197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D

ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 d...

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Veröffentlicht in:	Diabetes (New York, N.Y.) N.Y.), 2021-06, Vol.70 (Supplement_1)
Hauptverfasser:	MEIFFREN, GRÉGORY, ANDERSEN, GRIT, ELOY, ROSY, MÉGRET, CLAIRE, FAMULLA, SUSANNE, SEROUSSI, CYRIL, CHAN, YOU-PING, GAUDIER, MARTIN, SOULA, OLIVIER, DEVRIES, J. HANS, HEISE, TIM
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Sprache:	eng
Schlagworte:	Acetaminophen Appetite loss Blood glucose Body weight Diabetes Gastric emptying Glucagon Glucose Hypoglycemia Insulin Nausea
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creator	MEIFFREN, GRÉGORY ANDERSEN, GRIT ELOY, ROSY MÉGRET, CLAIRE FAMULLA, SUSANNE SEROUSSI, CYRIL CHAN, YOU-PING GAUDIER, MARTIN SOULA, OLIVIER DEVRIES, J. HANS HEISE, TIM
description	ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time
doi_str_mv	10.2337/db21-197-OR
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HANS ; HEISE, TIM</creator><creatorcontrib>MEIFFREN, GRÉGORY ; ANDERSEN, GRIT ; ELOY, ROSY ; MÉGRET, CLAIRE ; FAMULLA, SUSANNE ; SEROUSSI, CYRIL ; CHAN, YOU-PING ; GAUDIER, MARTIN ; SOULA, OLIVIER ; DEVRIES, J. HANS ; HEISE, TIM</creatorcontrib><description>ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p<0.001) vs. ASP (figure). Post-meal glucagon levels were lowered by up to 85% and speed of gastric emptying (acetaminophen absorption) reduced by >50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time <70 mg/dL (+13mins) with ADO09. Body weight decreased by 1.6 kg with ADO09 (p=0.007) as did daily prandial insulin doses (-12 U vs. ASP, median 35.0 U vs. 47.3; p=0.0004). Slightly more hypoglycemic episodes were noted with ADO09 (n=96 vs. 79) with no difference in nocturnal hypoglycemia. While more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite). 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HANS</creatorcontrib><creatorcontrib>HEISE, TIM</creatorcontrib><title>197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D</title><title>Diabetes (New York, N.Y.)</title><description>ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p<0.001) vs. ASP (figure). Post-meal glucagon levels were lowered by up to 85% and speed of gastric emptying (acetaminophen absorption) reduced by >50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time <70 mg/dL (+13mins) with ADO09. Body weight decreased by 1.6 kg with ADO09 (p=0.007) as did daily prandial insulin doses (-12 U vs. ASP, median 35.0 U vs. 47.3; p=0.0004). Slightly more hypoglycemic episodes were noted with ADO09 (n=96 vs. 79) with no difference in nocturnal hypoglycemia. While more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite). In conclusion, ADO09 improved blood glucose control and reduced both body weight and prandial insulin doses vs. insulin aspart in T1D subjects with high prandial insulin needs.</description><subject>Acetaminophen</subject><subject>Appetite loss</subject><subject>Blood glucose</subject><subject>Body weight</subject><subject>Diabetes</subject><subject>Gastric emptying</subject><subject>Glucagon</subject><subject>Glucose</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Nausea</subject><issn>0012-1797</issn><issn>1939-327X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNotkN9KwzAUxoMoOKdXvkDAG8VV86dtGu_mpnMwqMyJ3oW0SVxH28ykVfYaPrGtk3NxOIff-b7DB8A5RjeEUnarMoIDzFmQLg_AAHPKA0rY-yEYIIRJgBlnx-DE-w1CKO5qAH729B0cT1PER1DCiTXWVW0pm8LW0Bo4r31bFjUcEzyDslbw2cmqWzSF0vCyH65GcF5tnf3SHt6X1io4K9vcet2J1Y2z5d_ZUqs27wmrdvBNFx_rBnayL2220Xnj4XfRrOEKT0_BkZGl12f_fQheHx9Wk6dgkc7mk_EiyDGKw4CiSPEwC5XhoWKKxRJrxiSmRHJOcsoSQgxJTJyxKDJZxAlLcJYgHFGSxxrTIbjY63aff7baN2JjW1d3loJEMSExQyzsqOs9lTvrvdNGbF1RSbcTGIk-dNGHLroYRbqkv-W8cW4</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>MEIFFREN, GRÉGORY</creator><creator>ANDERSEN, GRIT</creator><creator>ELOY, ROSY</creator><creator>MÉGRET, CLAIRE</creator><creator>FAMULLA, SUSANNE</creator><creator>SEROUSSI, CYRIL</creator><creator>CHAN, YOU-PING</creator><creator>GAUDIER, MARTIN</creator><creator>SOULA, OLIVIER</creator><creator>DEVRIES, J. HANS</creator><creator>HEISE, TIM</creator><general>American Diabetes Association</general><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20210601</creationdate><title>197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D</title><author>MEIFFREN, GRÉGORY ; ANDERSEN, GRIT ; ELOY, ROSY ; MÉGRET, CLAIRE ; FAMULLA, SUSANNE ; SEROUSSI, CYRIL ; CHAN, YOU-PING ; GAUDIER, MARTIN ; SOULA, OLIVIER ; DEVRIES, J. 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HANS</creatorcontrib><creatorcontrib>HEISE, TIM</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Diabetes (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MEIFFREN, GRÉGORY</au><au>ANDERSEN, GRIT</au><au>ELOY, ROSY</au><au>MÉGRET, CLAIRE</au><au>FAMULLA, SUSANNE</au><au>SEROUSSI, CYRIL</au><au>CHAN, YOU-PING</au><au>GAUDIER, MARTIN</au><au>SOULA, OLIVIER</au><au>DEVRIES, J. HANS</au><au>HEISE, TIM</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D</atitle><jtitle>Diabetes (New York, N.Y.)</jtitle><date>2021-06-01</date><risdate>2021</risdate><volume>70</volume><issue>Supplement_1</issue><issn>0012-1797</issn><eissn>1939-327X</eissn><abstract>ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p<0.001) vs. ASP (figure). Post-meal glucagon levels were lowered by up to 85% and speed of gastric emptying (acetaminophen absorption) reduced by >50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time <70 mg/dL (+13mins) with ADO09. Body weight decreased by 1.6 kg with ADO09 (p=0.007) as did daily prandial insulin doses (-12 U vs. ASP, median 35.0 U vs. 47.3; p=0.0004). Slightly more hypoglycemic episodes were noted with ADO09 (n=96 vs. 79) with no difference in nocturnal hypoglycemia. While more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite). In conclusion, ADO09 improved blood glucose control and reduced both body weight and prandial insulin doses vs. insulin aspart in T1D subjects with high prandial insulin needs.</abstract><cop>New York</cop><pub>American Diabetes Association</pub><doi>10.2337/db21-197-OR</doi></addata></record>
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subjects	Acetaminophen Appetite loss Blood glucose Body weight Diabetes Gastric emptying Glucagon Glucose Hypoglycemia Insulin Nausea
title	197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D
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