 1.7 mM; cholesterol, 5.7 +/- 1.1 mM vs. 5.3 +/- 0.9 mM; HDL-cholesterol, 1.2 +/- 0.4 mM vs. 1.3 +/- 0.4 mM; non-HDL-cholesterol, 4.5 +/- 1.2 mM vs. 4.0 +/- 0.9 mM; triglycerides, 2.5 +/- 1.0 mM vs. 2.1 +/- 0.8 mM; hsCRP, 3.2 +/- 2.6 mg/L vs. 2.7 +/- 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 +/- 5.2 kg/m(2) vs. 31.1 +/- 6.1 kg/m(2), P = 0.221).
These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions. |
doi_str_mv | 10.1089/dia.2008.0108 |
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This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean +/- SD age was 60.8 +/- 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 +/- 4.7 years; body mass index [BMI], 31.0 +/- 5.2 kg/m(2)). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose [FBG]), blood pressure (BP), inflammation (high-sensitivity C-reactive protein [hsCRP]), and lipid metabolism (total cholesterol, high-density lipoprotein [HDL]-cholesterol, non-HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 +/- 15.1 vs. 134.4 +/- 12.0 mm Hg; diastolic BP, 83.1 +/- 8.9 vs. 80.5 +/- 7.5 mm Hg; HbA1c, 7.8 +/- 1.0% vs. 7.0 +/- 0.8%; FBG, 9.0 +/- 2.6 vs. 7.0 +/- 1.7 mM; cholesterol, 5.7 +/- 1.1 mM vs. 5.3 +/- 0.9 mM; HDL-cholesterol, 1.2 +/- 0.4 mM vs. 1.3 +/- 0.4 mM; non-HDL-cholesterol, 4.5 +/- 1.2 mM vs. 4.0 +/- 0.9 mM; triglycerides, 2.5 +/- 1.0 mM vs. 2.1 +/- 0.8 mM; hsCRP, 3.2 +/- 2.6 mg/L vs. 2.7 +/- 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 +/- 5.2 kg/m(2) vs. 31.1 +/- 6.1 kg/m(2), P = 0.221).
These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.</description><identifier>ISSN: 1520-9156</identifier><identifier>EISSN: 1557-8593</identifier><identifier>DOI: 10.1089/dia.2008.0108</identifier><identifier>PMID: 19459767</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Aged ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; C-Reactive Protein - drug effects ; C-Reactive Protein - metabolism ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Dosage and administration ; Drug therapy ; Drug Therapy, Combination ; Female ; Glycated Hemoglobin A - drug effects ; Glycated Hemoglobin A - metabolism ; Health aspects ; Humans ; Hypoglycemic Agents - therapeutic use ; Hypolipidemic Agents - therapeutic use ; Male ; Metformin ; Metformin - therapeutic use ; Middle Aged ; Patient outcomes ; Thiazolidinediones - therapeutic use ; Type 2 diabetes</subject><ispartof>Diabetes technology & therapeutics, 2009-06, Vol.11 (6), p.379-383</ispartof><rights>COPYRIGHT 2009 Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c358t-fc61d0a49e8a2e30dce894e9949b60a55a8b0b71eda832c4af79ead3f19982273</citedby><cites>FETCH-LOGICAL-c358t-fc61d0a49e8a2e30dce894e9949b60a55a8b0b71eda832c4af79ead3f19982273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19459767$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schöndorf, Thomas</creatorcontrib><creatorcontrib>Karagiannis, Efstrathios</creatorcontrib><creatorcontrib>Posseldt, Richard E K</creatorcontrib><creatorcontrib>Forst, Thomas</creatorcontrib><creatorcontrib>Pfützner, Andreas</creatorcontrib><title>Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions</title><title>Diabetes technology & therapeutics</title><addtitle>Diabetes Technol Ther</addtitle><description>In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.
This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean +/- SD age was 60.8 +/- 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 +/- 4.7 years; body mass index [BMI], 31.0 +/- 5.2 kg/m(2)). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose [FBG]), blood pressure (BP), inflammation (high-sensitivity C-reactive protein [hsCRP]), and lipid metabolism (total cholesterol, high-density lipoprotein [HDL]-cholesterol, non-HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 +/- 15.1 vs. 134.4 +/- 12.0 mm Hg; diastolic BP, 83.1 +/- 8.9 vs. 80.5 +/- 7.5 mm Hg; HbA1c, 7.8 +/- 1.0% vs. 7.0 +/- 0.8%; FBG, 9.0 +/- 2.6 vs. 7.0 +/- 1.7 mM; cholesterol, 5.7 +/- 1.1 mM vs. 5.3 +/- 0.9 mM; HDL-cholesterol, 1.2 +/- 0.4 mM vs. 1.3 +/- 0.4 mM; non-HDL-cholesterol, 4.5 +/- 1.2 mM vs. 4.0 +/- 0.9 mM; triglycerides, 2.5 +/- 1.0 mM vs. 2.1 +/- 0.8 mM; hsCRP, 3.2 +/- 2.6 mg/L vs. 2.7 +/- 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 +/- 5.2 kg/m(2) vs. 31.1 +/- 6.1 kg/m(2), P = 0.221).
These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.</description><subject>Aged</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>C-Reactive Protein - drug effects</subject><subject>C-Reactive Protein - metabolism</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Glycated Hemoglobin A - drug effects</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Hypolipidemic Agents - therapeutic use</subject><subject>Male</subject><subject>Metformin</subject><subject>Metformin - therapeutic use</subject><subject>Middle Aged</subject><subject>Patient outcomes</subject><subject>Thiazolidinediones - therapeutic use</subject><subject>Type 2 diabetes</subject><issn>1520-9156</issn><issn>1557-8593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptks-P1SAQxxujcdfVo1cziYmn7RNo-1qOmxd_JZt40XNDYXiiFCrQ1fqvexF8L9mYGA7A5POdGYZvVT2nZEfJwF8rI3aMkGFH8vVBdUm7rq-HjjcPy5mRmtNuf1E9ifErIaRvGH1cXVDedrzf95fV74OfF0xCpmsQoM1PVCD9PBknkvEOvIbF-KM1SfzyDkE4BTMm7cNs3DWYeQn-DmOJiclbI2EW4RuGCMZB2hYEBrnFCVOGlpwTXYrww6QvGYir1kaWEBztJnHOculdCt7CtN3XAWFz7boOGFeb5Tr4OXe7-Jjqv-WScUeIa7hDY61wEiEFIyysTmEAJYzdIPg1Y1gKKFPeFp9Wj7SwEZ-d96vq89s3nw7v69uP7z4cbm5r2XRDqrXcU0VEy3EQDBuiJA68Rc5bPu2J6DoxTGTqKSoxNEy2QvcchWo05XxgrG-uqlenvHlW31eMaZxNlFg6Rb_Gcd-zPn9el8GXJ_AoLI7GaZ-CkAUebxihjLKWlnS7_1B5qTLAPChtcvwfQX0SyOBjDKjHJZg8t22kZCwmGvMPjcVEYzFR5l-c-12nGdU9fXZN8wfsjsn8</recordid><startdate>200906</startdate><enddate>200906</enddate><creator>Schöndorf, Thomas</creator><creator>Karagiannis, Efstrathios</creator><creator>Posseldt, Richard E K</creator><creator>Forst, Thomas</creator><creator>Pfützner, Andreas</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200906</creationdate><title>Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions</title><author>Schöndorf, Thomas ; Karagiannis, Efstrathios ; Posseldt, Richard E K ; Forst, Thomas ; Pfützner, Andreas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c358t-fc61d0a49e8a2e30dce894e9949b60a55a8b0b71eda832c4af79ead3f19982273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>C-Reactive Protein - drug effects</topic><topic>C-Reactive Protein - metabolism</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Glycated Hemoglobin A - drug effects</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Hypolipidemic Agents - therapeutic use</topic><topic>Male</topic><topic>Metformin</topic><topic>Metformin - therapeutic use</topic><topic>Middle Aged</topic><topic>Patient outcomes</topic><topic>Thiazolidinediones - therapeutic use</topic><topic>Type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schöndorf, Thomas</creatorcontrib><creatorcontrib>Karagiannis, Efstrathios</creatorcontrib><creatorcontrib>Posseldt, Richard E K</creatorcontrib><creatorcontrib>Forst, Thomas</creatorcontrib><creatorcontrib>Pfützner, Andreas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes technology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schöndorf, Thomas</au><au>Karagiannis, Efstrathios</au><au>Posseldt, Richard E K</au><au>Forst, Thomas</au><au>Pfützner, Andreas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions</atitle><jtitle>Diabetes technology & therapeutics</jtitle><addtitle>Diabetes Technol Ther</addtitle><date>2009-06</date><risdate>2009</risdate><volume>11</volume><issue>6</issue><spage>379</spage><epage>383</epage><pages>379-383</pages><issn>1520-9156</issn><eissn>1557-8593</eissn><abstract>In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.
This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean +/- SD age was 60.8 +/- 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 +/- 4.7 years; body mass index [BMI], 31.0 +/- 5.2 kg/m(2)). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose [FBG]), blood pressure (BP), inflammation (high-sensitivity C-reactive protein [hsCRP]), and lipid metabolism (total cholesterol, high-density lipoprotein [HDL]-cholesterol, non-HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 +/- 15.1 vs. 134.4 +/- 12.0 mm Hg; diastolic BP, 83.1 +/- 8.9 vs. 80.5 +/- 7.5 mm Hg; HbA1c, 7.8 +/- 1.0% vs. 7.0 +/- 0.8%; FBG, 9.0 +/- 2.6 vs. 7.0 +/- 1.7 mM; cholesterol, 5.7 +/- 1.1 mM vs. 5.3 +/- 0.9 mM; HDL-cholesterol, 1.2 +/- 0.4 mM vs. 1.3 +/- 0.4 mM; non-HDL-cholesterol, 4.5 +/- 1.2 mM vs. 4.0 +/- 0.9 mM; triglycerides, 2.5 +/- 1.0 mM vs. 2.1 +/- 0.8 mM; hsCRP, 3.2 +/- 2.6 mg/L vs. 2.7 +/- 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 +/- 5.2 kg/m(2) vs. 31.1 +/- 6.1 kg/m(2), P = 0.221).
These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>19459767</pmid><doi>10.1089/dia.2008.0108</doi><tpages>5</tpages></addata></record> |
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subjects | Aged Blood Glucose - drug effects Blood Glucose - metabolism C-Reactive Protein - drug effects C-Reactive Protein - metabolism Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Dosage and administration Drug therapy Drug Therapy, Combination Female Glycated Hemoglobin A - drug effects Glycated Hemoglobin A - metabolism Health aspects Humans Hypoglycemic Agents - therapeutic use Hypolipidemic Agents - therapeutic use Male Metformin Metformin - therapeutic use Middle Aged Patient outcomes Thiazolidinediones - therapeutic use Type 2 diabetes |
title | Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions |
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