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Efficacy and Safety of Once-Weekly Semaglutide vs. Once-Daily Insulin Glargine in Insulin-Naïve Subjects with Type 2 Diabetes (SUSTAIN 4)
Abstracts / Can J Diabetes 40 (2016) S27–S74
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Efficacy and Safety of Once-Weekly Semaglutide vs. Exenatide ER after 56 Weeks in Subjects with Type 2 Diabetes (SUSTAIN 3) IRENE HRAMIAK*,†, ANDREW AHMANN†, MATTHEW CAPETHORN†, GUILLAUME CHARPENTIER, FRANCESCO DOTTA, ELENA HENKELILDIKO LINGVAY†, ANDERS GAARSDAL HOLST†, MIRIAM ANNETT†, VANITA R. ARODA† London, ON
Efficacy and Safety of Once-Weekly Semaglutide vs. Once-Daily Insulin Glargine in Insulin-Naïve Subjects with Type 2 Diabetes (SUSTAIN 4) JOANNE LIUTKUS*,†, VANITA R. ARODA†, STEPHEN C. BAIN†, BERTRAND CARIOU†, MILIVOJ PILETIC†, LUDGER ROSEMADS AXELSEN†, EVERTON ROWE†, JHAN S. DEVRIES† Cambridge, ON
Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for the treatment of type 2 diabetes (T2D). In this 56-week, open-label study, 813 adults with T2D inadequately controlled on 1 to 2 oral antidiabetic drugs (OADs; metformin, sulfonylurea, thiazolidinediones) were randomized 1:1 to once-weekly semaglutide 1.0 mg or once-weekly exenatide extended release (ER) 2.0 mg. Primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to Week 56. Baseline characteristics were similar in both arms; mean age 56.6 years, duration of T2D 9.2 years. Mean HbA1c (baseline 8.3%) was reduced by 1.5% with semaglutide and 0.9% with exenatide ER(estimated treatment difference [ETD] vs. exenatide ER –0.62%; p<0.0001). HbA1c <7% was achieved by 67% and 40% of semaglutideand exenatide ER-treated subjects. Mean body weight (BW; baseline 95.8 kg) was reduced by 5.6 kg with semaglutide and 1.9 kg with exenatide ER (ETD –3.73 kg; p<0.0001). For semaglutide and exenatide ER, serious adverse events (AEs) were reported in 9.4% and 5.9%; 9.4% and 7.2% had AEs leading to treatment discontinuation; 41.8% and 33.3% reported gastrointestinal AEs and 1.2% and 22.0% reported injection-site reactions, respectively. In the semaglutide arm, 2 fatal events occurred (both neoplasms judged as unrelated to treatment). Once-weekly semaglutide was superior to exenatide ER in improving glycemic control and reducing BW in subjects with T2D inadequately controlled on 1 to 2 OADs. Semaglutide was well tolerated with a similar safety profile to other GLP-1 receptor agonists.
This trial evaluated the efficacy, safety and tolerability of subcutaneous semaglutide vs. insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes (T2D). In this phase 3a, randomized, open-label study, 1082 adults with T2D (glycated hemoglobin [HbA1c] 7 to 10%) received semaglutide (0.5 or 1.0 mg) once-weekly or IGlar (starting dose 10 IU/day) oncedaily for 30 weeks, added to stable metformin±sulfonylurea. Primary endpoint: change in HbA1c (baseline to Week 30). Mean HbA1c (baseline 8.2%) was reduced with semaglutide 0.5 and 1.0 mg by 1.2% and 1.6% vs. 0.8% with IGlar (estimated treatment difference [ETD] vs. IGlar –0.38% and –0.81%; both p<0.0001). Mean IGlar dose at Week 30: 29.2 IU/day. HbA1c <7% was achieved by 57.5%, 73.3% and 38.1%; 37.3%, 54.2% and 17.5% achieved HbA1c ≤6.5%, respectively. See Table for other secondary endpoints. Mean body weight (BW; baseline 93.4 kg) decreased by 3.5 and 5.2 kg vs. a 1.2 kg increase (ETD –4.62 kg and –6.34 kg; both p<0.0001). Adverse events (AEs) were reported by 69.9%, 73.3% and 65.3% with semaglutide 0.5, 1.0 mg and IGlar, respectively; 6.1%, 4.7% and 5.0% reported serious AEs. Four fatal AEs were reported with semaglutide and 2 with IGlar. Discontinuation due to AEs occurred in 5.5%, 7.5% and 1.1% of patients, respectively; the majority gastrointestinal (GI)related AEs. Mild, transient GI AEs were the most common AEs with semaglutide. Severe hypoglycemia: reported by 4.4%, 5.6% and 10.6% of subjects, respectively. Semaglutide (0.5 and 1.0 mg once-weekly) provided superior glycemic control and BW reduction vs. IGlar in patients with T2D treated with metformin±sulfonylurea.
111 Efficacy and Safety of Semaglutide Once-Weekly vs. Placebo as Add-on to Basal Insulin Alone or in Combination with Metformin in Subjects with Type 2 Diabetes (SUSTAIN 5) ROBIN CONWAY*,†, HELENA RODBARD†, ILDIKO LINGVAY†, JOHN REED, RAYMOND DELA ROSA†, LUDGER ROSE, DANNY SUGIMOTO, EIICHI ARAKI, PEI-LING CHU†, NELUN WIJAYASINGHE†, PAUL NORWOOD Smiths Falls, ON This study evaluated efficacy and safety of subcutaneous semaglutide (0.5 and 1.0 mg) vs. placebo in subjects with type 2 diabetes (T2D) treated with basal insulin±metformin.
S41
109
110
Efficacy and Safety of Once-Weekly Semaglutide vs. Exenatide ER after 56 Weeks in Subjects with Type 2 Diabetes (SUSTAIN 3) IRENE HRAMIAK*,†, ANDREW AHMANN†, MATTHEW CAPETHORN†, GUILLAUME CHARPENTIER, FRANCESCO DOTTA, ELENA HENKELILDIKO LINGVAY†, ANDERS GAARSDAL HOLST†, MIRIAM ANNETT†, VANITA R. ARODA† London, ON
Efficacy and Safety of Once-Weekly Semaglutide vs. Once-Daily Insulin Glargine in Insulin-Naïve Subjects with Type 2 Diabetes (SUSTAIN 4) JOANNE LIUTKUS*,†, VANITA R. ARODA†, STEPHEN C. BAIN†, BERTRAND CARIOU†, MILIVOJ PILETIC†, LUDGER ROSEMADS AXELSEN†, EVERTON ROWE†, JHAN S. DEVRIES† Cambridge, ON
Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for the treatment of type 2 diabetes (T2D). In this 56-week, open-label study, 813 adults with T2D inadequately controlled on 1 to 2 oral antidiabetic drugs (OADs; metformin, sulfonylurea, thiazolidinediones) were randomized 1:1 to once-weekly semaglutide 1.0 mg or once-weekly exenatide extended release (ER) 2.0 mg. Primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to Week 56. Baseline characteristics were similar in both arms; mean age 56.6 years, duration of T2D 9.2 years. Mean HbA1c (baseline 8.3%) was reduced by 1.5% with semaglutide and 0.9% with exenatide ER(estimated treatment difference [ETD] vs. exenatide ER –0.62%; p<0.0001). HbA1c <7% was achieved by 67% and 40% of semaglutideand exenatide ER-treated subjects. Mean body weight (BW; baseline 95.8 kg) was reduced by 5.6 kg with semaglutide and 1.9 kg with exenatide ER (ETD –3.73 kg; p<0.0001). For semaglutide and exenatide ER, serious adverse events (AEs) were reported in 9.4% and 5.9%; 9.4% and 7.2% had AEs leading to treatment discontinuation; 41.8% and 33.3% reported gastrointestinal AEs and 1.2% and 22.0% reported injection-site reactions, respectively. In the semaglutide arm, 2 fatal events occurred (both neoplasms judged as unrelated to treatment). Once-weekly semaglutide was superior to exenatide ER in improving glycemic control and reducing BW in subjects with T2D inadequately controlled on 1 to 2 OADs. Semaglutide was well tolerated with a similar safety profile to other GLP-1 receptor agonists.
This trial evaluated the efficacy, safety and tolerability of subcutaneous semaglutide vs. insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes (T2D). In this phase 3a, randomized, open-label study, 1082 adults with T2D (glycated hemoglobin [HbA1c] 7 to 10%) received semaglutide (0.5 or 1.0 mg) once-weekly or IGlar (starting dose 10 IU/day) oncedaily for 30 weeks, added to stable metformin±sulfonylurea. Primary endpoint: change in HbA1c (baseline to Week 30). Mean HbA1c (baseline 8.2%) was reduced with semaglutide 0.5 and 1.0 mg by 1.2% and 1.6% vs. 0.8% with IGlar (estimated treatment difference [ETD] vs. IGlar –0.38% and –0.81%; both p<0.0001). Mean IGlar dose at Week 30: 29.2 IU/day. HbA1c <7% was achieved by 57.5%, 73.3% and 38.1%; 37.3%, 54.2% and 17.5% achieved HbA1c ≤6.5%, respectively. See Table for other secondary endpoints. Mean body weight (BW; baseline 93.4 kg) decreased by 3.5 and 5.2 kg vs. a 1.2 kg increase (ETD –4.62 kg and –6.34 kg; both p<0.0001). Adverse events (AEs) were reported by 69.9%, 73.3% and 65.3% with semaglutide 0.5, 1.0 mg and IGlar, respectively; 6.1%, 4.7% and 5.0% reported serious AEs. Four fatal AEs were reported with semaglutide and 2 with IGlar. Discontinuation due to AEs occurred in 5.5%, 7.5% and 1.1% of patients, respectively; the majority gastrointestinal (GI)related AEs. Mild, transient GI AEs were the most common AEs with semaglutide. Severe hypoglycemia: reported by 4.4%, 5.6% and 10.6% of subjects, respectively. Semaglutide (0.5 and 1.0 mg once-weekly) provided superior glycemic control and BW reduction vs. IGlar in patients with T2D treated with metformin±sulfonylurea.
111 Efficacy and Safety of Semaglutide Once-Weekly vs. Placebo as Add-on to Basal Insulin Alone or in Combination with Metformin in Subjects with Type 2 Diabetes (SUSTAIN 5) ROBIN CONWAY*,†, HELENA RODBARD†, ILDIKO LINGVAY†, JOHN REED, RAYMOND DELA ROSA†, LUDGER ROSE, DANNY SUGIMOTO, EIICHI ARAKI, PEI-LING CHU†, NELUN WIJAYASINGHE†, PAUL NORWOOD Smiths Falls, ON This study evaluated efficacy and safety of subcutaneous semaglutide (0.5 and 1.0 mg) vs. placebo in subjects with type 2 diabetes (T2D) treated with basal insulin±metformin.