A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes
A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes Fred Whitehouse , MD 1 , Davida F. Kruger , MSN 1 , Mark Fineman , BS 2 , Larry Shen , PHD 2 , James A. Ruggles , PHD 2 , David G. Maggs , MD 2 , Christian...
Gespeichert in:
| Veröffentlicht in: | Diabetes care 2002-04, Vol.25 (4), p.724-730 |
|---|---|
| Hauptverfasser: | , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 730 |
|---|---|
| container_issue | 4 |
| container_start_page | 724 |
| container_title | Diabetes care |
| container_volume | 25 |
| creator | WHITEHOUSE, Fred KRUGER, Davida F FINEMAN, Mark SHEN, Larry RUGGLES, James A MAGGS, David G WEYER, Christian KOLTERMAN, Orville G |
| description | A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy
in Type 1 Diabetes
Fred Whitehouse , MD 1 ,
Davida F. Kruger , MSN 1 ,
Mark Fineman , BS 2 ,
Larry Shen , PHD 2 ,
James A. Ruggles , PHD 2 ,
David G. Maggs , MD 2 ,
Christian Weyer , MD 2 and
Orville G. Kolterman , MD 2
1 Henry Ford Hospital, Detroit, Michigan
2 Amylin Pharmaceuticals, San Diego, California
Abstract
OBJECTIVE —To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients
with type 1 diabetes.
RESEARCH DESIGN AND METHODS —In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive
preprandial injections of placebo or 30 μg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated
patients were re-randomized to 30 or 60 μg pramlintide q.i.d. if decreases from baseline in HbA 1c were |
| doi_str_mv | 10.2337/diacare.25.4.724 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_223050136</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A85170987</galeid><sourcerecordid>A85170987</sourcerecordid><originalsourceid>FETCH-LOGICAL-c503t-27e505032dfd895efd621ce998f4078c927dfe9345ca8cea0af355b1e01cedf43</originalsourceid><addsrcrecordid>eNptklGLEzEQxxdRvLP67pMEQUFwa5LddJPHclY9KJxofQ5pMmlTdpOaZNX6KfzI5ujCgR7zkJnkN_-ZMFNVzwme06bp3hmntIowp2zezjvaPqguiWhYzVjLH1aXmLSiZkLQi-pJSgeMcdty_ri6IEQUa-hl9WeJvihvwuB-g0Ff82hOqMTo5gi-Xqst9Gj1K4NPLni0-qH6UWXndyjvAa2D39UbiANaWeu00icULPoc1dA7n50BpFIRQ0tzGL3OKAd07dNYHtFmD1EdT-jWPR0BEfTelWIZ0tPqkVV9gmfTOau-fVhtrj7V65uP11fLda0ZbnJNO2C4eNRYwwUDaxaUaBCC2xZ3XAvaGQuiaZlWXIPCyjaMbQngQhnbNrPq9Vn3GMP3EVKWg0sa-l55CGOSHVlgThekgC__AQ9hjL70JiltSg-kWRTo7RnaqR6k8zbkqPQOfPlmHzxYV66XnJEOC94VvL4HL2ZgcPo-Hp95HUNKEaw8RjeoeJIEy9tNkNMmSMpkK8smlJQXU9vjdgBzlzCNvgCvJkAlrXobldcu3XEN4y0v2rPqzZnbu93-pys1zDSq_4v-BSBYy7Y</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>223050136</pqid></control><display><type>article</type><title>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>WHITEHOUSE, Fred ; KRUGER, Davida F ; FINEMAN, Mark ; SHEN, Larry ; RUGGLES, James A ; MAGGS, David G ; WEYER, Christian ; KOLTERMAN, Orville G</creator><creatorcontrib>WHITEHOUSE, Fred ; KRUGER, Davida F ; FINEMAN, Mark ; SHEN, Larry ; RUGGLES, James A ; MAGGS, David G ; WEYER, Christian ; KOLTERMAN, Orville G</creatorcontrib><description>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy
in Type 1 Diabetes
Fred Whitehouse , MD 1 ,
Davida F. Kruger , MSN 1 ,
Mark Fineman , BS 2 ,
Larry Shen , PHD 2 ,
James A. Ruggles , PHD 2 ,
David G. Maggs , MD 2 ,
Christian Weyer , MD 2 and
Orville G. Kolterman , MD 2
1 Henry Ford Hospital, Detroit, Michigan
2 Amylin Pharmaceuticals, San Diego, California
Abstract
OBJECTIVE —To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients
with type 1 diabetes.
RESEARCH DESIGN AND METHODS —In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive
preprandial injections of placebo or 30 μg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated
patients were re-randomized to 30 or 60 μg pramlintide q.i.d. if decreases from baseline in HbA 1c were <1% at week 13. Of the 342 patients who completed the 52-week study, 236 individuals (∼70%) elected to participate in
a 1-year open-label extension in which all patients received 30 or 60 μg pramlintide q.i.d..
RESULTS —Treatment with pramlintide led to a mean reduction in HbA 1c of 0.67% from baseline to week 13 that was significantly ( P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained
through week 52 ( P = 0.0071). The greater HbA 1c reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall
event rate of severe hypoglycemia. In the open-label extension, mean HbA 1c levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients
who continued pramlintide treatment. The most common adverse events reported by the pramlintide group were mild nausea and
anorexia, which both occurred during the initial weeks of treatment and dissipated over time.
CONCLUSIONS —Mealtime pramlintide treatment as an adjunct to insulin improved long-term glycemic control without inducing weight gain
or increasing the overall risk of severe hypoglycemia in patients with type 1 diabetes.
DCCT, Diabetes Control and Complications Trial
ITT, intent to treat
Footnotes
Address correspondence and reprint requests to Orville G. Kolterman, MD, Amylin Pharmaceuticals, Inc., 9373 Towne Centre Dr.,
San Diego, CA 92121. E-mail: okolterman{at}amylin.com .
Received for publication 20 August 2001 and accepted in revised form 13 November 2001.
D.F.K., M.F., L.S., D.G.M., C.W., and O.G.K. hold stock in Amylin Pharmaceuticals. J.A.R. holds stock in Amylin Pharmaceuticals,
Bristol-Myers Squibb, and Schering Plough.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
DIABETES CARE</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/diacare.25.4.724</identifier><identifier>PMID: 11919132</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Adolescent ; Adult ; Aged ; Amyloid - adverse effects ; Amyloid - therapeutic use ; Biological and medical sciences ; Body Weight - drug effects ; Diabetes ; Diabetes Mellitus, Type 1 - blood ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes. Impaired glucose tolerance ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Evaluation ; Female ; Glucose metabolism ; Glycated Hemoglobin A - analysis ; Health aspects ; Hormones. Endocrine system ; Humans ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Incidence ; Insulin ; Insulin - adverse effects ; Insulin - therapeutic use ; Islet Amyloid Polypeptide ; Male ; Medical sciences ; Middle Aged ; Patient Compliance - statistics & numerical data ; Pharmacology. Drug treatments ; Placebos ; Product/service Evaluations ; Type 1 diabetes</subject><ispartof>Diabetes care, 2002-04, Vol.25 (4), p.724-730</ispartof><rights>2002 INIST-CNRS</rights><rights>COPYRIGHT 2002 American Diabetes Association</rights><rights>Copyright American Diabetes Association Apr 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-27e505032dfd895efd621ce998f4078c927dfe9345ca8cea0af355b1e01cedf43</citedby><cites>FETCH-LOGICAL-c503t-27e505032dfd895efd621ce998f4078c927dfe9345ca8cea0af355b1e01cedf43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13584823$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11919132$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>WHITEHOUSE, Fred</creatorcontrib><creatorcontrib>KRUGER, Davida F</creatorcontrib><creatorcontrib>FINEMAN, Mark</creatorcontrib><creatorcontrib>SHEN, Larry</creatorcontrib><creatorcontrib>RUGGLES, James A</creatorcontrib><creatorcontrib>MAGGS, David G</creatorcontrib><creatorcontrib>WEYER, Christian</creatorcontrib><creatorcontrib>KOLTERMAN, Orville G</creatorcontrib><title>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy
in Type 1 Diabetes
Fred Whitehouse , MD 1 ,
Davida F. Kruger , MSN 1 ,
Mark Fineman , BS 2 ,
Larry Shen , PHD 2 ,
James A. Ruggles , PHD 2 ,
David G. Maggs , MD 2 ,
Christian Weyer , MD 2 and
Orville G. Kolterman , MD 2
1 Henry Ford Hospital, Detroit, Michigan
2 Amylin Pharmaceuticals, San Diego, California
Abstract
OBJECTIVE —To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients
with type 1 diabetes.
RESEARCH DESIGN AND METHODS —In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive
preprandial injections of placebo or 30 μg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated
patients were re-randomized to 30 or 60 μg pramlintide q.i.d. if decreases from baseline in HbA 1c were <1% at week 13. Of the 342 patients who completed the 52-week study, 236 individuals (∼70%) elected to participate in
a 1-year open-label extension in which all patients received 30 or 60 μg pramlintide q.i.d..
RESULTS —Treatment with pramlintide led to a mean reduction in HbA 1c of 0.67% from baseline to week 13 that was significantly ( P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained
through week 52 ( P = 0.0071). The greater HbA 1c reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall
event rate of severe hypoglycemia. In the open-label extension, mean HbA 1c levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients
who continued pramlintide treatment. The most common adverse events reported by the pramlintide group were mild nausea and
anorexia, which both occurred during the initial weeks of treatment and dissipated over time.
CONCLUSIONS —Mealtime pramlintide treatment as an adjunct to insulin improved long-term glycemic control without inducing weight gain
or increasing the overall risk of severe hypoglycemia in patients with type 1 diabetes.
DCCT, Diabetes Control and Complications Trial
ITT, intent to treat
Footnotes
Address correspondence and reprint requests to Orville G. Kolterman, MD, Amylin Pharmaceuticals, Inc., 9373 Towne Centre Dr.,
San Diego, CA 92121. E-mail: okolterman{at}amylin.com .
Received for publication 20 August 2001 and accepted in revised form 13 November 2001.
D.F.K., M.F., L.S., D.G.M., C.W., and O.G.K. hold stock in Amylin Pharmaceuticals. J.A.R. holds stock in Amylin Pharmaceuticals,
Bristol-Myers Squibb, and Schering Plough.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
DIABETES CARE</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Amyloid - adverse effects</subject><subject>Amyloid - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Body Weight - drug effects</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1 - blood</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Evaluation</subject><subject>Female</subject><subject>Glucose metabolism</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Health aspects</subject><subject>Hormones. Endocrine system</subject><subject>Humans</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Incidence</subject><subject>Insulin</subject><subject>Insulin - adverse effects</subject><subject>Insulin - therapeutic use</subject><subject>Islet Amyloid Polypeptide</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Compliance - statistics & numerical data</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos</subject><subject>Product/service Evaluations</subject><subject>Type 1 diabetes</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptklGLEzEQxxdRvLP67pMEQUFwa5LddJPHclY9KJxofQ5pMmlTdpOaZNX6KfzI5ujCgR7zkJnkN_-ZMFNVzwme06bp3hmntIowp2zezjvaPqguiWhYzVjLH1aXmLSiZkLQi-pJSgeMcdty_ri6IEQUa-hl9WeJvihvwuB-g0Ff82hOqMTo5gi-Xqst9Gj1K4NPLni0-qH6UWXndyjvAa2D39UbiANaWeu00icULPoc1dA7n50BpFIRQ0tzGL3OKAd07dNYHtFmD1EdT-jWPR0BEfTelWIZ0tPqkVV9gmfTOau-fVhtrj7V65uP11fLda0ZbnJNO2C4eNRYwwUDaxaUaBCC2xZ3XAvaGQuiaZlWXIPCyjaMbQngQhnbNrPq9Vn3GMP3EVKWg0sa-l55CGOSHVlgThekgC__AQ9hjL70JiltSg-kWRTo7RnaqR6k8zbkqPQOfPlmHzxYV66XnJEOC94VvL4HL2ZgcPo-Hp95HUNKEaw8RjeoeJIEy9tNkNMmSMpkK8smlJQXU9vjdgBzlzCNvgCvJkAlrXobldcu3XEN4y0v2rPqzZnbu93-pys1zDSq_4v-BSBYy7Y</recordid><startdate>20020401</startdate><enddate>20020401</enddate><creator>WHITEHOUSE, Fred</creator><creator>KRUGER, Davida F</creator><creator>FINEMAN, Mark</creator><creator>SHEN, Larry</creator><creator>RUGGLES, James A</creator><creator>MAGGS, David G</creator><creator>WEYER, Christian</creator><creator>KOLTERMAN, Orville G</creator><general>American Diabetes Association</general><scope>IQODW</scope><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>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20020401</creationdate><title>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes</title><author>WHITEHOUSE, Fred ; KRUGER, Davida F ; FINEMAN, Mark ; SHEN, Larry ; RUGGLES, James A ; MAGGS, David G ; WEYER, Christian ; KOLTERMAN, Orville G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-27e505032dfd895efd621ce998f4078c927dfe9345ca8cea0af355b1e01cedf43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Amyloid - adverse effects</topic><topic>Amyloid - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Body Weight - drug effects</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 1 - blood</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Evaluation</topic><topic>Female</topic><topic>Glucose metabolism</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Health aspects</topic><topic>Hormones. Endocrine system</topic><topic>Humans</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Incidence</topic><topic>Insulin</topic><topic>Insulin - adverse effects</topic><topic>Insulin - therapeutic use</topic><topic>Islet Amyloid Polypeptide</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patient Compliance - statistics & numerical data</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos</topic><topic>Product/service Evaluations</topic><topic>Type 1 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>WHITEHOUSE, Fred</creatorcontrib><creatorcontrib>KRUGER, Davida F</creatorcontrib><creatorcontrib>FINEMAN, Mark</creatorcontrib><creatorcontrib>SHEN, Larry</creatorcontrib><creatorcontrib>RUGGLES, James A</creatorcontrib><creatorcontrib>MAGGS, David G</creatorcontrib><creatorcontrib>WEYER, Christian</creatorcontrib><creatorcontrib>KOLTERMAN, Orville G</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>WHITEHOUSE, Fred</au><au>KRUGER, Davida F</au><au>FINEMAN, Mark</au><au>SHEN, Larry</au><au>RUGGLES, James A</au><au>MAGGS, David G</au><au>WEYER, Christian</au><au>KOLTERMAN, Orville G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2002-04-01</date><risdate>2002</risdate><volume>25</volume><issue>4</issue><spage>724</spage><epage>730</epage><pages>724-730</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy
in Type 1 Diabetes
Fred Whitehouse , MD 1 ,
Davida F. Kruger , MSN 1 ,
Mark Fineman , BS 2 ,
Larry Shen , PHD 2 ,
James A. Ruggles , PHD 2 ,
David G. Maggs , MD 2 ,
Christian Weyer , MD 2 and
Orville G. Kolterman , MD 2
1 Henry Ford Hospital, Detroit, Michigan
2 Amylin Pharmaceuticals, San Diego, California
Abstract
OBJECTIVE —To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients
with type 1 diabetes.
RESEARCH DESIGN AND METHODS —In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive
preprandial injections of placebo or 30 μg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated
patients were re-randomized to 30 or 60 μg pramlintide q.i.d. if decreases from baseline in HbA 1c were <1% at week 13. Of the 342 patients who completed the 52-week study, 236 individuals (∼70%) elected to participate in
a 1-year open-label extension in which all patients received 30 or 60 μg pramlintide q.i.d..
RESULTS —Treatment with pramlintide led to a mean reduction in HbA 1c of 0.67% from baseline to week 13 that was significantly ( P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained
through week 52 ( P = 0.0071). The greater HbA 1c reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall
event rate of severe hypoglycemia. In the open-label extension, mean HbA 1c levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients
who continued pramlintide treatment. The most common adverse events reported by the pramlintide group were mild nausea and
anorexia, which both occurred during the initial weeks of treatment and dissipated over time.
CONCLUSIONS —Mealtime pramlintide treatment as an adjunct to insulin improved long-term glycemic control without inducing weight gain
or increasing the overall risk of severe hypoglycemia in patients with type 1 diabetes.
DCCT, Diabetes Control and Complications Trial
ITT, intent to treat
Footnotes
Address correspondence and reprint requests to Orville G. Kolterman, MD, Amylin Pharmaceuticals, Inc., 9373 Towne Centre Dr.,
San Diego, CA 92121. E-mail: okolterman{at}amylin.com .
Received for publication 20 August 2001 and accepted in revised form 13 November 2001.
D.F.K., M.F., L.S., D.G.M., C.W., and O.G.K. hold stock in Amylin Pharmaceuticals. J.A.R. holds stock in Amylin Pharmaceuticals,
Bristol-Myers Squibb, and Schering Plough.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
DIABETES CARE</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>11919132</pmid><doi>10.2337/diacare.25.4.724</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-5992 |
| ispartof | Diabetes care, 2002-04, Vol.25 (4), p.724-730 |
| issn | 0149-5992 1935-5548 |
| language | eng |
| recordid | cdi_proquest_journals_223050136 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adolescent Adult Aged Amyloid - adverse effects Amyloid - therapeutic use Biological and medical sciences Body Weight - drug effects Diabetes Diabetes Mellitus, Type 1 - blood Diabetes Mellitus, Type 1 - drug therapy Diabetes. Impaired glucose tolerance Dose-Response Relationship, Drug Double-Blind Method Drug therapy Drug Therapy, Combination Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Evaluation Female Glucose metabolism Glycated Hemoglobin A - analysis Health aspects Hormones. Endocrine system Humans Hypoglycemia - epidemiology Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Incidence Insulin Insulin - adverse effects Insulin - therapeutic use Islet Amyloid Polypeptide Male Medical sciences Middle Aged Patient Compliance - statistics & numerical data Pharmacology. Drug treatments Placebos Product/service Evaluations Type 1 diabetes |
| title | A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-31T17%3A45%3A21IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Randomized%20Study%20and%20Open-Label%20Extension%20Evaluating%20the%20Long-Term%20Efficacy%20of%20Pramlintide%20as%20an%20Adjunct%20to%20Insulin%20Therapy%20in%20Type%201%20Diabetes&rft.jtitle=Diabetes%20care&rft.au=WHITEHOUSE,%20Fred&rft.date=2002-04-01&rft.volume=25&rft.issue=4&rft.spage=724&rft.epage=730&rft.pages=724-730&rft.issn=0149-5992&rft.eissn=1935-5548&rft.coden=DICAD2&rft_id=info:doi/10.2337/diacare.25.4.724&rft_dat=%3Cgale_proqu%3EA85170987%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=223050136&rft_id=info:pmid/11919132&rft_galeid=A85170987&rfr_iscdi=true |