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A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes
Aim This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes. Methods Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to r...
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| Published in: | Diabetes, obesity & metabolism obesity & metabolism, 2013-08, Vol.15 (8), p.721-728 |
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| container_title | Diabetes, obesity & metabolism |
| container_volume | 15 |
| creator | Ferrannini, E. Seman, L. Seewaldt-Becker, E. Hantel, S. Pinnetti, S. Woerle, H. J. |
| description | Aim
This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
Methods
Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.
Results
After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p |
| doi_str_mv | 10.1111/dom.12081 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_1373437753</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1373437753</sourcerecordid><originalsourceid>FETCH-LOGICAL-i3171-b5763d907ccd67ee412e97541b3cfb946c9bb9dbb5cedb10e4bdd5ad704cdedf3</originalsourceid><addsrcrecordid>eNpdkU1v1DAQhi0EoqVw4A8gS1w4NK2_Em-OpaXLiqUfosDRsuMJ6-LEaexo2f563N3SA3OZ0czzvhrNIPSWkiOa49iG7ogyMqPP0D4VFS8oZ9Xzbc2KWU3YHnoV4y0hRPCZfIn2GOf1rORkH61P8NVKR8CLhTnEo-6zl7sHe4gHrxswoWhCn8bgPVgc02Q3OLQ4rQB_my9vGHb9yhmXwoihG_Qv71of7l2f-3jQyUGfIl67tMJpMwBm2DptIEF8jV602kd485gP0PfzTzenn4vl5XxxerIsHKeSFqaUFbc1kU1jKwkgKINaloIa3rSmFlVTG1NbY8oGrKEEhLG21FYS0ViwLT9AH3a-wxjuJohJdS424L3uIUxRUS654FKWPKPv_0NvwzT2ebsHipWSUCEz9e6RmkwHVg2j6_S4Uf9OmoHjHbB2HjZPc0rUw69Uvq_a_kqdXX7dFllR7BQuJvjzpNDjb1VJLkv182Ku5PUXzi_OP6of_C9GnJW8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1372570147</pqid></control><display><type>article</type><title>A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes</title><source>Wiley</source><creator>Ferrannini, E. ; Seman, L. ; Seewaldt-Becker, E. ; Hantel, S. ; Pinnetti, S. ; Woerle, H. J.</creator><creatorcontrib>Ferrannini, E. ; Seman, L. ; Seewaldt-Becker, E. ; Hantel, S. ; Pinnetti, S. ; Woerle, H. J.</creatorcontrib><description>Aim
This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
Methods
Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.
Results
After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: −1.29 mmol/l, 10 mg: −1.61 mmol/l, 25 mg: −1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation.
Conclusions
In patients with type 2 diabetes, empagliflozin resulted in dose‐dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well‐tolerated with a favourable safety profile.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.12081</identifier><identifier>PMID: 23398530</identifier><identifier>CODEN: DOMEF6</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Argentina - epidemiology ; Benzhydryl Compounds - administration & dosage ; Benzhydryl Compounds - adverse effects ; BI 10773 ; Blood Glucose ; Body Weight ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; empagliflozin ; Europe - epidemiology ; Female ; FPG ; Glucosides - administration & dosage ; Glucosides - adverse effects ; Glycated Hemoglobin A - metabolism ; HbA1c ; Humans ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Male ; Metformin - administration & dosage ; Middle Aged ; Nasopharyngitis - chemically induced ; Nasopharyngitis - epidemiology ; Republic of Korea - epidemiology ; Russia - epidemiology ; SGLT2 inhibitor ; Sodium-Glucose Transporter 2 - antagonists & inhibitors ; Taiwan - epidemiology ; Thirst ; tolerability ; Treatment Outcome ; Ukraine - epidemiology ; Urination Disorders - chemically induced ; Urination Disorders - epidemiology ; Weight Loss</subject><ispartof>Diabetes, obesity & metabolism, 2013-08, Vol.15 (8), p.721-728</ispartof><rights>2013 Blackwell Publishing Ltd</rights><rights>2013 Blackwell Publishing Ltd.</rights><rights>2013 John Wiley & Sons Ltd</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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/23398530$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ferrannini, E.</creatorcontrib><creatorcontrib>Seman, L.</creatorcontrib><creatorcontrib>Seewaldt-Becker, E.</creatorcontrib><creatorcontrib>Hantel, S.</creatorcontrib><creatorcontrib>Pinnetti, S.</creatorcontrib><creatorcontrib>Woerle, H. J.</creatorcontrib><title>A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim
This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
Methods
Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.
Results
After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: −1.29 mmol/l, 10 mg: −1.61 mmol/l, 25 mg: −1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation.
Conclusions
In patients with type 2 diabetes, empagliflozin resulted in dose‐dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well‐tolerated with a favourable safety profile.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Argentina - epidemiology</subject><subject>Benzhydryl Compounds - administration & dosage</subject><subject>Benzhydryl Compounds - adverse effects</subject><subject>BI 10773</subject><subject>Blood Glucose</subject><subject>Body Weight</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - epidemiology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>empagliflozin</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>FPG</subject><subject>Glucosides - administration & dosage</subject><subject>Glucosides - adverse effects</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>HbA1c</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Male</subject><subject>Metformin - administration & dosage</subject><subject>Middle Aged</subject><subject>Nasopharyngitis - chemically induced</subject><subject>Nasopharyngitis - epidemiology</subject><subject>Republic of Korea - epidemiology</subject><subject>Russia - epidemiology</subject><subject>SGLT2 inhibitor</subject><subject>Sodium-Glucose Transporter 2 - antagonists & inhibitors</subject><subject>Taiwan - epidemiology</subject><subject>Thirst</subject><subject>tolerability</subject><subject>Treatment Outcome</subject><subject>Ukraine - epidemiology</subject><subject>Urination Disorders - chemically induced</subject><subject>Urination Disorders - epidemiology</subject><subject>Weight Loss</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNpdkU1v1DAQhi0EoqVw4A8gS1w4NK2_Em-OpaXLiqUfosDRsuMJ6-LEaexo2f563N3SA3OZ0czzvhrNIPSWkiOa49iG7ogyMqPP0D4VFS8oZ9Xzbc2KWU3YHnoV4y0hRPCZfIn2GOf1rORkH61P8NVKR8CLhTnEo-6zl7sHe4gHrxswoWhCn8bgPVgc02Q3OLQ4rQB_my9vGHb9yhmXwoihG_Qv71of7l2f-3jQyUGfIl67tMJpMwBm2DptIEF8jV602kd485gP0PfzTzenn4vl5XxxerIsHKeSFqaUFbc1kU1jKwkgKINaloIa3rSmFlVTG1NbY8oGrKEEhLG21FYS0ViwLT9AH3a-wxjuJohJdS424L3uIUxRUS654FKWPKPv_0NvwzT2ebsHipWSUCEz9e6RmkwHVg2j6_S4Uf9OmoHjHbB2HjZPc0rUw69Uvq_a_kqdXX7dFllR7BQuJvjzpNDjb1VJLkv182Ku5PUXzi_OP6of_C9GnJW8</recordid><startdate>201308</startdate><enddate>201308</enddate><creator>Ferrannini, E.</creator><creator>Seman, L.</creator><creator>Seewaldt-Becker, E.</creator><creator>Hantel, S.</creator><creator>Pinnetti, S.</creator><creator>Woerle, H. J.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201308</creationdate><title>A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes</title><author>Ferrannini, E. ; Seman, L. ; Seewaldt-Becker, E. ; Hantel, S. ; Pinnetti, S. ; Woerle, H. J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i3171-b5763d907ccd67ee412e97541b3cfb946c9bb9dbb5cedb10e4bdd5ad704cdedf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Argentina - epidemiology</topic><topic>Benzhydryl Compounds - administration & dosage</topic><topic>Benzhydryl Compounds - adverse effects</topic><topic>BI 10773</topic><topic>Blood Glucose</topic><topic>Body Weight</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - epidemiology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>empagliflozin</topic><topic>Europe - epidemiology</topic><topic>Female</topic><topic>FPG</topic><topic>Glucosides - administration & dosage</topic><topic>Glucosides - adverse effects</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>HbA1c</topic><topic>Humans</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Male</topic><topic>Metformin - administration & dosage</topic><topic>Middle Aged</topic><topic>Nasopharyngitis - chemically induced</topic><topic>Nasopharyngitis - epidemiology</topic><topic>Republic of Korea - epidemiology</topic><topic>Russia - epidemiology</topic><topic>SGLT2 inhibitor</topic><topic>Sodium-Glucose Transporter 2 - antagonists & inhibitors</topic><topic>Taiwan - epidemiology</topic><topic>Thirst</topic><topic>tolerability</topic><topic>Treatment Outcome</topic><topic>Ukraine - epidemiology</topic><topic>Urination Disorders - chemically induced</topic><topic>Urination Disorders - epidemiology</topic><topic>Weight Loss</topic><toplevel>online_resources</toplevel><creatorcontrib>Ferrannini, E.</creatorcontrib><creatorcontrib>Seman, L.</creatorcontrib><creatorcontrib>Seewaldt-Becker, E.</creatorcontrib><creatorcontrib>Hantel, S.</creatorcontrib><creatorcontrib>Pinnetti, S.</creatorcontrib><creatorcontrib>Woerle, H. J.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ferrannini, E.</au><au>Seman, L.</au><au>Seewaldt-Becker, E.</au><au>Hantel, S.</au><au>Pinnetti, S.</au><au>Woerle, H. J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2013-08</date><risdate>2013</risdate><volume>15</volume><issue>8</issue><spage>721</spage><epage>728</epage><pages>721-728</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><coden>DOMEF6</coden><abstract>Aim
This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
Methods
Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.
Results
After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: −1.29 mmol/l, 10 mg: −1.61 mmol/l, 25 mg: −1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation.
Conclusions
In patients with type 2 diabetes, empagliflozin resulted in dose‐dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well‐tolerated with a favourable safety profile.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>23398530</pmid><doi>10.1111/dom.12081</doi><tpages>8</tpages></addata></record> |
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| ispartof | Diabetes, obesity & metabolism, 2013-08, Vol.15 (8), p.721-728 |
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| subjects | Adult Aged Aged, 80 and over Argentina - epidemiology Benzhydryl Compounds - administration & dosage Benzhydryl Compounds - adverse effects BI 10773 Blood Glucose Body Weight Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - epidemiology Dose-Response Relationship, Drug Double-Blind Method Drug Therapy, Combination empagliflozin Europe - epidemiology Female FPG Glucosides - administration & dosage Glucosides - adverse effects Glycated Hemoglobin A - metabolism HbA1c Humans Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Male Metformin - administration & dosage Middle Aged Nasopharyngitis - chemically induced Nasopharyngitis - epidemiology Republic of Korea - epidemiology Russia - epidemiology SGLT2 inhibitor Sodium-Glucose Transporter 2 - antagonists & inhibitors Taiwan - epidemiology Thirst tolerability Treatment Outcome Ukraine - epidemiology Urination Disorders - chemically induced Urination Disorders - epidemiology Weight Loss |
| title | A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes |
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